A Study of Liposomal Doxorubicin With or Without Olaratum... | NCT00913835

ID	Type	Description
2009-009035-30	EudraCT Number
CP15-0802	Other Identifier	ImClone Systems
I5B-IE-JGDA	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Olaratumab and Liposomal Doxorubicin	Experimental	Olaratumab and Liposomal Doxorubicin	Biological: Olaratumab Drug: liposomal doxorubicin
Liposomal Doxorubicin: Optional Olaratumab Monotherapy	Active Comparator	Liposomal Doxorubicin Monotherapy until disease progression. Upon disease progression the participant had the option to receive Olaratumab monotherapy.	Biological: Olaratumab Drug: liposomal doxorubicin

Name	Type	Description	Arm Group Labels	Other Names
Olaratumab	Biological	20 milligrams per kilogram (mg/kg) administered by intervenous (IV) infusion every 2 weeks (14 days). Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.	Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.	First Day of Therapy to Date of Death (Up to 35 Months)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant has histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer, or ovarian clear cell carcinoma
The participant must have at least one of the following: a platinum-free interval of ≤12 months after the final dose of primary or subsequent platinum-based therapy (platinum-resistant), progression during primary or subsequent platinum-based therapy (platinum-refractory), or persistent radiographic disease after primary or subsequent platinum-based therapy (platinum-refractory)
The participant has a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction (LVEF) ≥50%, within 21 days prior to randomization
The participant has at least one unidimensionally measurable target lesion [≥20 millimeters (mm) with conventional techniques, or ≥10 mm by spiral computed tomography (CT) or magnetic resonance imaging (MRI)], as defined by Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST v1.0) guidelines. Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
The participant has recovered to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to ≤Grade 2). The exceptions for such effects are allowed lab values of ≤Grade 2 specified elsewhere in these inclusion criteria
The participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1 at study entry
The participant has the ability to understand and the willingness to sign a written informed consent
The participant has adequate hematological functions [absolute neutrophil count (ANC) ≥1200 cells/microliter (cells/μL), hemoglobin ≥9 grams/deciliter (g/dL), and platelets ≥100,000 cells/μL]
The participant has adequate hepatic function as defined by total bilirubin ≤1.5 × the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 × the ULN (or ≤5 × the ULN in the presence of known liver metastases)
The participant has adequate renal function as defined by serum creatinine ≤1.5 × the institutional ULN. If creatinine is above the ULN, the participant's creatinine clearance is ≥60 milliliters/minute (mL/min)
The participant has urinary protein ≤1+ on dipstick or routine urinalysis; if urine dipstick or routine analysis is ≥2+, a 24-hour urine for protein must demonstrate <1000 milligrams (mg) of protein to allow participation
The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤1.5 and a partial thromboplastin time (PTT) ≤5seconds above ULN. Participants on anticoagulation must be on a stable dose of anticoagulant with a therapeutic INR and no active bleeding within 14 days prior to randomization, or on low molecular weight heparin AND have no pathological condition carrying a high risk of bleeding. Mild elevations of PTT of up to 1.5 × the ULN are acceptable, provided that, in the opinion of the investigator, they are related to ongoing use of coumarins [for example (e.g.), warfarin]
The participant has a pre-study echocardiogram or MUGA scan with an actual LVEF ≥50%, within 21 days prior to randomization
Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization and for the duration of study participation

Exclusion Criteria:

The participant has brain metastases or leptomeningeal disease
The participant received more than one biologic and/or more than one hormonal therapy, administered either concomitantly with platinum-based therapy or separately
The participant has a history of treatment with other agents targeting platelet derived growth factor (PDGF) or PDGF receptor (PDGFR)
The participant has an increased level of cancer antigen-125 (CA-125) in the absence of concomitant clinical or radiographic progression
The participant has received radiotherapy, chemotherapy, or biologic therapy directed at the malignant tumor within 3 weeks prior to randomization, or hormonal therapy directed at the malignant tumor within 1 week prior to randomization. Continuation of hormone replacement therapy is permitted
The participant has a suspected impending bowel obstruction (including partial obstruction), based on clinical or radiographic data
The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of IMC-3G3
The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure,uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
The participant has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years prior to randomization
The participant is pregnant or lactating
The participant has ongoing side effects ≥Grade 2 due to agents administered more than 28 days prior to randomization. The exceptions for such effects are allowed lab values and toxicities of ≤Grade 2, specified in the inclusion criteria
The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months prior to randomization
The participant has participated in clinical trials of experimental agents within 28 days prior to randomization
The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
The participant has a serious or nonhealing active wound, ulcer, or bone fracture
The participant has known human immunodeficiency virus positivity
The participant had a major surgical procedure, an open biopsy, or significant traumatic injury within 28 days prior to randomization
The participant has received an anthracycline for any indication in the past

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
ImClone Investigational Site		Joliet	Illinois	60435	United States
ImClone Investigational Site

PubMed Identifier	Type	Citation	Retractions
37185961	Derived	Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
30591028	Derived	McGuire WP, Penson RT, Gore M, Herraez AC, Peterson P, Shahir A, Ilaria R Jr. Randomized phase II study of the PDGFRalpha antibody olaratumab plus liposomal doxorubicin versus liposomal doxorubicin alone in patients with platinum-refractory or platinum-resistant advanced ovarian cancer. BMC Cancer. 2018 Dec 27;18(1):1292. doi: 10.1186/s12885-018-5198-4.

ID	Title	Description
FG000	Olaratumab + Liposomal Doxorubicin	20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity. 40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.

ID	Title	Description
BG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
BG001	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00062 BG00161 BG002123

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS)

PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.

Modified Intent to Treat (mITT) Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=13, Liposomal Doxorubicin=14.

Posted

Median

90% Confidence Interval

weeks

Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.

Units	Counts
Participants	OG00062 OG00161

Title

Denominators

Categories

Title	Measurements
	OG00018.1(8.7 to 27.0) OG00117.3(14.1 to 31.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.	0.8049		Hazard Ratio (HR)	1.054			2-Sided	90	0.751	1.478					Superiority or Other (legacy)

Secondary

Overall Survival (OS)

OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.

mITT Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=21, Liposomal Doxorubicin=23.

Posted

Median

90% Confidence Interval

weeks

First Day of Therapy to Date of Death (Up to 35 Months)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.

Secondary

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

The percentage of participants with a best overall response of confirmed CR or PR defined using RECIST v1.0 criteria. CR is the disappearance of all target and non-target lesions and normalization of cancer antigen-125 (CA-125) levels. PR is defined as having a ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. The percentage of participants with objective response was calculated as: (number of participants whose best overall response of CR or PR/number of participants treated) * 100.

mITT Population: All randomized participants who received any amount of study drug.

Posted

Number

90% Confidence Interval

percentage of participants

Randomization to PD (Up to 35 Months)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.

Secondary

Median Duration of Response

Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.0 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is a ≥30% decrease in the sum of the LD of target lesions without new lesions and progression of non-target lesions. PD is a ≥20% increase in the sum of the LD of target lesions and/or unequivocal progression of existing non-target lesions and/or detection of 1 or more new lesions. Participants who did not relapse were censored on the day of their last tumor assessment.

All participants who achieved CR or PR. Participants censored: Olaratumab=2, Liposomal Doxorubicin=4.

Posted

Median

90% Confidence Interval

weeks

Date of Initial CR or PR to PD (Up to 35 Months)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.

Secondary

Number of Participants With Adverse Events (AEs) and Who Died

Reported are the number of participants with clinically significant events, defined as serious AEs (SAEs) and other non-serious AEs regardless of causality and those who died during treatment and during the 30-day post-dose follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module of this report.

All randomized participants who received any amount of study drug.

Posted

Number

participants

Baseline Up to End of Treatment and 30-day Post-dose Follow-up (Up to 35 Months)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy..

Secondary

Percentage of Participants With Anti-Olaratumab Antibodies

Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.

All randomized participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.

Posted

Number

percentage of participants

Baseline Up to 30-Day Postdose Follow-Up (Up To 35 Months)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.

Secondary

PFS of Participants Who Received Olaratumab After Liposomal Doxorubicin Monotherapy (Descriptive Statistics for Safety and Efficacy for Participants Who Continue on Olaratumab Monotherapy Following Disease Progression on Liposomal Doxorubicin Monotherapy)

PFS is defined as the time from start of Olaratumab monotherapy to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.

Participants who received Olaratumab treatment after PD on liposomal doxorubicin monotherapy. Participants censored=4

Posted

Median

90% Confidence Interval

weeks

From Start of Olaratumab Monotherapy to PD or Date of Death (Up to 20 Weeks)

ID	Title	Description
OG000	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.

Secondary

Area Under the Curve (AUC) of Olaratumab

Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.

Posted

Prior to and 1 Hour (h) After Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.
OG002	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.

Secondary

Maximum Concentration (Cmax) of Olaratumab

Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.

Posted

Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.
OG002	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.

Secondary

Half-life (t1/2) of Olaratumab

The time it takes to reduce the concentration of Olaratumab in the plasma by 50%.

Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.

Posted

Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.
OG002	Liposomal Doxorubicin: Optional Olaratumab Monotherapy

Secondary

Clearance (CL) of Olaratumab

CL is the volume of serum cleared of Olaratumab per unit of time after a single dose of Olaratumab

Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.

Posted

Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.
OG002	Liposomal Doxorubicin: Optional Olaratumab Monotherapy

Secondary

Apparent Volume of Distribution (Vss) of Olaratumab

Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.

Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.

Posted

Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
OG001	Liposomal Doxorubicin	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.
OG002	Liposomal Doxorubicin: Optional Olaratumab Treatment

Secondary

PFS for Participants Who Had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association Between PDGFRα Tumor Expression and PFS)

PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment. PDGFRα protein expression at baseline in tumor cells is determined by IHC using H-Scores and a cut point of 0. Participants were considered to have a high relative expression when H-Score is >0 and a low relative expression when H-Score=0. H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining. Staining intensity: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from 0-300.

All participants who had evaluable PDGFRα results.

Posted

Median

95% Confidence Interval

weeks

Randomization to PD or Date of Death (Up to 130 Weeks)

ID	Title	Description
OG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events1 affected61 at risk EG0021 events1 affected28 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events2 affected62 at risk EG0012 events2 affected61 at risk EG0020 events0 affected28 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0013 events3 affected61 at risk EG0021 events1 affected28 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0014 events3 affected61 at risk EG0020 events0 affected28 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0012 events2 affected61 at risk EG0020 events0 affected28 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Ileus	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events2 affected61 at risk EG0020 events0 affected28 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected62 at risk EG0013 events2 affected61 at risk EG0021 events1 affected28 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected61 at risk EG0022 events2 affected28 at risk
Proctitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0014 events4 affected61 at risk EG0020 events0 affected28 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected62 at risk EG0013 events3 affected61 at risk EG0022 events2 affected28 at risk
Chills	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Disease progression	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Extravasation	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Infusion site erythema	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected62 at risk EG0010 events0 affected61 at risk EG0022 events2 affected28 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Hypersensitivity	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Bacillus infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Cellulitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Device related infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Febrile infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Pharyngitis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events2 affected61 at risk EG0020 events0 affected28 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Urosepsis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Viral infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0012 events1 affected61 at risk EG0020 events0 affected28 at risk
Incorrect drug administration duration	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Medication error	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Syncope	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Bradyphrenia	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected61 at risk EG0021 events1 affected28 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected62 at risk EG0014 events4 affected61 at risk EG0020 events0 affected28 at risk
Venous thrombosis	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00021 events10 affected62 at risk EG00123 events13 affected61 at risk EG0028 events6 affected28 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00010 events6 affected62 at risk EG0012 events2 affected61 at risk EG0020 events0 affected28 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00067 events16 affected62 at risk EG00123 events8 affected61 at risk EG0023 events2 affected28 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0013 events3 affected61 at risk EG0022 events2 affected28 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00018 events14 affected62 at risk EG0018 events6 affected61 at risk EG0025 events5 affected28 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00022 events15 affected62 at risk EG00135 events25 affected61 at risk EG0023 events3 affected28 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected62 at risk EG0016 events5 affected61 at risk EG0023 events2 affected28 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00011 events10 affected62 at risk EG0018 events7 affected61 at risk EG0023 events2 affected28 at risk
Ascites	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00017 events12 affected62 at risk EG0019 events6 affected61 at risk EG0026 events5 affected28 at risk
Constipation	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00040 events32 affected62 at risk EG00133 events24 affected61 at risk EG0028 events7 affected28 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00028 events19 affected62 at risk EG00116 events13 affected61 at risk EG0025 events5 affected28 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00014 events8 affected62 at risk EG0017 events7 affected61 at risk EG0027 events7 affected28 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected62 at risk EG0015 events3 affected61 at risk EG0020 events0 affected28 at risk
Flatulence	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected62 at risk EG0015 events4 affected61 at risk EG0020 events0 affected28 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected62 at risk EG0017 events6 affected61 at risk EG0021 events1 affected28 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00061 events35 affected62 at risk EG00161 events39 affected61 at risk EG00216 events13 affected28 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected62 at risk EG0014 events4 affected61 at risk EG0020 events0 affected28 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00040 events23 affected62 at risk EG00134 events16 affected61 at risk EG0022 events2 affected28 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00041 events21 affected62 at risk EG00133 events18 affected61 at risk EG00212 events10 affected28 at risk
Asthenia	General disorders	MedDRA 14.1	Systematic Assessment	EG00011 events8 affected62 at risk EG00121 events11 affected61 at risk EG0026 events4 affected28 at risk
Early satiety	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected62 at risk EG0014 events4 affected61 at risk EG0020 events0 affected28 at risk
Fatigue	General disorders	MedDRA 14.1	Systematic Assessment	EG00064 events33 affected62 at risk EG00150 events27 affected61 at risk EG0026 events5 affected28 at risk
Mucosal inflammation	General disorders	MedDRA 14.1	Systematic Assessment	EG00019 events12 affected62 at risk EG00138 events15 affected61 at risk EG0023 events2 affected28 at risk
Oedema peripheral	General disorders	MedDRA 14.1	Systematic Assessment	EG00013 events10 affected62 at risk EG00116 events12 affected61 at risk EG0023 events3 affected28 at risk
Pyrexia	General disorders	MedDRA 14.1	Systematic Assessment	EG00015 events8 affected62 at risk EG0017 events7 affected61 at risk EG0023 events3 affected28 at risk
Candidiasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Oral candidiasis	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events2 affected62 at risk EG0013 events2 affected61 at risk EG0022 events2 affected28 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events3 affected62 at risk EG0015 events4 affected61 at risk EG0022 events2 affected28 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00023 events15 affected62 at risk EG0015 events3 affected61 at risk EG0023 events3 affected28 at risk
Haemoglobin decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0008 events7 affected62 at risk EG0014 events4 affected61 at risk EG0023 events2 affected28 at risk
Neutrophil count decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG0006 events3 affected62 at risk EG0015 events5 affected61 at risk EG0020 events0 affected28 at risk
Weight decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG00010 events9 affected62 at risk EG0014 events4 affected61 at risk EG0021 events1 affected28 at risk
White blood cell count decreased	Investigations	MedDRA 14.1	Systematic Assessment	EG00027 events6 affected62 at risk EG0013 events3 affected61 at risk EG0020 events0 affected28 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00031 events15 affected62 at risk EG00119 events13 affected61 at risk EG00210 events10 affected28 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected62 at risk EG0012 events2 affected61 at risk EG0021 events1 affected28 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0015 events4 affected61 at risk EG0020 events0 affected28 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0008 events5 affected62 at risk EG0018 events7 affected61 at risk EG0025 events4 affected28 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00015 events8 affected62 at risk EG0018 events6 affected61 at risk EG0023 events2 affected28 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00013 events11 affected62 at risk EG0018 events7 affected61 at risk EG0021 events1 affected28 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00018 events16 affected62 at risk EG00112 events9 affected61 at risk EG0026 events5 affected28 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00014 events7 affected62 at risk EG0013 events3 affected61 at risk EG0023 events3 affected28 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected62 at risk EG0010 events0 affected61 at risk EG0021 events1 affected28 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected62 at risk EG0019 events9 affected61 at risk EG0022 events1 affected28 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00012 events10 affected62 at risk EG00113 events10 affected61 at risk EG0021 events1 affected28 at risk
Dysgeusia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00012 events10 affected62 at risk EG0016 events3 affected61 at risk EG0020 events0 affected28 at risk
Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00018 events12 affected62 at risk EG0018 events7 affected61 at risk EG0027 events6 affected28 at risk
Lethargy	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00010 events6 affected62 at risk EG0016 events4 affected61 at risk EG0020 events0 affected28 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0006 events5 affected62 at risk EG0014 events2 affected61 at risk EG0020 events0 affected28 at risk
Paraesthesia	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0004 events3 affected62 at risk EG0017 events6 affected61 at risk EG0020 events0 affected28 at risk
Tremor	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected62 at risk EG0010 events0 affected61 at risk EG0020 events0 affected28 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected62 at risk EG0016 events6 affected61 at risk EG0020 events0 affected28 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected62 at risk EG0013 events3 affected61 at risk EG0021 events1 affected28 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected62 at risk EG0011 events1 affected61 at risk EG0023 events2 affected28 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected62 at risk EG0012 events2 affected61 at risk EG0020 events0 affected28 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00010 events7 affected62 at risk EG0012 events2 affected61 at risk EG0021 events1 affected28 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0022 events2 affected28 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected62 at risk EG0017 events7 affected61 at risk EG0022 events2 affected28 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00011 events10 affected62 at risk EG00112 events10 affected61 at risk EG0024 events4 affected28 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected62 at risk EG0014 events3 affected61 at risk EG0020 events0 affected28 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00011 events6 affected62 at risk EG0014 events4 affected61 at risk EG0023 events2 affected28 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00011 events10 affected62 at risk EG00110 events9 affected61 at risk EG0021 events1 affected28 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00011 events7 affected62 at risk EG00111 events7 affected61 at risk EG0021 events1 affected28 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00011 events8 affected62 at risk EG00111 events10 affected61 at risk EG0020 events0 affected28 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected62 at risk EG00110 events8 affected61 at risk EG0020 events0 affected28 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected62 at risk EG0010 events0 affected61 at risk EG0022 events2 affected28 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00054 events21 affected62 at risk EG00160 events27 affected61 at risk EG0022 events1 affected28 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected62 at risk EG0015 events5 affected61 at risk EG0021 events1 affected28 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG00037 events24 affected62 at risk EG00134 events14 affected61 at risk EG0025 events4 affected28 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected62 at risk EG0012 events2 affected61 at risk EG0020 events0 affected28 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 events3 affected62 at risk EG00111 events6 affected61 at risk EG0020 events0 affected28 at risk
Flushing	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk
Hypertension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected62 at risk EG0013 events3 affected61 at risk EG0021 events1 affected28 at risk
Hypotension	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected62 at risk EG0011 events1 affected61 at risk EG0020 events0 affected28 at risk

ID	Term
D010051	Ovarian Neoplasms
D009369	Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Olaratumab and Liposomal Doxorubicin	20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.	27	62	62	62
EG001	Liposomal Doxorubicin	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.	23	61	60	61
EG002	Liposomal Doxorubicin: Optional Olaratumab Monotherapy	40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.	14	28	27	28