Eribulin With Trastuzumab as First-line Therapy for Local... | NCT01269346

NCT01269346

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: Eribulin Mesylate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eribulin Mesylate	Drug	Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Response Rate	The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant's overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.	Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR

Secondary Outcomes

Measure	Description	Time Frame
Time to First Response	Time to first response was defined for participants whose best overall response was a CR or PR.	From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months
Duration of Response (DOR)

Eligibility Module

Eligibility Criteria

Key Inclusion criteria:

Age 18 years or older
Histologically or cytologically proven adenocarcinoma of the breast
Subjects who have locally recurrent or metastatic disease with at least one measurable lesion
HER2 positive as determined by score of 3 on immunohistochemistry (IHC) staining or gene amplification by fluorescence in situ hybridization (FISH).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0, 1 or 2
At least 12 months since prior neoadjuvant or adjuvant chemotherapy
At least 2 weeks since prior radiotherapy, endocrine therapy, trastuzumab, or lapatinib, with complete recovery from the effects of these interventions
Adequate renal function
Adequate bone marrow function
Adequate liver function
Adequate cardiac function

Key Exclusion criteria:

Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic HER2 breast cancer.
Subjects who have had a prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer
Prior exposure to greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than 720 mg/m2 epirubicin
Inflammatory breast cancer
Prior history of hypertensive crisis or hypertensive encephalopathy
Clinically significant cardiovascular impairment
Subjects with known central nervous system (CNS) disease are not eligible, except for those subjects with treated brain metastasis.
Subjects with metastatic disease limited to bone are ineligible unless there is at least one lytic lesion with identifiable soft tissue components that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI)
Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
History of bleeding diasthesis
Currently pregnant or breast-feeding.
Subjects with preexisting Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade less than or equal to 2 before enrollment

Contacts/Locations Module

Name	Affiliation	Role
Sam Misir	Eisai Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado		Denver	Colorado	80204	United States
Florida Cancer Care

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Eribulin Mesylate in Combination With Trastuzumab	Eribulin Mesylate: Eribulin mesylate 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. Trastuzumab 8 mg/kg was administered as an IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Full analysis set (FAS) included all participants who received at least one dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Eribulin Mesylate in Combination With Trastuzumab	Eribulin Mesylate: Eribulin mesylate 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. Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Geometric Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00071.2(56.92 to 82.87)

Secondary

Time to First Response

Time to first response was defined for participants whose best overall response was a CR or PR.

FAS included all participants who received at least one dose of study drug. Analyzed for responders (CR or PR) only.

Posted

Median

95% Confidence Interval

Months

From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months

ID	Title	Description
OG000	Eribulin Mesylate in Combination With Trastuzumab	Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Units	Counts
Participants	OG000

Secondary

Duration of Response (DOR)

Duration of response was defined for participants whose best overall response was CR or PR. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were alive at the end of the study without reported PD were censored on the date of their last tumor assessment.

FAS included all participants who received at least one dose of study drug. Analyzed for responders only (n = 37).

Posted

Median

95% Confidence Interval

Months

Date of a confirmed CR or PR was first documented to the date of PD or death (due to any cause and in the absence of PD), whichever occurred first, or date of data cutoff (12 Sep 2013), or up to approximately 2 years 9 months

ID	Title	Description
OG000	Eribulin Mesylate in Combination With Trastuzumab	Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Units	Counts
Participants

Secondary

Progression-Free Survival (PFS)

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.

FAS included all participants who received at least one dose of study drug.

Posted

Median

95% Confidence Interval

Months

Date of first dose of study drug to date of PD or death (from any cause) whichever came first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months

ID	Title	Description
OG000	Eribulin Mesylate in Combination With Trastuzumab	Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Units	Counts
Participants

Secondary

Duration of Stable Disease (SD)

Defined as the period from treatment start date to the date of PD or death, whichever occurred first. Participants who were alive without having PD as of the data cutoff date were censored as of their last tumor assessment. Calculated for participants who best response was SD.

FAS included all participants who received at least one dose of study drug.

Posted

Median

95% Confidence Interval

Months

Start of study treatment to date of PD or death, whichever occurred first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months

ID	Title	Description
OG000	Eribulin Mesylate in Combination With Trastuzumab	Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Eribulin Mesylate in Combination With Trastuzumab	Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle. Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle.			15	52	52	52

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDra 16.0	Non-systematic Assessment	EG0001 affected52 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Neutropenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0008 affected52 at risk
Cardiac failure chronic	Cardiac disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Vomiting	Gastrointestinal disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Diarrhoea	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Gastric ulcer	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Gastritis	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Nausea	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Fatigue	General disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Pyrexia	General disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Gastroenteritis	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Lobar pneumonia	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Urinary tract infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Electrocardiogram T wave abnormal	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
White blood cell count decreased	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
Failure to thrive	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hypercalcaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Select	Systematic Assessment	EG0001 affected52 at risk
Headache	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Neuropathy peripheral	Nervous system disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Peripheral sensory neuropathy	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Modified radical mastectomy	Surgical and medical procedures	Select	Systematic Assessment	EG0001 affected52 at risk
Orthostatic hypotension	Vascular disorders	Select	Systematic Assessment	EG0001 affected52 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDra 16.0	Non-systematic Assessment	EG00013 affected52 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Leukocytosis	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Leukopenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0009 affected52 at risk
Lymphadenopathy	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Neutropenia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG00031 affected52 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Bundle branch block right	Cardiac disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Cardiac failure chronic	Cardiac disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Electrocardiogram QT prolonged	Cardiac disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Palpitations	Cardiac disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Pericardial effusion	Cardiac disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Sinus tachycardia	Cardiac disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Tachycardia	Cardiac disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Ear discomfort	Ear and labyrinth disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Ear Pain	Ear and labyrinth disorders	Select	Systematic Assessment	EG0001 affected52 at risk
External ear inflammation	Ear and labyrinth disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Vertigo	Ear and labyrinth disorders	MedDra 16.0	Non-systematic Assessment	EG0001 affected52 at risk
Cataract	Eye disorders	MedDra 16.0	Non-systematic Assessment	EG0003 affected52 at risk
Dacryostenosis acquired	Eye disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Dry eye	Eye disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Eye allergy	Eye disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Eye irritation	Eye disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Lacrimation increased	Eye disorders	Select	Systematic Assessment	EG0008 affected52 at risk
Vision blurred	Eye disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Visual impairment	Eye disorders	Select	Systematic Assessment	EG0005 affected52 at risk
Vitreous detachment	Eye disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Abdominal pain	Gastrointestinal disorders	Select	Systematic Assessment	EG0006 affected52 at risk
Abdominal pain upper	Gastrointestinal disorders	Select	Systematic Assessment	EG0005 affected52 at risk
Aphthous stomatitis	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Constipation	Gastrointestinal disorders	Select	Systematic Assessment	EG00013 affected52 at risk
Diarrhoea	Gastrointestinal disorders	Select	Systematic Assessment	EG00017 affected52 at risk
Dry mouth	Gastrointestinal disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Dyspepsia	Gastrointestinal disorders	Select	Systematic Assessment	EG00010 affected52 at risk
Dysphagia	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Eructation	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Faeces discoloured	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Gastric ulcer	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Gastritis	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Haematochezia	Gastrointestinal disorders	MedDra 16.0	Non-systematic Assessment	EG0001 affected52 at risk
Haemorrhoids	Gastrointestinal disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Lip pain	Gastrointestinal disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Nausea	Gastrointestinal disorders	Select	Systematic Assessment	EG00024 affected52 at risk
Oesophagitis	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Oral pain	Gastrointestinal disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Proctalgia	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Stomatitis	Gastrointestinal disorders	Select	Systematic Assessment	EG0009 affected52 at risk
Swollen tongue	Gastrointestinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Vomiting	Gastrointestinal disorders	Select	Systematic Assessment	EG00012 affected52 at risk
Asthenia	General disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Catheter site pain	General disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Chest discomfort	General disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Chest pain	General disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Chills	General disorders	Select	Systematic Assessment	EG0008 affected52 at risk
Face oedema	General disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Fatigue	General disorders	Select	Systematic Assessment	EG00036 affected52 at risk
Gait disturbance	General disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Influenza like illness	General disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Mucosal inflammation	General disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Oedema	General disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Oedema peripheral	General disorders	Select	Systematic Assessment	EG00012 affected52 at risk
Pain	General disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Pyrexia	General disorders	Select	Systematic Assessment	EG00012 affected52 at risk
Thrombosis in device	General disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hepatic steatosis	Hepatobiliary disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Drug hypersensitivity	Immune system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Food allergy	Immune system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Multiple allergies	Immune system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Seasonal allergy	Immune system disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Breast infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Cellulitis	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Ear infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Fungal skin infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Gastroenteritis	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Influenza	Infections and infestations	Select	Systematic Assessment	EG0002 affected52 at risk
Lobar pneumonia	Infections and infestations	Select	Systematic Assessment	EG0002 affected52 at risk
Nasopharyngitis	Infections and infestations	Select	Systematic Assessment	EG0002 affected52 at risk
Oral candidiasis	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Pharyngitis	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Pharyngotonsillitis	Infections and infestations	MedDra 16.0	Non-systematic Assessment	EG0001 affected52 at risk
Rhinitis	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Sinusitis	Infections and infestations	Select	Systematic Assessment	EG0004 affected52 at risk
Tooth infection	Infections and infestations	Select	Systematic Assessment	EG0002 affected52 at risk
Upper respiratory tract infection	Infections and infestations	Select	Systematic Assessment	EG0004 affected52 at risk
Urinary tract infection	Infections and infestations	Select	Systematic Assessment	EG0007 affected52 at risk
Vulvovaginal mycotic infection	Infections and infestations	Select	Systematic Assessment	EG0001 affected52 at risk
Ankle fracture	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0002 affected52 at risk
Corneal abrasion	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0001 affected52 at risk
Excoriation	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0001 affected52 at risk
Fall	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0001 affected52 at risk
Infusion related reaction	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0001 affected52 at risk
Ligament sprain	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0001 affected52 at risk
Meniscus injury	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0001 affected52 at risk
Muscle strain	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0001 affected52 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	Select	Systematic Assessment	EG0001 affected52 at risk
Alanine aminotransferase increased	Investigations	MedDra 16.0	Non-systematic Assessment	EG0002 affected52 at risk
Aspartate aminotransferase increased	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
Blood alkaline phosphatase increased	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
Blood cholesterol increased	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
Blood phosphorus decreased	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
Ejection fraction decreased	Investigations	Select	Systematic Assessment	EG0003 affected52 at risk
Electrocardiogram T wave abnormal	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
Electrocardiogram abnormal	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
Vitamin D decreased	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
Weight decreased	Investigations	Select	Systematic Assessment	EG0006 affected52 at risk
Weight increased	Investigations	Select	Systematic Assessment	EG0001 affected52 at risk
White blood cell count decreased	Investigations	Select	Systematic Assessment	EG0004 affected52 at risk
Decreased appetite	Metabolism and nutrition disorders	Select	Systematic Assessment	EG00013 affected52 at risk
Dehydration	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Diabetes mellitus	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Failure to thrive	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hypercalcaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hyperuricaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hypocalcaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hypokalaemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDra 16.0	Non-systematic Assessment	EG0001 affected52 at risk
Hyponatraemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Lactose intolerance	Metabolism and nutrition disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0005 affected52 at risk
Back pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0008 affected52 at risk
Bone pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0007 affected52 at risk
Flank pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0007 affected52 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0005 affected52 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Myopathy	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Select	Systematic Assessment	EG0001 affected52 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Select	Systematic Assessment	EG0001 affected52 at risk
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Select	Systematic Assessment	EG0001 affected52 at risk
Ataxia	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Balance disorder	Nervous system disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Carpal tunnel syndrome	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Dizziness	Nervous system disorders	Select	Systematic Assessment	EG0008 affected52 at risk
Dysgeusia	Nervous system disorders	Select	Systematic Assessment	EG00012 affected52 at risk
Headache	Nervous system disorders	Select	Systematic Assessment	EG00010 affected52 at risk
Hypoaesthesia	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Memory impairment	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Migraine	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Neuralgia	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Neuropathy peripheral	Nervous system disorders	Select	Systematic Assessment	EG00031 affected52 at risk
Paraesthesia	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Peripheral motor neuropathy	Nervous system disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Peripheral sensory neuropathy	Nervous system disorders	Select	Systematic Assessment	EG0009 affected52 at risk
Peroneal nerve palsy	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Syncope	Nervous system disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Anxiety	Psychiatric disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Confusional state	Psychiatric disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Depression	Psychiatric disorders	Select	Systematic Assessment	EG0006 affected52 at risk
Insomnia	Psychiatric disorders	Select	Systematic Assessment	EG0007 affected52 at risk
Bladder pain	Renal and urinary disorders	MedDra 16.0	Non-systematic Assessment	EG0001 affected52 at risk
Chromaturia	Renal and urinary disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Dysuria	Renal and urinary disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Haematuria	Renal and urinary disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Pollakiuria	Renal and urinary disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Urinary retention	Renal and urinary disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Bartholin's cyst	Reproductive system and breast disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Breast pain	Reproductive system and breast disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Vulvovaginal discomfort	Reproductive system and breast disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Vulvovaginal dryness	Reproductive system and breast disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0007 affected52 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Alopecia	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG00046 affected52 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Dry skin	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Heat rash	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Night sweats	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Pruritus	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Rash	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0005 affected52 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDra 16.0	Non-systematic Assessment	EG0001 affected52 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Skin fissures	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0002 affected52 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Modified radical mastectomy	Surgical and medical procedures	Select	Systematic Assessment	EG0001 affected52 at risk
Deep vein thrombosis	Vascular disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Flushing	Vascular disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hot flush	Vascular disorders	Select	Systematic Assessment	EG0004 affected52 at risk
Hypertension	Vascular disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Hypotension	Vascular disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Jugular vein thrombosis	Vascular disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Lymphoedema	Vascular disorders	Select	Systematic Assessment	EG0003 affected52 at risk
Orthostatic hypotension	Vascular disorders	Select	Systematic Assessment	EG0001 affected52 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDra 16.0	Non-systematic Assessment	EG0001 affected52 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDra 16.0	Non-systematic Assessment	EG0007 affected52 at risk

ID	Term
D001943	Breast Neoplasms

ID	Term
C490954	eribulin

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases