Study of MEDI-573 Plus Standard Endocrine Therapy for Wom... | NCT01446159

Label	Type	Description	Intervention Names
MEDI-573 10 mg/kg + AI	Experimental	Participants who will be enrolled in Phase 1b Cohort A of the study will receive intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.	Drug: MEDI-573 Drug: Aromatase Inhibitor
MEDI-573 30 mg/kg + AI	Experimental	Participants who will be enrolled in Phase 1b Cohort B of the study will receive intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.	Drug: MEDI-573 Drug: Aromatase Inhibitor
MEDI-573 45 mg/kg + AI	Experimental	Participants who will be enrolled in Phase 1b Cohort C and Phase 2 Arm 1 of the study will receive intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.	Drug: MEDI-573 Drug: Aromatase Inhibitor
Aromatase Inhibitor	Experimental	Participants who will be enrolled in Phase 2 Arm 2 of the study will receive oral AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Name	Type	Description	Arm Group Labels	Other Names
MEDI-573	Drug	Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Measure	Description	Time Frame
Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).	From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)	The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were >= Grade 3 in severity were considered as DLTs.	Up to Day 21 of Cycle 1
Phase 1b: Number of DLTs	The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were >= Grade 3 in severity were considered as DLTs.	Up to Day 21 of Cycle 1
Phase 2: Progression-free Survival (PFS)	Progression-free survival (PFS) was defined as the time from the randomization until the first documentation of disease progression or death due to any cause, whichever occurred first. The PFS was censored on the date of the last tumor assessment documenting absence of tumor progression for participants who had no documented progression and were still alive prior to data cut-off, dropout, or the initiation of alternate anticancer treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.

Measure	Description	Time Frame
Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs	An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).

Name	Affiliation	Role
MedImmune LLC	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Scottsdale	Arizona	85259	United States
Research Site

Label	URL
CD-ON-MEDI-573-1030-Protocol\_amendment 3\_redaction-PDF-A	View source
CD-ON-MEDI-573-1030-SAP-V1\_and\_V2\_Final\_Redacted\_PDF-A	View source

ID	Title	Description
FG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 25, 2016	Jun 6, 2018

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

Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).

Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.

Posted

Count of Participants

Participants

From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
OG003	Aromatase Inhibitor	Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Units	Counts
Participants	OG0003 OG0013 OG00292 OG003

Title

Denominators

Categories

Any TEAEs

Title	Measurements
	OG0003 OG0013 OG00290 OG003

Primary

Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)

The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were >= Grade 3 in severity were considered as DLTs.

Evaluable population included all participants in Phase 1b of the study, who received at least 1 full cycle of MEDI-573 and completed the safety follow-up through the DLT evaluation period (Days 1 to 21 of Cycle 1).

Posted

Count of Participants

Participants

Up to Day 21 of Cycle 1

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI

Primary

Phase 1b: Number of DLTs

The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were >= Grade 3 in severity were considered as DLTs.

Posted

Number

DLT events

Up to Day 21 of Cycle 1

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI

Primary

Phase 2: Progression-free Survival (PFS)

Progression-free survival (PFS) was defined as the time from the randomization until the first documentation of disease progression or death due to any cause, whichever occurred first.

The PFS was censored on the date of the last tumor assessment documenting absence of tumor progression for participants who had no documented progression and were still alive prior to data cut-off, dropout, or the initiation of alternate anticancer treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.

The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.

Posted

Median

95% Confidence Interval

Months

From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)

ID	Title	Description
OG000	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
OG001	Aromatase Inhibitor

Secondary

Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs

An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).

Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.

Posted

Count of Participants

Participants

From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI

Secondary

Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs

An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).

Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.

Posted

Count of Participants

Participants

From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Secondary

Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs

An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years).

Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received.

Posted

Count of Participants

Participants

From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 8 years)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Secondary

Phase 2: Number of Participants With Best Overall Tumor Response

Tumor evaluation was based on RECIST v1.1 by CT or MRI scan as: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion; not evaluable (NE): either no or only a subset of lesion measurements are made at an assessment.

The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.

Posted

Count of Participants

Participants

From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)

ID	Title	Description
OG000	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
OG001

Secondary

Phase 2: Objective Response Rate (ORR)

The ORR was defined as percentage of participants with confirmed complete response or confirmed partial response, where CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was definded as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.

The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.

Posted

Number

95% Confidence Interval

Percentage of participants

From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)

ID	Title	Description
OG000	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
OG001	Aromatase Inhibitor	Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Secondary

Phase 2: Time to Response

Time to response was measured from treatment start to the first documentation of disease response and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR. The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.

The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.

Posted

Median

Full Range

Months

From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)

ID	Title	Description
OG000	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
OG001	Aromatase Inhibitor	Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Secondary

Phase 2: Duration of Response (DR)

Duration of response (DR) is measured from the first documentation of disease response to the first documented progressive disease and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.

The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.

Posted

Median

Full Range

Months

From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)

ID	Title	Description
OG000	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
OG001	Aromatase Inhibitor	Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Secondary

Phase 2: Time to Progression (TTP)

Time to progression was measured from treatment start until the first documentation of disease progression. The PD was defined as >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.

The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.

Posted

Median

95% Confidence Interval

Months

From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)

ID	Title	Description
OG000	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
OG001	Aromatase Inhibitor	Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Secondary

Phase 2: Overall Survival (OS)

Overall survival (OS) was measured from treatment start until death.

The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.

Posted

Median

Full Range

Months

From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)

ID	Title	Description
OG000	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
OG001	Aromatase Inhibitor	Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Units	Counts
Participants

Secondary

Phase 2: Change in Tumor Size

Mean change in tumor size is reported.

The ITT population included all participants who received any study therapy and were analyzed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analyzed.

Posted

Mean

Standard Deviation

Centimeters

From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 8 years)

ID	Title	Description
OG000	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
OG001	Aromatase Inhibitor	Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.

Units	Counts
Participants

Secondary

Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1

AUC0-day21 of MEDI-573 for Cycle 1 is reported.

The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.

Posted

Mean

Standard Deviation

μg·day/mL

Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.

Secondary

Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1

AUC0-info of MEDI-573 for Cycle 1 is reported.

The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.

Posted

Mean

Standard Deviation

μg·day/mL

Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.

Secondary

Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1

DN AUC0-inf of MEDI-573 for Cycle 1 is reported.

The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.

Posted

Mean

Standard Deviation

day·kg·μg/mL/mg

Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.

Secondary

Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1

Cmax of MEDI-573 for Cycle 1 is reported.

The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.

Posted

Mean

Standard Deviation

μg/mL

Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.

Secondary

Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1

Tmax of MEDI-573 for Cycle 1 is reported.

The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.

Posted

Median

Full Range

Day

Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.

Secondary

Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1

The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by AUC(0-infinity).

The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.

Posted

Mean

Standard Deviation

mL/day/kg

Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI

Secondary

Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1

The elimination half-life (t1/2) is the time measured for the serum concentration of MEDI-573 to decrease by 1 half to its original concentration.

The ITT population was considered for this analysis. Participants who received MEDI-573 were analyzed.

Posted

Mean

Standard Deviation

Day

Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.

Secondary

Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II

The mean concentration profiles of both IGF-I and IGF-II post administration of MEDI-573 in plasma were evaluated during treatment.

Safety population included all participants who received any study therapy and were analyzed per the treatment they actually received. Participants with free IGF concentration were analyzed.

Posted

Mean

Standard Deviation

ng/mL

Baseline (Cycle1 Day1 pre-dose), end of treatment (EOT), and 60 days post last dose (Approximately 8 years)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI

Secondary

Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573

Participants With Positive ADA to MEDI-573 are reported.

Participants who received MEDI-573 and were analyzed per the treatment they actually received were analyzed for this outcome measure.

Posted

Count of Participants

Participants

Pre-infusion on Day 1 of each cycle, End of Treatment, Day 30, 60 and 90 post treatment (approximately 8 years)

ID	Title	Description
OG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
OG002	MEDI-573 45 mg/kg + AI

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG0030 events0 affected85 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Intestinal mass	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Wound infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events1 affected92 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0023 events3 affected92 at risk EG003
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Biliary dilatation	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events1 affected92 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Altered state of consciousness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Embolism	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG0031 events1 affected85 at risk
Palpitations	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected92 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0028 events7 affected92 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected3 at risk EG0010 events0 affected3 at risk EG00250 events30 affected92 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0027 events5 affected92 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0026 events6 affected92 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00211 events6 affected92 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00220 events14 affected92 at risk EG003
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG00233 events19 affected92 at risk EG003
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00216 events9 affected92 at risk EG003
Pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected92 at risk EG003
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00211 events9 affected92 at risk EG003
Swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected92 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected92 at risk EG003
Nail infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected92 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0024 events4 affected92 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00211 events9 affected92 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0027 events6 affected92 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0024 events3 affected92 at risk EG003
Gamma-glutamyltransferase decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0013 events1 affected3 at risk EG00241 events9 affected92 at risk EG003
Granulocyte count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Protein total decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG00210 events6 affected92 at risk EG003
Weight increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0025 events5 affected92 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0026 events5 affected92 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected3 at risk EG0010 events0 affected3 at risk EG00215 events7 affected92 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0029 events6 affected92 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG00249 events29 affected92 at risk EG003
Bone loss	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected3 at risk EG0010 events0 affected3 at risk EG0029 events9 affected92 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected3 at risk EG00212 events10 affected92 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0004 events2 affected3 at risk EG0011 events1 affected3 at risk EG00215 events12 affected92 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected3 at risk EG0013 events1 affected3 at risk EG00248 events17 affected92 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0006 events1 affected3 at risk EG0011 events1 affected3 at risk EG0026 events3 affected92 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events2 affected3 at risk EG0022 events1 affected92 at risk EG003
Dry eye	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0026 events5 affected92 at risk EG003
Photopsia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Vision blurred	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0029 events5 affected92 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0026 events5 affected92 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 events2 affected3 at risk EG0011 events1 affected3 at risk EG00227 events21 affected92 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0013 events2 affected3 at risk EG00253 events34 affected92 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected3 at risk EG0016 events3 affected3 at risk EG00296 events41 affected92 at risk EG003
Mucosal inflammation	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0029 events7 affected92 at risk EG003
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Lip infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG00248 events26 affected92 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG00213 events8 affected92 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0007 events2 affected3 at risk EG0011 events1 affected3 at risk EG00214 events6 affected92 at risk EG003
Blood albumin increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG00211 events5 affected92 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0023 events2 affected92 at risk EG003
Blood creatine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected92 at risk EG003
Blood creatinine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG00238 events8 affected92 at risk EG003
Blood magnesium decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Blood sodium decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0024 events1 affected92 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG00224 events19 affected92 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0022 events1 affected92 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0025 events3 affected92 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0015 events1 affected3 at risk EG00238 events10 affected92 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0025 events5 affected92 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected92 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00218 events10 affected92 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0005 events2 affected3 at risk EG0010 events0 affected3 at risk EG00216 events3 affected92 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 events1 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected92 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected3 at risk EG0011 events1 affected3 at risk EG00260 events28 affected92 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected92 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0022 events2 affected92 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG00213 events10 affected92 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0005 events2 affected3 at risk EG0011 events1 affected3 at risk EG00210 events9 affected92 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0027 events6 affected92 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00220 events14 affected92 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG00225 events16 affected92 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG00216 events13 affected92 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG00229 events20 affected92 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 events2 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected92 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG00213 events10 affected92 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected92 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG00212 events11 affected92 at risk EG003
Enuresis	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG00212 events10 affected92 at risk EG003
Tachyphrenia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Bladder spasm	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected92 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected92 at risk EG003
Breast haemorrhage	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected92 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0025 events4 affected92 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG00227 events19 affected92 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG00221 events18 affected92 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0027 events3 affected92 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0025 events5 affected92 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0027 events6 affected92 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00210 events8 affected92 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG0023 events1 affected92 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0023 events3 affected92 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG00215 events13 affected92 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00212 events11 affected92 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003
Hot flush	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG00222 events13 affected92 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG00217 events8 affected92 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected92 at risk EG003

ID	Term
D001943	Breast Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000601324	dusigitumab
D047072	Aromatase Inhibitors

ID	Term
D065088	Steroid Synthesis Inhibitors
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D004965	Estrogen Antagonists
D006727	Hormone Antagonists
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D045505	Physiological Effects of Drugs

ID	Title	Description
BG000	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
BG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
BG002	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.
BG003	Aromatase Inhibitor	Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
BG004	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	MEDI-573 10 mg/kg + Aromatase Inhibitor (AI)	Participants enrolled in Phase 1b of the study and received intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator's choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.	2	6	2	3	3	3
EG001	MEDI-573 30 mg/kg + AI	Participants enrolled in Phase 1 b of the study and received intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.	3	6	0	3	3	3
EG002	MEDI-573 45 mg/kg + AI	Participants received intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Three participants were enrolled in Phase 1b and 89 were enrolled in Phase 2 of the study.	43	184	21	92	86	92
EG003	Aromatase Inhibitor	Participants enrolled in Phase 2 of the study and received oral AI (letrozole, anastrozole, or exemestane) once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.	36	170	16	85	79	85