A Trial of Preoperative MM-121 With Paclitaxel in HER2-ne... | NCT01421472

NCT01421472

Status Module

Sponsor/Collaborators Module

Name	Class
Sanofi	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MM-121 (SAR256212) + paclitaxel	Experimental	2 week run-in of MM-121 followed by MM-121 + dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	Drug: MM-121 Drug: Paclitaxel
Paclitaxel only	Active Comparator	Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	Drug: Paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MM-121	Drug	MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses	MM-121 (SAR256212) + paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)	Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.	At time of surgery, an expected average of 24-26 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Victor Moyo, MD	Merrimack Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Universito of Birmingham atAlabama		Birmingham	Alabama	35294	United States
Arizona Oncology Associates

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	HR+: MM-121+ Paclitaxel	Hormone-receptor positive (HR+) sub-group randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)

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

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	HR+: MM-121+ Paclitaxel	Hormone-receptor positive (HR+) sub-group randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)
BG001	HR+: Paclitaxel Only	Hormone-receptor positive (HR+) sub-group randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
BG002	TN: MM-121 + Paclitaxel	Triple Negative (TN) patients randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)
BG003	TN: Paclitaxel	Triple negative (TN) patients randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00050.7± 10.35 BG00148.9± 10.53 BG00249.3± 10.89 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00067 BG00133 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00010 BG00110 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00067 BG00133 BG002

Subject of Child-Bearing Potential (Y/N)

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG00032 BG00119 BG002

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

Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)

Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.

Subjects with evaluable resection.

Posted

Number

participants

At time of surgery, an expected average of 24-26 weeks

ID	Title	Description
OG000	HR+: MM-121+ Paclitaxel	Hormone-receptor positive (HR+) sub-group randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)
OG001	HR+: Paclitaxel Only	Hormone-receptor positive (HR+) sub-group randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
OG002	TN: MM-121 + Paclitaxel	Triple Negative (TN) patients randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)
OG003	TN: Paclitaxel	Triple negative (TN) patients randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.

Units	Counts
Participants	OG00066 OG00130 OG00256 OG003

Title

Denominators

Categories

Subjects with no pCR

Title	Measurements
	OG00059 OG00129 OG00232 OG003

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HR+: MM-121+ Paclitaxel	Hormone-receptor positive (HR+) sub-group randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	14	67	67	67
EG001	HR+: Paclitaxel Only	Hormone-receptor positive (HR+) sub-group randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	5	33	33	33
EG002	TN: MM-121 + Paclitaxel	Triple Negative (TN) patients randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	18	64	64	64
EG003	TN: Paclitaxel	Triple negative (TN) patients randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	5	32	32	32

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0010 affected33 at risk EG0026 affected64 at risk EG0032 affected32 at risk
Anemia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0010 affected33 at risk EG0024 affected64 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0023 affected64 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Bacteremia	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Breast Cellulutis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Cellulitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Clostridial Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Infected Cyst	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Infective Thrombosis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Influenza	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Lung Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Pneumonia	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Sepsis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Staphylococcal Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Hyperkalemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Hypovolemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0023 affected64 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Hypertension	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Hypotension	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Jugular Vein Thrombosis	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Pyrexia	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected33 at risk EG0021 affected64 at risk EG003
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Presyncope	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Syncope	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Sinus Tachycardia	Cardiac disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Electrocardiogram QT Prolonged	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00052 affected67 at risk EG00124 affected33 at risk EG00248 affected64 at risk EG00324 affected32 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00055 affected67 at risk EG00112 affected33 at risk EG00256 affected64 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00012 affected67 at risk EG00113 affected33 at risk EG00227 affected64 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00016 affected67 at risk EG00110 affected33 at risk EG00217 affected64 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00013 affected67 at risk EG0018 affected33 at risk EG00218 affected64 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00016 affected67 at risk EG0012 affected33 at risk EG00220 affected64 at risk EG003
Gastroesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00013 affected67 at risk EG0014 affected33 at risk EG00211 affected64 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0014 affected33 at risk EG00210 affected64 at risk EG003
Oral Pain	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00010 affected67 at risk EG0012 affected33 at risk EG0028 affected64 at risk EG003
Hemorrhoids	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 affected67 at risk EG0010 affected33 at risk EG0029 affected64 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0013 affected33 at risk EG0022 affected64 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0011 affected33 at risk EG0022 affected64 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0025 affected64 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0012 affected33 at risk EG0022 affected64 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0011 affected33 at risk EG0022 affected64 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0012 affected33 at risk EG0022 affected64 at risk EG003
Mouth Ulceration	Gastrointestinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0010 affected33 at risk EG0022 affected64 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG00042 affected67 at risk EG00122 affected33 at risk EG00242 affected64 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG00028 affected67 at risk EG0015 affected33 at risk EG00227 affected64 at risk EG003
Nail Disorder	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0009 affected67 at risk EG0013 affected33 at risk EG00216 affected64 at risk EG003
Pruritis	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0015 affected33 at risk EG0029 affected64 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0009 affected67 at risk EG0011 affected33 at risk EG00210 affected64 at risk EG003
Nail Discoloration	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG00011 affected67 at risk EG0012 affected33 at risk EG0026 affected64 at risk EG003
Skin Hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 affected67 at risk EG0012 affected33 at risk EG0026 affected64 at risk EG003
Rash Maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 affected67 at risk EG0011 affected33 at risk EG0024 affected64 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0011 affected33 at risk EG0023 affected64 at risk EG003
Skin Discoloration	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0012 affected33 at risk EG0022 affected64 at risk EG003
Palmar-Plantar Erythrodysasthesia Syndrome	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0010 affected33 at risk EG0024 affected64 at risk EG003
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0010 affected33 at risk EG0023 affected64 at risk EG003
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0011 affected33 at risk EG0022 affected64 at risk EG003
Pain of Skin	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0010 affected33 at risk EG0022 affected64 at risk EG003
Nail Bed Tenderness	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0012 affected33 at risk EG0021 affected64 at risk EG003
Rash Macular	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0023 affected64 at risk EG003
Dermatitis Acneform	Skin and subcutaneous tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Fatigue	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG00054 affected67 at risk EG00121 affected33 at risk EG00250 affected64 at risk EG003
Mucosal Inflammation	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG00017 affected67 at risk EG0015 affected33 at risk EG00211 affected64 at risk EG003
Pyrexia	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG00017 affected67 at risk EG0018 affected33 at risk EG0028 affected64 at risk EG003
Peripheral edema	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG00010 affected67 at risk EG0019 affected33 at risk EG00211 affected64 at risk EG003
Pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0013 affected33 at risk EG0028 affected64 at risk EG003
Asthenia	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0012 affected33 at risk EG0024 affected64 at risk EG003
Chills	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected33 at risk EG0025 affected64 at risk EG003
Chest Pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0010 affected33 at risk EG0024 affected64 at risk EG003
Catheter Site Pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0012 affected33 at risk EG0023 affected64 at risk EG003
Chest Discomfort	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0012 affected33 at risk EG0021 affected64 at risk EG003
Non-cardiac Chest Pain	General disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Peripheral neuropathy	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG00032 affected67 at risk EG00117 affected33 at risk EG00237 affected64 at risk EG003
Headache	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG00019 affected67 at risk EG00113 affected33 at risk EG00210 affected64 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG00014 affected67 at risk EG0018 affected33 at risk EG00220 affected64 at risk EG003
Dizziness	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG00011 affected67 at risk EG0016 affected33 at risk EG00210 affected64 at risk EG003
Peripheral sensory neuropathy9	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0008 affected67 at risk EG0015 affected33 at risk EG0029 affected64 at risk EG003
Parasthesia	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0014 affected33 at risk EG0026 affected64 at risk EG003
Hypoasthesia	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0012 affected33 at risk EG0025 affected64 at risk EG003
Syncope	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0011 affected33 at risk EG0022 affected64 at risk EG003
Restless leg syndrome	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0011 affected33 at risk EG0021 affected64 at risk EG003
Hyperasthesia	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0012 affected33 at risk EG0021 affected64 at risk EG003
Sinus Headache	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0022 affected64 at risk EG003
Disturbance in Attention	Nervous system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG00012 affected67 at risk EG0014 affected33 at risk EG00211 affected64 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG00011 affected67 at risk EG0012 affected33 at risk EG00211 affected64 at risk EG003
Sinusitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0010 affected33 at risk EG0026 affected64 at risk EG003
Folliculitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0013 affected33 at risk EG0024 affected64 at risk EG003
Oral Herpes	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0010 affected33 at risk EG0025 affected64 at risk EG003
Oral Candidiasis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0013 affected33 at risk EG0024 affected64 at risk EG003
Fungal Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected33 at risk EG0024 affected64 at risk EG003
Vulvovaginal Mycotic Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0024 affected64 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0014 affected33 at risk EG0022 affected64 at risk EG003
Nail Infection	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0012 affected33 at risk EG0022 affected64 at risk EG003
Candidiasis	Infections and infestations	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG00011 affected67 at risk EG0018 affected33 at risk EG00214 affected64 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG00014 affected67 at risk EG0018 affected33 at risk EG00211 affected64 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG00011 affected67 at risk EG0012 affected33 at risk EG00211 affected64 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG00010 affected67 at risk EG0012 affected33 at risk EG0027 affected64 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 affected67 at risk EG0015 affected33 at risk EG0027 affected64 at risk EG003
Muscle Spasm	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0011 affected33 at risk EG0026 affected64 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0012 affected33 at risk EG0025 affected64 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0013 affected33 at risk EG0021 affected64 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00018 affected67 at risk EG0015 affected33 at risk EG00219 affected64 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG00018 affected67 at risk EG0014 affected33 at risk EG00220 affected64 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0019 affected33 at risk EG0025 affected64 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0014 affected33 at risk EG0028 affected64 at risk EG003
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0015 affected33 at risk EG0023 affected64 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0010 affected33 at risk EG0024 affected64 at risk EG003
Dyspnea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0011 affected33 at risk EG0024 affected64 at risk EG003
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Nasal Dryness	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0024 affected64 at risk EG003
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0013 affected33 at risk EG0020 affected64 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG00018 affected67 at risk EG0017 affected33 at risk EG00217 affected64 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG00021 affected67 at risk EG0013 affected33 at risk EG0029 affected64 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG00010 affected67 at risk EG0014 affected33 at risk EG00211 affected64 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG00011 affected67 at risk EG0013 affected33 at risk EG0027 affected64 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0011 affected33 at risk EG0027 affected64 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0011 affected33 at risk EG0024 affected64 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0010 affected33 at risk EG0022 affected64 at risk EG003
Anemia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG00032 affected67 at risk EG00113 affected33 at risk EG00224 affected64 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG00021 affected67 at risk EG0019 affected33 at risk EG00218 affected64 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0008 affected67 at risk EG0012 affected33 at risk EG0027 affected64 at risk EG003
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0011 affected33 at risk EG0028 affected64 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Weight Decreased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG00019 affected67 at risk EG0015 affected33 at risk EG00217 affected64 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0012 affected33 at risk EG0024 affected64 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA (13.1)	Non-systematic Assessment	EG0005 affected67 at risk EG0012 affected33 at risk EG0024 affected64 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (13.1)	Non-systematic Assessment	EG00021 affected67 at risk EG00110 affected33 at risk EG00220 affected64 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (13.1)	Non-systematic Assessment	EG00010 affected67 at risk EG0013 affected33 at risk EG0026 affected64 at risk EG003
Depression	Psychiatric disorders	MedDRA (13.1)	Non-systematic Assessment	EG0008 affected67 at risk EG0014 affected33 at risk EG0024 affected64 at risk EG003
Agitation	Psychiatric disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0012 affected33 at risk EG0020 affected64 at risk EG003
Hot Flush	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG00010 affected67 at risk EG0016 affected33 at risk EG0028 affected64 at risk EG003
Hypotension	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 affected67 at risk EG0012 affected33 at risk EG0025 affected64 at risk EG003
Hypertension	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0013 affected33 at risk EG0023 affected64 at risk EG003
Flushing	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0010 affected33 at risk EG0023 affected64 at risk EG003
Lymphoedema	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0024 affected64 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0012 affected33 at risk EG0020 affected64 at risk EG003
Jugular Vein Thrombosis	Vascular disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0012 affected33 at risk EG0020 affected64 at risk EG003
Vision Blurred	Eye disorders	MedDRA (13.1)	Non-systematic Assessment	EG0008 affected67 at risk EG0014 affected33 at risk EG0028 affected64 at risk EG003
Dry Eye	Eye disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0012 affected33 at risk EG0020 affected64 at risk EG003
Lacrimatino Increased	Eye disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0012 affected33 at risk EG0023 affected64 at risk EG003
Conjunctivitis	Eye disorders	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0012 affected33 at risk EG0021 affected64 at risk EG003
Infusion Related Reaction	Injury, poisoning and procedural complications	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0013 affected33 at risk EG0026 affected64 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	MedDRA (13.1)	Non-systematic Assessment	EG0003 affected67 at risk EG0012 affected33 at risk EG0023 affected64 at risk EG003
Breast Pain	Reproductive system and breast disorders	MedDRA (13.1)	Non-systematic Assessment	EG0006 affected67 at risk EG0010 affected33 at risk EG0025 affected64 at risk EG003
Vaginal Hemorrhage	Reproductive system and breast disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0011 affected33 at risk EG0024 affected64 at risk EG003
Vulvovaginal Dryness	Reproductive system and breast disorders	MedDRA (13.1)	Non-systematic Assessment	EG0001 affected67 at risk EG0010 affected33 at risk EG0022 affected64 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0007 affected67 at risk EG0012 affected33 at risk EG0028 affected64 at risk EG003
Pollakuria	Renal and urinary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0011 affected33 at risk EG0022 affected64 at risk EG003
Urinary Incontinence	Renal and urinary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0002 affected67 at risk EG0011 affected33 at risk EG0020 affected64 at risk EG003
Nocturia	Renal and urinary disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0020 affected64 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0011 affected33 at risk EG0026 affected64 at risk EG003
Palpitations	Cardiac disorders	MedDRA (13.1)	Non-systematic Assessment	EG0004 affected67 at risk EG0011 affected33 at risk EG0023 affected64 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0022 affected64 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA (13.1)	Non-systematic Assessment	EG0000 affected67 at risk EG0010 affected33 at risk EG0021 affected64 at risk EG003

ID	Term
D001943	Breast Neoplasms

ID	Term
C000589319	seribantumab
D017239	Paclitaxel

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

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