Phase I/II Study of U3-1402 in Subjects With Human Epider... | NCT02980341

ID	Type	Description	Link
JapicCTI-163401	Registry Identifier	JapicCTI

Name	Class
Daiichi Sankyo	INDUSTRY
Merck Sharp & Dohme LLC	INDUSTRY

Label	Type	Description	Intervention Names
Dose Escalation Part	Experimental	Participants receive U3-1402 from 1.6 mg/kg to 8.0 mg/kg, administered via intravenous (IV) solution at 3-week intervals.	Drug: Patritumab Deruxtecan
Dose Finding Part	Experimental	Participants receive 1 of 5 different U3-1402 dosing regimens, administered via IV solution at 2 or 3-week intervals at doses at or lower than those studied in the Dose Escalation Part.	Drug: Patritumab Deruxtecan
Dose Expansion Part	Experimental	Participants with HER3 high, HER2 negative, HR positive status receive 4.8 mg/kg or 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 low, HER2 negative, HR positive status receive 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 high, HER2 negative, HR negative status receive 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.	Drug: Patritumab Deruxtecan

Name	Type	Description	Arm Group Labels	Other Names
Patritumab Deruxtecan	Drug	U3-1402 consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a)

Measure	Description	Time Frame
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)	AEs will be collected systematically from signing of the informed consent form (ICF) through 28 days after last dose	Baseline up to 28 days post last dose, up to approximately 9 months
Number of Participants With Best Overall Tumor Response Using Blinded Independent Central Review Based on Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1	CR was defined as a disappearance of all target and non-target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target and non-target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target and non-target lesions. Objective response rate is the number of patients with confirmed complete response and confirmed partial response.	From screening until disease progresses, up to approximately 9 months

Measure	Description	Time Frame
Dose Escalation Part: Area Under the Serum Concentration Time Curve (AUC) of Anti-HER3-ac-DXd	The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.	Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)
Dose Finding Part: AUC of Anti-HER3-ac-DXd

Name	Affiliation	Role
Global Clinical Leader	Daiichi Sankyo	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southeastern Regional Medical Center		Newnan	Georgia	30265	United States
Northwestern University

PubMed Identifier	Type	Citation	Retractions
37801674	Derived	Krop IE, Masuda N, Mukohara T, Takahashi S, Nakayama T, Inoue K, Iwata H, Yamamoto Y, Alvarez RH, Toyama T, Takahashi M, Osaki A, Saji S, Sagara Y, O'Shaughnessy J, Ohwada S, Koyama K, Inoue T, Li L, Patel P, Mostillo J, Tanaka Y, Sternberg DW, Sellami D, Yonemori K. Patritumab Deruxtecan (HER3-DXd), a Human Epidermal Growth Factor Receptor 3-Directed Antibody-Drug Conjugate, in Patients With Previously Treated Human Epidermal Growth Factor Receptor 3-Expressing Metastatic Breast Cancer: A Multicenter, Phase I/II Trial. J Clin Oncol. 2023 Dec 20;41(36):5550-5560. doi: 10.1200/JCO.23.00882. Epub 2023 Oct 6.

ID	Title	Description
FG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
FG001	Dose Escalation: Cohort 3.2 mg/kg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 8, 2022

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 Reporting Treatment-emergent Adverse Events (TEAEs)

AEs will be collected systematically from signing of the informed consent form (ICF) through 28 days after last dose

Adverse events are reported from the Safety Analysis Set.

Posted

Count of Participants

Participants

Baseline up to 28 days post last dose, up to approximately 9 months

ID	Title	Description
OG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG003	Dose Escalation/Dose Finding: Cohort 6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG004	Dose Escalation: Cohort 8.0 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG005	Dose Finding: 3.2/4.8/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
OG006	Dose Finding: 4.2/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
OG007	Dose Expansion: HER3 High 4.8 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG008	Dose Expansion: HER3-High 6.4 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG009	Dose Expansion: HER3-Low 6.4 mg/kg	Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG010	Dose Expansion: TNBC 6.4 mg/kg	Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.

Units	Counts
Participants	OG0003 OG0013 OG00215 OG003

Title

Denominators

Categories

Any TEAE

Title	Measurements
	OG0003 OG0013 OG00215 OG003

Primary

Number of Participants With Best Overall Tumor Response Using Blinded Independent Central Review Based on Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

CR was defined as a disappearance of all target and non-target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target and non-target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target and non-target lesions. Objective response rate is the number of patients with confirmed complete response and confirmed partial response.

Best overall tumor response was assessed in the Full Analysis Set.

Posted

Count of Participants

Participants

From screening until disease progresses, up to approximately 9 months

ID	Title	Description
OG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg

Secondary

Dose Escalation Part: Area Under the Serum Concentration Time Curve (AUC) of Anti-HER3-ac-DXd

The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ng*d/mL

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG003	Dose Escalation/Dose Finding: Cohort 6.4 mg/kg

Secondary

Dose Finding Part: AUC of Anti-HER3-ac-DXd

The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ng*d/mL

Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Finding: 3.2/4.8/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
OG001	Dose Finding: 4.2/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).

Units	Counts
Participants	OG000

Secondary

Dose Expansion Part: AUC of Anti-HER3-ac-DXd

The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ng*d/mL

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Expansion: HER3 High 4.8 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG001	Dose Expansion: HER3-High 6.4 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG002	Dose Expansion: HER3-Low 6.4 mg/kg	Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG003	Dose Expansion: TNBC 6.4 mg/kg

Secondary

Dose Escalation Part: Maximum Plasma Concentration (Cmax) of Anti-HER3-ac-DXd

The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed using the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG003	Dose Escalation/Dose Finding: Cohort 6.4 mg/kg

Secondary

Dose Finding Part: Cmax of Anti-HER3-ac-DXd

The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Finding: 3.2/4.8/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
OG001	Dose Finding: 4.2/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).

Units	Counts
Participants	OG000

Secondary

Dose Expansion Part: Cmax of Anti-HER3-ac-DXd

The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set

Posted

Mean

Standard Deviation

ng/mL

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Expansion: HER3 High 4.8 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG001	Dose Expansion: HER3-High 6.4 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG002	Dose Expansion: HER3-Low 6.4 mg/kg	Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG003	Dose Expansion: TNBC 6.4 mg/kg

Secondary

Dose Escalation Part: Time to Maximum Plasma Concentration (Tmax) of Anti-HER3-ac-DXd

The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in the Pharmacokinetic Analysis Set.

Posted

Median

Full Range

hours

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG003	Dose Escalation/Dose Finding: Cohort 6.4 mg/kg

Secondary

Dose Finding Part: Tmax of Anti-HER3-ac-DXd

The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Median

Full Range

hours

Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Finding: 3.2/4.8/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
OG001	Dose Finding: 4.2/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).

Units	Counts
Participants	OG000

Secondary

Dose Expansion Part: Tmax of Anti-HER3-ac-DXd

The serum concentrations for anti-HER3-ac-DXd were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Median

Full Range

hours

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Expansion: HER3 High 4.8 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG001	Dose Expansion: HER3-High 6.4 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG002	Dose Expansion: HER3-Low 6.4 mg/kg	Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG003	Dose Expansion: TNBC 6.4 mg/kg

Secondary

Dose Escalation Part: Area Under the Concentration-Time Curve of Total Anti-HER3 Antibody

The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ug*d/mL

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG003	Dose Escalation/Dose Finding: Cohort 6.4 mg/kg

Secondary

Dose Finding Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody

The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ug*d/mL

Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Finding: 3.2/4.8/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
OG001	Dose Finding: 4.2/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).

Units	Counts
Participants	OG000

Secondary

Dose Expansion Part: Area Under the Concentration-Time Curve in Total Anti-HER3 Antibody

The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ug*d/mL

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Expansion: HER3 High 4.8 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG001	Dose Expansion: HER3-High 6.4 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG002	Dose Expansion: HER3-Low 6.4 mg/kg	Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG003

Secondary

Dose Escalation Part: Cmax of Total Anti-HER3 Antibody

The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.

Pharmacokinetic data were assessed in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ug/mL

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG003	Dose Escalation/Dose Finding: Cohort 6.4 mg/kg

Secondary

Dose Finding Part: Cmax of Anti-HER3 Antibody

The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ug/mL

Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Finding: 3.2/4.8/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
OG001	Dose Finding: 4.2/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).

Units	Counts
Participants	OG000

Secondary

Dose Expansion Part: Cmax in Anti-HER3 Antibody

The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.

Pharmacokinetic data were assessed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Mean

Standard Deviation

ug/mL

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Expansion: HER3 High 4.8 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG001	Dose Expansion: HER3-High 6.4 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG002	Dose Expansion: HER3-Low 6.4 mg/kg	Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG003	Dose Expansion: TNBC 6.4 mg/kg

Secondary

Dose Escalation Part: Tmax of Total Anti-HER3 Antibody

The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.

Pharmacokinetic data were assessed in the Pharmacokinetic Analysis Set.

Posted

Median

Full Range

hours

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
OG003	Dose Escalation/Dose Finding: Cohort 6.4 mg/kg

Secondary

Dose Finding Part: Tmax of Anti-HER3 Antibody

The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.

Pharmacokinetic data were analyzed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Median

Full Range

hours

Cycle 1, Day 1 to Cycle 4, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Finding: 3.2/4.8/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
OG001	Dose Finding: 4.2/6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).

Units	Counts
Participants	OG000

Secondary

Dose Expansion Part: Tmax in Anti-HER3 Antibody

The serum concentrations for total anti-HER3 antibody LC/MS were quantified using the IC-LC/MS assay.

Pharmacokinetic data were assessed in participants with available data in the Pharmacokinetic Analysis Set.

Posted

Median

Full Range

hours

Cycle 1, Day 1 to Cycle 3, Day 21 (each cycle is 21 days)

ID	Title	Description
OG000	Dose Expansion: HER3 High 4.8 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG001	Dose Expansion: HER3-High 6.4 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG002	Dose Expansion: HER3-Low 6.4 mg/kg	Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
OG003	Dose Expansion: TNBC 6.4 mg/kg

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG0030 affected15 at risk EG0040 affected6 at risk EG0051 affected12 at risk EG0060 affected12 at risk EG0070 affected33 at risk EG0080 affected31 at risk EG0090 affected21 at risk EG0101 affected31 at risk
Cellulitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Implant site infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Malaise	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Platelet count decreased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Delirum	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hypotension	Vascular disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Superior vena cava syndrome	Vascular disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Disease progression	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Fatigue	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Asthenia	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pyrexia	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Troponin increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Cataract	Eye disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Venoocclusive liver disease	Hepatobiliary disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0026 affected15 at risk EG0034 affected15 at risk EG0040 affected6 at risk EG0053 affected12 at risk EG0063 affected12 at risk EG0075 affected33 at risk EG0083 affected31 at risk EG0095 affected21 at risk EG0103 affected31 at risk
Cystitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Paronychia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Influenza	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pneumonia	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Cellulitis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Tinea pedis	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Otitis externa	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Implant site infection	Infections and infestations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0028 affected15 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Iodine allergy	Immune system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Allergy to arthropod sting	Immune system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Cushingoid	Endocrine disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG0029 affected15 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0023 affected15 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0024 affected15 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Agitation	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Headache	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0023 affected15 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected15 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0022 affected15 at risk EG003
Taste disorder	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Somnolence	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Akathisia	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Parkinsonism	Nervous system disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Dry eye	Eye disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Conjunctivitis allergic	Eye disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Keratitis	Eye disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Punctate keratitis	Eye disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Conjunctival deposit	Eye disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Strabismus	Eye disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Embolism	Vascular disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected15 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected15 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected15 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0002 affected3 at risk EG0013 affected3 at risk EG00211 affected15 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0002 affected3 at risk EG0012 affected3 at risk EG0028 affected15 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0025 affected15 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0013 affected3 at risk EG0026 affected15 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0023 affected15 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Angular cheilitis	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected15 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected15 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0021 affected15 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0011 affected3 at risk EG0022 affected15 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected15 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Skin sensitisation	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pubic pain	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Menstruation irregular	Reproductive system and breast disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Fatigue	General disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0025 affected15 at risk EG003
Malaise	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0022 affected15 at risk EG003
Pyrexia	General disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0022 affected15 at risk EG003
Oedema peripheral	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Pain	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected15 at risk EG003
Mucosal inflammation	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Oedema	General disorders	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Performance status decreased	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Platelet count decreased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG00210 affected15 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG00210 affected15 at risk EG003
White blood cell count decreased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0029 affected15 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG00210 affected15 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0029 affected15 at risk EG003
Weight decreased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0023 affected15 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0022 affected15 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Ejection fraction decreased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Blood creatinine phosphokinase increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Blood pressure increased	Investigations	MedDRA 24	Systematic Assessment	EG0001 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Eosinophil count increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Intraocular pressure increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0021 affected15 at risk EG003
Blood electrolytes decreased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0021 affected15 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Foreign body in eye	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0011 affected3 at risk EG0020 affected15 at risk EG003
Radiation fibrosis - lung	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Depression	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Delirium	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Visual impairment	Eye disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Palpitations	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hypotension	Vascular disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Lymphoedema	Vascular disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hyperaesthesia teeth	Gastrointestinal disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Vulvovaginal dryness	Reproductive system and breast disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Chills	General disorders	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Blood creatinine increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Weight increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Troponin T increased	Investigations	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Rash pustular	Infections and infestations	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Confusional state	Psychiatric disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Cataract	Eye disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Corneal disorder	Eye disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Venoocclusive liver disease	Hepatobiliary disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Onychomadesis	Skin and subcutaneous tissue disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Peripheral sweling	General disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Infusion site extravasation	General disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Feeling abnormal	General disorders	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA Ver 24	Systematic Assessment	EG0000 affected3 at risk EG0010 affected3 at risk EG0020 affected15 at risk EG003

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

ID	Title	Description
BG000	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.
BG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.
BG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.
BG003	Dose Escalation/Dose Finding: Cohort 6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.
BG004	Dose Escalation: Cohort 8.0 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.
BG005	Dose Finding: 3.2/4.8/6.4 mg/kg	Participants who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).
BG006	Dose Finding: 4.2/6.4 mg/kg	Participants who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).
BG007	Dose Expansion: HER3 High 4.8 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
BG008	Dose Expansion: HER3-High 6.4 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
BG009	Dose Expansion: HER3-Low 6.4 mg/kg	Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
BG010	Dose Expansion: TNBC 6.4 mg/kg	Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
BG011	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	Dose Escalation: Cohort 1.6 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 1.6 mg/kg administered via intravenous (IV) solution at 3-week intervals.	2	3	1	3	3	3
EG001	Dose Escalation: Cohort 3.2 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 3.2 mg/kg administered via intravenous (IV) solution at 3-week intervals.	2	3	1	3	3	3
EG002	Dose Escalation/Dose Finding: Cohort 4.8 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 4.8 mg/kg administered via intravenous (IV) solution at 3-week intervals.	13	15	3	15	15	15
EG003	Dose Escalation/Dose Finding: Cohort 6.4 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 6.4 mg/kg administered via intravenous (IV) solution at 3-week intervals.	11	15	9	15	15	15
EG004	Dose Escalation: Cohort 8.0 mg/kg	Participants with HER3-positive metastatic breast cancer who received U3-1402 8.0 mg/kg administered via intravenous (IV) solution at 3-week intervals.	2	6	2	6	6	6
EG005	Dose Finding: 3.2/4.8/6.4 mg/kg	Participants who received U3-1402 (Cycle 1: 3.2 mg/kg IV infusion Q3W; Cycle 2: 4.8 mg/kg IV infusion Q3W; Cycle 3 and all subsequent cycles: 6.4 mg/kg IV infusion Q3W).	10	12	4	12	12	12
EG006	Dose Finding: 4.2/6.4 mg/kg	Participants who received U3-1402 (Cycles 1-3: 4.2 mg/kg IV infusion Q3W; Subsequent cycles: 6.4 mg/kg IV infusion Q3W).	10	12	3	12	12	12
EG007	Dose Expansion: HER3 High 4.8 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 4.8 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.	22	33	10	33	32	33
EG008	Dose Expansion: HER3-High 6.4 mg/kg	Participants with HER3-high, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.	24	31	12	31	31	31
EG009	Dose Expansion: HER3-Low 6.4 mg/kg	Participants with HER3-low, HER2-negative, HR-positive breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.	18	21	7	21	21	21
EG010	Dose Expansion: TNBC 6.4 mg/kg	Participants with HER3-High, triple negative breast cancer who received 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.	16	31	8	31	31	31