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A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT01268150
Recruitment Status : Completed
First Posted : December 29, 2010
Results First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Locally Recurrent
Metastatic Breast Cancer ( HER2 Negative)
Intervention Drug: Eribulin mesylate
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
Period Title: Treatment Phase
Started 56
Completed 28
Not Completed 28
Reason Not Completed
Progression of disease             18
Adverse Event             3
Withdrawal by Subject             3
Not specified             4
Period Title: Extension Phase
Started 28 [1]
Treatment Ongoing at Data Cutoff Date 1
Completed 1
Not Completed 27
Reason Not Completed
Adverse Event             3
Disease progression             18
Not specified             6
[1]
28 participants discontinued study drug in Treatment Phase so did not enter the Extension Phase
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
Full analysis set included all participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants
57.0  (10.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
56
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR
Time Frame Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of eribulin mesylate.
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Percentage of participants
28.6
2.Secondary Outcome
Title Time to First Response (CR or PR)
Hide Description Time to first response was defined for participants whose BOR was a CR or PR. Analysis was based on the Kaplan-Meier estimated number of months to CR or PR. This statistical analysis method measures the effect of study drug on CR or PR.
Time Frame Treatment Phase (Day 1 Cycle 1) to earliest date of confirmed objective response (CR or PR), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: Months
1.4
(1.22 to 2.66)
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was measured for participants who were responders only, had attained a BOR that was CR or PR. The duration of response was measured from time that response criteria for CR or PR (whichever was recorded first) were first met until the date that progressive disease (PD) or death from any cause was first objectively documented. Participants who did not have PD were censored on the day of their last tumor assessment. Duration of response was summarized for the responders using Kaplan-Meier estimation method. This statistical analysis method measures the effect of study drug on the length of response time.
Time Frame First date of CR or PR to PD or Death from any cause, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: Months
5.8
(4.67 to 10.55)
4.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment. Participants without evidence of PD upon discontinuation of study drug during the Extension Phase returned to the clinic for disease evaluation and PFS calculation every 12 weeks until PD was documented. PFS was analyzed using Kaplan-Meier product-limit estimates. This statistical analysis method measures the effect of study drug on PFS.
Time Frame Treatment Phase (Day 1 Cycle 1) to date of progressive disease or death, whichever occurred first, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of eribulin mesylate.
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
Overall Number of Participants Analyzed 56
Median (95% Confidence Interval)
Unit of Measure: Months
6.8
(4.44 to 7.59)
5.Other Pre-specified Outcome
Title To Assess the Incidence of Adverse Events (AEs) of Eribulin Mesylate
Hide Description Treatment-emergent adverse events (TEAEs) were defined as AEs that emerged during treatment, having been absent at pretreatment, and occurring within 30 days of the last dose of study treatment, or if they were present prior to the first dose administration and increased in severity during the study. For each AE a participant with two or more TEAEs in that category were counted only once. TEAEs were considered related if the relationship of the event to study drug was possibly or probably related. Serious adverse events (SAEs) were defined as any untoward medical experience that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. Safety information will be summarized with adverse events. AEs were graded on a five-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame Baseline until End of Treatment (within 21 days of last dose), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set population included all participants who received at least one dose of study drug and had at least one postbaseline safety assessment.
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description:
Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: Percentage of participants
TEAEs 100.0
Treatment-related TEAEs 100.0
Serious TEAEs 30.4
Treatment-related Serious TEAEs 8.9
TEAEs leading to withdrawl of study drug 10.7
TEAEs leading to dose reduction 35.7
Time Frame All Treatment-Emergent Adverse events (TEAEs) were collected and followed from the time the participant signed the informed consent form (ICF) until 30 days after discontinuation of study drug or resolution. Participants were followed for up to 2.5 years.
Adverse Event Reporting Description Safety Analysis Set population included all participants who received at least one dose of study drug and had at least one postbaseline safety assessment. AEs were graded on a five-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. AEs rated as Grade 4 or 5 were considered serious.
 
Arm/Group Title Eribulin Mesylate
Hide Arm/Group Description Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
All-Cause Mortality
Eribulin Mesylate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eribulin Mesylate
Affected / at Risk (%)
Total   17/56 (30.36%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  3/56 (5.36%) 
Leukopenia  1  1/56 (1.79%) 
Neutropenia  1  3/56 (5.36%) 
Cardiac disorders   
Pericardial effusion  1  1/56 (1.79%) 
Supraventricular tachycardia  1  1/56 (1.79%) 
Gastrointestinal disorders   
Intestinal perforation  1  1/56 (1.79%) 
Small intestinal obstruction  1  1/56 (1.79%) 
Infections and infestations   
Bronchitis  1  1/56 (1.79%) 
Pyelonephritis  1  1/56 (1.79%) 
Sepsis  1  1/56 (1.79%) 
Urinary tract infection  1  1/56 (1.79%) 
Injury, poisoning and procedural complications   
Femur fracture  1  1/56 (1.79%) 
Metabolism and nutrition disorders   
Dehydration  1  1/56 (1.79%) 
Hypovolaemia  1  1/56 (1.79%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  1/56 (1.79%) 
Pathological fracture  1  1/56 (1.79%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bone neoplasm  1  1/56 (1.79%) 
Nervous system disorders   
Convulsion  1  1/56 (1.79%) 
Headache  1  1/56 (1.79%) 
Spinal cord paralysis  1  1/56 (1.79%) 
Psychiatric disorders   
Mental status changes  1  1/56 (1.79%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/56 (1.79%) 
Pulmonary embolism  1  2/56 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eribulin Mesylate
Affected / at Risk (%)
Total   56/56 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  21/56 (37.50%) 
Febrile neutropenia  1  4/56 (7.14%) 
Leukopenia  1  19/56 (33.93%) 
Lymphadenopathy  1  1/56 (1.79%) 
Lymphopenia  1  5/56 (8.93%) 
Neutropenia  1  40/56 (71.43%) 
Thrombocytopenia  1  3/56 (5.36%) 
Cardiac disorders   
Angina Pectoris  1  2/56 (3.57%) 
Electrocardiogram QT prolonged  1  2/56 (3.57%) 
Palpitations  1  1/56 (1.79%) 
Pericardial effusion  1  2/56 (3.57%) 
Sinus tachycardia  1  1/56 (1.79%) 
Supraventricular tachycardia  1  1/56 (1.79%) 
Ear and labyrinth disorders   
Ear Pain  1  1/56 (1.79%) 
Eustachian tube dysfunction  1  1/56 (1.79%) 
Middle ear effusion  1  1/56 (1.79%) 
Tinnitus  1  1/56 (1.79%) 
Eye disorders   
Abnormal sensation in eye  1  1/56 (1.79%) 
Cataract  1  3/56 (5.36%) 
Dry Eye  1  1/56 (1.79%) 
Lacrimation increased  1  7/56 (12.50%) 
Visual Impairment  1  1/56 (1.79%) 
Gastrointestinal disorders   
Abdominal distension  1  1/56 (1.79%) 
Abdominal Pain  1  5/56 (8.93%) 
Abdominal Pain Lower  1  2/56 (3.57%) 
Abdominal pain upper  1  4/56 (7.14%) 
Anal haemorrhage  1  1/56 (1.79%) 
Aphthous stomatitis  1  1/56 (1.79%) 
Ascites  1  1/56 (1.79%) 
Constipation  1  20/56 (35.71%) 
Dental caries  1  1/56 (1.79%) 
Diarrhoea  1  19/56 (33.93%) 
Diverticulum intestinal  1  1/56 (1.79%) 
Dry mouth  1  6/56 (10.71%) 
Dyspepsia  1  5/56 (8.93%) 
Food poisoning  1  1/56 (1.79%) 
Frequent bowel movements  1  1/56 (1.79%) 
Gastrooesophageal reflux disease  1  2/56 (3.57%) 
Haemorrhoidal haemorrhage  1  1/56 (1.79%) 
Haemorrhoids  1  3/56 (5.36%) 
Hypoaesthesia oral  1  1/56 (1.79%) 
Intestinal perforation  1  1/56 (1.79%) 
Lip dry  1  1/56 (1.79%) 
Nausea  1  33/56 (58.93%) 
Oral disorder  1  1/56 (1.79%) 
Paraesthesia oral  1  1/56 (1.79%) 
Rectal fissure  1  2/56 (3.57%) 
Rectal haemorrhage  1  1/56 (1.79%) 
Salivary gland enlargement  1  1/56 (1.79%) 
Salivary gland mass  1  1/56 (1.79%) 
Small intestinal obstruction  1  1/56 (1.79%) 
Stomatitis  1  6/56 (10.71%) 
Tongue discolouration  1  1/56 (1.79%) 
Tooth deposit  1  1/56 (1.79%) 
Vomiting  1  14/56 (25.00%) 
General disorders   
Asthenia  1  3/56 (5.36%) 
Axillary pain  1  1/56 (1.79%) 
Catheter site erythema  1  1/56 (1.79%) 
Catheter site inflammation  1  2/56 (3.57%) 
Catheter site pain  1  1/56 (1.79%) 
Catheter site rash  1  1/56 (1.79%) 
Chills  1  2/56 (3.57%) 
Fatigue  1  36/56 (64.29%) 
Gait disturbance  1  2/56 (3.57%) 
Inflammation  1  1/56 (1.79%) 
Influenza like illness  1  2/56 (3.57%) 
Mucosal inflammation  1  1/56 (1.79%) 
Non-cardiac chest pain  1  1/56 (1.79%) 
Oedema Peripheral  1  11/56 (19.64%) 
Pain  1  2/56 (3.57%) 
Pyrexia  1  10/56 (17.86%) 
Hepatobiliary disorders   
Hyperbilirubinaemia  1  1/56 (1.79%) 
Immune system disorders   
Seasonal allergy  1  1/56 (1.79%) 
Infections and infestations   
Abdominal abscess  1  1/56 (1.79%) 
Acute sinusitis  1  1/56 (1.79%) 
Bronchitis  1  2/56 (3.57%) 
Candidiadis  1  2/56 (3.57%) 
Catheter Site infection  1  2/56 (3.57%) 
Cellulitis  1  2/56 (3.57%) 
Diverticulitis  1  1/56 (1.79%) 
Gastroenteritis  1  1/56 (1.79%) 
Localised infection  1  1/56 (1.79%) 
Mastoiditis  1  1/56 (1.79%) 
Oral candidiasis  1  2/56 (3.57%) 
Oral herpes  1  2/56 (3.57%) 
Pleural infection  1  1/56 (1.79%) 
Pneumonia  1  1/56 (1.79%) 
Pyelonephritis  1  1/56 (1.79%) 
Sepsis  1  1/56 (1.79%) 
Sinusitis  1  6/56 (10.71%) 
Upper respiratory tract infection  1  3/56 (5.36%) 
Urinary tract infection  1  11/56 (19.64%) 
Vaginal infection  1  1/56 (1.79%) 
Vulvovaginal candidiasis  1  1/56 (1.79%) 
Vulvovaginal mycotic infection  1  2/56 (3.57%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  2/56 (3.57%) 
Contusion  1  2/56 (3.57%) 
Fall  1  3/56 (5.36%) 
Femur fracture  1  1/56 (1.79%) 
Foot fracture  1  1/56 (1.79%) 
Joint injury  1  1/56 (1.79%) 
Laceration  1  1/56 (1.79%) 
Procedural pain  1  1/56 (1.79%) 
Thermal burn  1  1/56 (1.79%) 
Tooth fracture  1  1/56 (1.79%) 
Vascular access complication  1  1/56 (1.79%) 
Investigations   
Alanine aminotransferase increased  1  2/56 (3.57%) 
Aspartate aminotransferase increased  1  1/56 (1.79%) 
Blood alkaline phosphatase increased  1  1/56 (1.79%) 
Blood creatinine increased  1  2/56 (3.57%) 
Blood glucose increased  1  1/56 (1.79%) 
Blood phosphorus decreased  1  1/56 (1.79%) 
Haemoglobin decreased  1  1/56 (1.79%) 
Helicobacter test positive  1  1/56 (1.79%) 
International normalised ratio increased  1  2/56 (3.57%) 
Liver function test abnormal  1  2/56 (3.57%) 
Lymphocyte count decreased  1  1/56 (1.79%) 
Platelet count increased  1  1/56 (1.79%) 
Prothrombin time prolonged  1  1/56 (1.79%) 
Weight decreased  1  9/56 (16.07%) 
Weight increased  1  1/56 (1.79%) 
White blood cell count decreased  1  1/56 (1.79%) 
White blood cell count increased  1  2/56 (3.57%) 
Metabolism and nutrition disorders   
Decreased appetite  1  15/56 (26.79%) 
Dehydration  1  2/56 (3.57%) 
Diabetes mellitus  1  2/56 (3.57%) 
Fluid retention  1  1/56 (1.79%) 
Hyperglycaemia  1  1/56 (1.79%) 
Hyperphosphataemia  1  1/56 (1.79%) 
Hypoalbuminaemia  1  4/56 (7.14%) 
Hypocalcaemia  1  1/56 (1.79%) 
Hypokalaemia  1  8/56 (14.29%) 
Hypomagnesaemia  1  1/56 (1.79%) 
Hyponatraemia  1  2/56 (3.57%) 
Hypophosphataemia  1  2/56 (3.57%) 
Hypovolaemia  1  1/56 (1.79%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  8/56 (14.29%) 
Back pain  1  11/56 (19.64%) 
Bone pain  1  5/56 (8.93%) 
Bunion  1  1/56 (1.79%) 
Groin pain  1  1/56 (1.79%) 
Joint swelling  1  1/56 (1.79%) 
Muscle spasms  1  7/56 (12.50%) 
Muscular weakness  1  3/56 (5.36%) 
Musculoskeletal chest pain  1  7/56 (12.50%) 
Musculoskeletal deformity  1  1/56 (1.79%) 
Musculoskeletal pain  1  4/56 (7.14%) 
Myalgia  1  5/56 (8.93%) 
Neck pain  1  2/56 (3.57%) 
Pain in extremity  1  6/56 (10.71%) 
Pain in jaw  1  3/56 (5.36%) 
Pathological fracture  1  2/56 (3.57%) 
Pubic pain  1  1/56 (1.79%) 
Trigger finger  1  1/56 (1.79%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bone neoplasm  1  1/56 (1.79%) 
Metastases to spine  1  1/56 (1.79%) 
Skin papilloma  1  1/56 (1.79%) 
Tumour pain  1  1/56 (1.79%) 
Nervous system disorders   
Ageusia  1  1/56 (1.79%) 
Ataxia  1  1/56 (1.79%) 
Balance Disorder  1  1/56 (1.79%) 
Convulsion  1  2/56 (3.57%) 
Disturbance in attention  1  1/56 (1.79%) 
Dizziness  1  6/56 (10.71%) 
Dysgeusia  1  9/56 (16.07%) 
Head discomfort  1  1/56 (1.79%) 
Headache  1  13/56 (23.21%) 
Hypoaesthesia  1  3/56 (5.36%) 
Hypogeusia  1  1/56 (1.79%) 
Lethargy  1  1/56 (1.79%) 
Lumbar radiculopathy  1  1/56 (1.79%) 
Memory impairment  1  2/56 (3.57%) 
Peroneal nerve palsy  1  1/56 (1.79%) 
Radiculopathy  1  1/56 (1.79%) 
Restless legs syndrome  1  1/56 (1.79%) 
Sinus headache  1  1/56 (1.79%) 
Somnolence  1  1/56 (1.79%) 
Spinal cord paralysis  1  1/56 (1.79%) 
Peripheral Neuropathy  1  34/56 (60.71%) 
Neuropathy peripheral  1  26/56 (46.43%) 
Paraesthesia  1  4/56 (7.14%) 
Peripheral motor neuropathy  1  2/56 (3.57%) 
Peripheral sensory neuropathy  1  12/56 (21.43%) 
Dysarthria  1  1/56 (1.79%) 
Psychiatric disorders   
Affect lability  1  1/56 (1.79%) 
Anxiety  1  3/56 (5.36%) 
Depression  1  6/56 (10.71%) 
Disorientation  1  1/56 (1.79%) 
Hallucination  1  1/56 (1.79%) 
Insomnia  1  8/56 (14.29%) 
Mental status changes  1  1/56 (1.79%) 
Renal and urinary disorders   
Dysuria  1  9/56 (16.07%) 
Hydronephrosis  1  1/56 (1.79%) 
Micturition urgency  1  1/56 (1.79%) 
Pollakiuria  1  4/56 (7.14%) 
Proteinuria  1  1/56 (1.79%) 
Urinary incontinence  1  2/56 (3.57%) 
Urinary retention  1  2/56 (3.57%) 
Urinary tract obstruction  1  1/56 (1.79%) 
Reproductive system and breast disorders   
Breast pain  1  3/56 (5.36%) 
Pelvic pain  1  1/56 (1.79%) 
Vulvovaginal dryness  1  1/56 (1.79%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  13/56 (23.21%) 
Dry throat  1  1/56 (1.79%) 
Dysphonia  1  2/56 (3.57%) 
Dyspnoea  1  7/56 (12.50%) 
Dyspnoea exertional  1  2/56 (3.57%) 
Epistaxis  1  1/56 (1.79%) 
Hiccups  1  1/56 (1.79%) 
Nasal congestion  1  3/56 (5.36%) 
Oropharyngeal pain  1  3/56 (5.36%) 
Paranasal sinus hypersecretion  1  1/56 (1.79%) 
Pleural effusion  1  1/56 (1.79%) 
Productive cough  1  1/56 (1.79%) 
Pulmonary embolism  1  3/56 (5.36%) 
Respiratory tract congestion  1  1/56 (1.79%) 
Rhinitis allergic  1  1/56 (1.79%) 
Rhinorrhoea  1  3/56 (5.36%) 
Throat irritation  1  1/56 (1.79%) 
Upper-airway cough syndrome  1  1/56 (1.79%) 
Skin and subcutaneous tissue disorders   
Acne  1  1/56 (1.79%) 
Alopecia  1  47/56 (83.93%) 
Dermatitis acneiform  1  1/56 (1.79%) 
Dermatitis bullous  1  1/56 (1.79%) 
Dry skin  1  3/56 (5.36%) 
Eczema  1  3/56 (5.36%) 
Hyperkeratosis  1  1/56 (1.79%) 
Ingrown hair  1  1/56 (1.79%) 
Nail discolouration  1  1/56 (1.79%) 
Nail disorder  1  3/56 (5.36%) 
Night sweats  1  5/56 (8.93%) 
Onychoclasis  1  1/56 (1.79%) 
Pruritus  1  3/56 (5.36%) 
Rash  1  4/56 (7.14%) 
Rash maculo-papular  1  1/56 (1.79%) 
Rash pruritic  1  1/56 (1.79%) 
Skin disorder  1  2/56 (3.57%) 
Skin irritation  1  1/56 (1.79%) 
Vascular disorders   
Deep vein thrombosis  1  3/56 (5.36%) 
Flushing  1  1/56 (1.79%) 
Hot flush  1  5/56 (8.93%) 
Hypertension  1  1/56 (1.79%) 
Hypotension  1  2/56 (3.57%) 
Lymphoedema  1  2/56 (3.57%) 
Pallor  1  1/56 (1.79%) 
Phlebitis  1  2/56 (3.57%) 
Thrombophlebitis superficial  1  1/56 (1.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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: NCT01268150     History of Changes
Other Study ID Numbers: E7389-A001-206
First Submitted: December 28, 2010
First Posted: December 29, 2010
Results First Submitted: May 11, 2016
Results First Posted: August 9, 2016
Last Update Posted: August 9, 2016