Pivotal Study in HER2 Negative, Locally Recurrent or Meta... | NCT03786094

Label	Type	Description	Intervention Names
Eribulin	Active Comparator		Drug: Eribulin
Balixafortide + Eribulin	Experimental		Drug: Eribulin Drug: Balixafortide

Name	Type	Description	Arm Group Labels	Other Names
Eribulin	Drug	Eribulin alone	Balixafortide + Eribulin Eribulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (2nd Line+ Population)	To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored. PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).	Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.
Progression Free Survival (3rd Line+ Population)	To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored. PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).	Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (3rd Line+ Population)	To compare the overall survival (OS) between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm. OS is defined as the time from date of randomization to date of death due to any cause. Patients who are lost to follow-up or are not known to have died at the time of data-cut-off for analysis or who do not have any follow up since randomization were censored.

Name	Affiliation	Role
François Ringeisen, MD	Polyphor Ltd.	Study Director
Peter A Kaufman, MD	UVM medical center; USA	Principal Investigator
Javier Cortes, MD	IOB and VHIO; Spain	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
California Cancer Associates for Research and Excellence		Fresno	California	93720	United States

ID	Title	Description
FG000	Balixafortide + Eribulin	Balixafortide: Balixafortide + Eribulin Balixafortide was administered as a single IV administration (5.5 mg/kg over at least 2 hours [±10 minutes]) on Days 1-3 and Days 8-10 of each 21-day cycle. Eribulin was administered IV at a dose of 1.4 mg/m2 over 2 to 5 minutes on Days 2 and 9 of each 21-day cycle.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 15, 2019	Aug 13, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (2nd Line+ Population)

To evaluate the efficacy of balixafortide + eribulin versus eribulin monotherapy on the primary endpoint of progression free survival (PFS). PFS, as assessed by the Independent Review Committee, defined as the time from the date of randomization to the earliest evidence of documented progressive disease or death from any cause. Patients who were alive without postbaseline assessments or without documented progressive disease, lost to follow-up, withdrew consent, started an anticancer therapy prior to observing a progressive disease or with an event documented after 2 or more missing tumor assessments were censored.

PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

Overall Population (2nd Line+)

Posted

Median

95% Confidence Interval

months

Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.

ID	Title	Description
OG000	Balixafortide + Eribulin	Balixafortide: Balixafortide + Eribulin
OG001	Eribulin Monotherapy	Eribulin: Eribulin alone

Units	Counts
Participants	OG000219 OG001213

Title

Denominators

Categories

Title	Measurements
	OG0003.5(2.8 to 4.2) OG0014.0(3.0 to 4.3)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.4450		Hazard Ratio (HR)	1.10			2-Sided	96	0.85	1.41			HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.		Superiority

Primary

Progression Free Survival (3rd Line+ Population)

PFS was evaluated according to RECIST v1.1 guidelines for complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).

3rd Line+ Population

Posted

Median

95% Confidence Interval

months

Patients received treatment until PD by RECIST v1.1 criteria was met or until one of the treatment discontinuation or study withdrawal criteria was met.

ID	Title	Description
OG000	Balixafortide + Eribulin	Balixafortide: Balixafortide + Eribulin
OG001	Eribulin Monotherapy	Eribulin: Eribulin alone

Units

Secondary

Overall Survival (3rd Line+ Population)

To compare the overall survival (OS) between patients in the balixafortide + eribulin treatment arm versus eribulin monotherapy treatment arm. OS is defined as the time from date of randomization to date of death due to any cause. Patients who are lost to follow-up or are not known to have died at the time of data-cut-off for analysis or who do not have any follow up since randomization were censored.

3rd Line+ Population

Posted

Median

95% Confidence Interval

months

The Investigator monitored the patient for OS status every 6 months (or more frequently) until: death, the patient withdrew consent to follow-up for survival, or until the patient was lost to follow-up (whichever occurred first).

ID	Title	Description
OG000	Balixafortide + Eribulin	Balixafortide: Balixafortide + Eribulin
OG001	Eribulin Monotherapy	Eribulin: Eribulin alone

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0005 affected218 at risk EG0015 affected204 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0003 affected218 at risk EG0015 affected204 at risk
Sepsis	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0003 affected218 at risk EG0013 affected204 at risk
Device related infection	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0012 affected204 at risk
Erysipelas	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected204 at risk
Neutropenic infection	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0002 affected218 at risk EG0010 affected204 at risk
Urinary tract infection	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected204 at risk
Arthritis infective	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Atypical pneumonia	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Breast cellulitis	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
COVID-19	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Dermatitis infected	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Gastroenteritis	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Septic shock	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Sinusitis	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Tonsillitis	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Urosepsis	Infections and infestations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0005 affected218 at risk EG0019 affected204 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0012 affected204 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0002 affected218 at risk EG0011 affected204 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0004 affected218 at risk EG0012 affected204 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0004 affected218 at risk EG0011 affected204 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0012 affected204 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected204 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Immune-mediated pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Disease progression	General disorders	MedDRA, Version 23.0	Systematic Assessment	EG0005 affected218 at risk EG0015 affected204 at risk
General physical health deterioration	General disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected204 at risk
Asthenia	General disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected204 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected204 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG0002 affected218 at risk EG0010 affected204 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA, Version 23.0	Systematic Assessment	EG0005 affected218 at risk EG0010 affected204 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA, Version 23.0	Systematic Assessment	EG0002 affected218 at risk EG0010 affected204 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Constipation	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Gastritis	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Malignant gastrointestinal obstruction	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Nausea	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Oesophageal compression	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Stomatitis	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Syncope	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected204 at risk
Brain oedema	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Chronic inflammatory demyelinating polyradiculoneuropathy	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Epilepsy	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Hemiparesis	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0013 affected204 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 23.0	Systematic Assessment	EG0002 affected218 at risk EG0010 affected204 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Malignant pleural effusion	Metabolism and nutrition disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Metastases to central nervous system	Metabolism and nutrition disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Renal failure	Renal and urinary disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0011 affected204 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Cardiac tamponade	Cardiac disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Myocardial infarction	Cardiac disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Sinus tachycardia	Cardiac disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Hypotension	Vascular disorders	MedDRA, Version 23.0	Systematic Assessment	EG0002 affected218 at risk EG0010 affected204 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk
Transaminases increased	Investigations	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Confusional state	Psychiatric disorders	MedDRA, Version 23.0	Systematic Assessment	EG0001 affected218 at risk EG0010 affected204 at risk
Lens extraction	Surgical and medical procedures	MedDRA, Version 23.0	Systematic Assessment	EG0000 affected218 at risk EG0011 affected204 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Alopecia	Skin and subcutaneous tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG00059 affected218 at risk EG00162 affected204 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG00055 affected218 at risk EG0011 affected204 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA, Version 23.0	Systematic Assessment	EG00023 affected218 at risk EG0010 affected204 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA, Version 23.0	Systematic Assessment	EG00057 affected218 at risk EG00168 affected204 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA, Version 23.0	Systematic Assessment	EG00027 affected218 at risk EG00133 affected204 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA, Version 23.0	Systematic Assessment	EG00018 affected218 at risk EG00120 affected204 at risk
Asthenia	General disorders	MedDRA, Version 23.0	Systematic Assessment	EG00041 affected218 at risk EG00140 affected204 at risk
Fatigue	General disorders	MedDRA, Version 23.0	Systematic Assessment	EG00029 affected218 at risk EG00135 affected204 at risk
Pyrexia	General disorders	MedDRA, Version 23.0	Systematic Assessment	EG00011 affected218 at risk EG00113 affected204 at risk
Nausea	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG00044 affected218 at risk EG00140 affected204 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG00017 affected218 at risk EG00127 affected204 at risk
Stomatitis	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG00025 affected218 at risk EG00111 affected204 at risk
Constipation	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG00016 affected218 at risk EG00119 affected204 at risk
Vomiting	Gastrointestinal disorders	MedDRA, Version 23.0	Systematic Assessment	EG00014 affected218 at risk EG00111 affected204 at risk
Neutrophil count decreased	Investigations	MedDRA, Version 23.0	Systematic Assessment	EG00034 affected218 at risk EG00135 affected204 at risk
Alanine aminotransferase increased	Investigations	MedDRA, Version 23.0	Systematic Assessment	EG00014 affected218 at risk EG00115 affected204 at risk
White blood cell count decreased	Investigations	MedDRA, Version 23.0	Systematic Assessment	EG00012 affected218 at risk EG00116 affected204 at risk
Aspartate aminotransferase increased	Investigations	MedDRA, Version 23.0	Systematic Assessment	EG0008 affected218 at risk EG00118 affected204 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG00018 affected218 at risk EG00114 affected204 at risk
Dysgeusia	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG00012 affected218 at risk EG00110 affected204 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA, Version 23.0	Systematic Assessment	EG00012 affected218 at risk EG00110 affected204 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA, Version 23.0	Systematic Assessment	EG00095 affected218 at risk EG0010 affected204 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA, Version 23.0	Systematic Assessment	EG00022 affected218 at risk EG00112 affected204 at risk

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

ID	Title	Description
BG000	Balixafortide + Eribulin	Balixafortide: Balixafortide + Eribulin
BG001	Eribulin Monotherapy	Eribulin: Eribulin alone
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Balixafortide + Eribulin	Balixafortide: Balixafortide + Eribulin	17	218	62	218	214	218
EG001	Eribulin Monotherapy	Eribulin: Eribulin alone	13	204	54	204	197	204