A Study of Paclitaxel/Carboplatin With or Without Olaratu... | NCT00918203

ID	Type	Description	Link
CP15-0804	Other Identifier	ImClone Systems
I5B-IE-JGDB	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Paclitaxel + Carboplatin	Active Comparator	(Initial 4-6 cycles) Paclitaxel 200 milligram/square meter (mg/m2) over 3 hrs (Day 1) Carboplatin Area Under Concentration (AUC)=6 (Day 1) of each 21-day cycle (Initial 4-6 cycles) Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle Participants who experience progressive disease may cross over to olaratumab monotherapy.	Drug: Paclitaxel Drug: Carboplatin
Olaratumab + Paclitaxel + Carboplatin	Experimental	(Initial 4-6 cycles) Olaratumab 15 milligrams/kilogram (mg/kg) over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.	Biological: Olaratumab Drug: Paclitaxel Drug: Carboplatin

Name	Type	Description	Arm Group Labels	Other Names
Olaratumab	Biological	15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered intravenously (IV) at 25 milligram/minute (mg/min), with a minimum infusion time of 30 minutes.

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 by RECIST version 1.1, or death from any cause. Participants who died without a reported prior 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 their last tumor assessment. If there was no radiologic assessment at baseline or post baseline, participants were censored at the date of randomization. If death or progressive disease (PD) occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.	Baseline to Measured PD or Death From Any Cause (Up to 31 Months)

Measure	Description	Time Frame
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)	A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.	Baseline to Study Completion (Up to 43 Months)
Safety and Tolerability of Olaratumab Administered at a More Rapid Rate (25mg/Min With Minimum Infusion Time of 30 Minutes), Determined by Number of Participants With Treatment Related Adverse Events

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participants has histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC)Stage IIIB with effusion. Mixed Non-Small Cell Lung Cancer (NSCLC) tumors will be categorized by the predominant cell type. Primary or metastatic site may be used for histology
For squamous cell histology or for centrally located mediastinal masses (< 3 cm from the carina) identified by computed tomography scan (CT) or chest x-ray, the participant must undergo a magnetic resonance imaging (MRI) of the chest or I.V. contrast CT scan within 3 weeks of randomization, to exclude major airway or blood vessel invasion (in the investigator's opinion) by cancer
The participant has measurable disease (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's Eastern Cooperative Oncology Group (ECOG) performance status is 0-1
The participant's age at the time of study entry is ≥ 18 years
The participant has adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9.5 g/dL, and a platelet count ≥ 100,000/μL obtained within 2 weeks prior to randomization
The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 × the upper limit of normal (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 patient's creatinine clearance (CrCl) is ≥ 60 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 < 1 g of protein in 24 hours to allow participation
The participant has adequate coagulation function, as defined by international normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, have therapeutic INR, no active bleeding (defined as within 14 days randomization) and no pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels or known varices)
Because the teratogenicity of Olaratumab is not known, women of childbearing potential (WOCBP) and sexually active males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization and for the duration of study participation
The participant has resolution to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4 (NCI-CTCAE v 4.02) of all clinically significant toxic effects of prior locoregional therapy, surgery, chemoembolization, or other anticancer therapy. The exceptions for such effects are events that pertain to the lab values found elsewhere in these inclusion criteria. (For example, criterion # 6 states that a patient with hemoglobin ≥ 9.5 g/dL is considered eligible, even though NCI-CTCAE v 4.02 defines this value as Grade 2 anemia.)
The participant has a life expectancy of ≥ 3 months
The participant has provided signed informed consent

Exclusion Criteria:

The participant has untreated central nervous system (CNS) metastases. Participants are eligible if they are clinically stable, off all steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, stereotactic radiosurgery)ending at least 2 weeks prior to randomization, or after surgical resection performed at least 4 weeks prior to randomization
The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer, or of intratumor cavitation
The participant received prior systemic chemotherapy or biologic therapy (eg erlotinib) for Stage IIIB/IV NSCLC outside of the adjuvant setting. Participants who received prior cytotoxic chemotherapy or biologic therapy in the adjuvant setting will not be excluded based on such therapy
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 c)other primary solid tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years prior to randomization
The participant is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent
The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
The participant has an uncontrolled thrombotic or hemorrhagic disorder
The participant has a history of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon) within 2 months of randomization
The participant has a serious non-healing wound, ulcer, or bone fracture within 28 days prior to randomization
The participant has undergone major surgery within 28 days prior to randomization
The participant has received adjuvant chemotherapy 21 days prior to randomization or has participated in clinical trials of experimental agents within 28 days prior to randomization
The participant has an elective or a planned major surgery to be performed during the course of the trial
The participant has peripheral neuropathy ≥ Grade 2 NCI-CTCAE v 4.02
The participant has known human immunodeficiency virus (HIV) positivity
The participant, if female, is pregnant or lactating
The participant has received previous therapy with any agent that targets platelet derived growth factor (PDGF) or platelet derived growth factor receptor (PDGFR)
The participant has a known allergy to any of the treatment components
The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of Olaratumab

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		Birmingham	Alabama	35294	United States
ImClone Investigational Site

ID	Title	Description
FG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel 200 milligram/square meter (mg/m2) over 3 hrs (Day 1) Carboplatin Area Under Concentration (AUC)=6 (Day 1) of each 21-day cycle Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle Participants who experience progressive disease may cross over to olaratumab monotherapy. Paclitaxel: 200 mg/m2 is then administered intravenously (IV) over 3 hours carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

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 by RECIST version 1.1, or death from any cause. Participants who died without a reported prior 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 their last tumor assessment. If there was no radiologic assessment at baseline or post baseline, participants were censored at the date of randomization. If death or progressive disease (PD) occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.

All randomized participants who received any dose of study drug. Participants censored: paclitaxel + carboplatin = 13, olaratumab + paclitaxel + carboplatin = 20, and crossover to olaratumab = 4. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.

Posted

Median

95% Confidence Interval

weeks

Baseline to Measured PD or Death From Any Cause (Up to 31 Months)

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of Olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
OG001	Paclitaxel + Carboplatin	Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
OG002	Crossover to Olaratumab	Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.

Units	Counts
Participants	OG00067 OG00164 OG00217

Title

Denominators

Categories

Title	Measurements
	OG00019.1(16.4 to 23.6) OG00119.0(15.3 to 25) OG0028.3(5.0 to 13.4)

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 OG002		Log Rank		0.2133		Hazard Ratio (HR)	1.29			2-Sided	95	0.86	1.93					Superiority or Other

Secondary

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

All randomized participants who received any dose of study drug. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.

Posted

Number

participants

Baseline to Study Completion (Up to 43 Months)

ID	Title	Description
OG000	Olaratumab + Pacilitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
OG001	Paclitaxel + Carboplatin	Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
OG002

Secondary

Safety and Tolerability of Olaratumab Administered at a More Rapid Rate (25mg/Min With Minimum Infusion Time of 30 Minutes), Determined by Number of Participants With Treatment Related Adverse Events

All randomized participants who received any dose of study drug. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.

Posted

Number

participants

Up to 43 Months

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
OG001	Paclitaxel + Carboplatin	Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
OG002	Crossover to Olaratumab

Secondary

Overall Survival (OS)

Overall survival is defined as the time from date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS was censored on the last date the participants is known to be alive.

All randomized participants who received any dose of study drug. OS data was not analyzed in the crossover olaratumab arm. Participants censored: olaratumab + paclitaxel + carboplatin = 19 and paclitaxel + carboplatin = 20.

Posted

Median

95% Confidence Interval

weeks

Baseline to Death From Any Cause (Up to 31 Months)

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
OG001	Paclitaxel + Carboplatin	Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

Secondary

Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)

The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.

All randomized participants who received any dose of study drug. 1 participant did not cross over to Olaratumab until after efficacy data completion, no efficacy data collected on this participant.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Measured PD or Study Discontinuation (Up to 31 Months)

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

Secondary

Median Duration of Response

The duration of overall response is measured from the time measurement criteria are first met for Complete Response (CR)/Partial Response (PR) (whichever is first recorded) until the first date that the criteria for PD are met (taking as a reference for PD the smallest measurement recorded since the treatment started), initiation of other/additional antitumor therapy is first reported, or death, is objectively documented.

All randomized participants who received any dose of study drug and had achieved tumor response of CR or PR. Median Duration of Response data was not analyzed in the crossover olaratumab arm.

Posted

Median

95% Confidence Interval

weeks

First Criteria Met for CR or PR to Measured PD Start of Other Antitumor Therapy or Death From Any Cause (Up to 31 Months)

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
OG001	Paclitaxel + Carboplatin	Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

Secondary

Pharmacodynamics of Olaratumab

Pharmacodynamics of Olaratumab was determined by analysis of pharmacodynamic markers vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF).

No data was available due to the collection of plasma samples was not fit for the assessment of PDGFs, as the collection procedure did not prevent platelet activation resulting in elevated levels of PDGFs in the circulation. Pharmacodynamics data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.

Posted

Cycle 1: Days 1, 8, and 15 pre- and post-infusion of Olaratumab; Cycles 2-6: day 1 only, pre- and post-infusion of Olaratumab

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

Units	Counts
Participants

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 had baseline and post baseline Anti-Olaratumab antibodies. Those participants who did not meet eligibility criteria were not included in this assessment.

Posted

Number

percentage of participants

Baseline to Study Completion (Up to 8 Months)

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
OG001	Crossover to Olaratumab	Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.

Secondary

Pharmacokinetics (PK) - Area Under the Curve (AUC) 0-168 of Olaratumab

AUC(0-168) = area under the concentration versus time curve from time zero to 168 hours post dose.

All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram*hour/milliliter (ug*hr/mL)

Cycle 3, Day 1: Predose, 30 minutes (min), 1.5 hours (hrs), 24,48,96,168 Hrs Post Dose

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

Units	Counts
Participants	OG000

Secondary

PK - Maximum Concentration (Cmax) of Olaratumab

All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/milliliter (ug/mL)

Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

Units	Counts
Participants	OG000

Secondary

PK - Half-Life (t1/2) of Olaratumab

Posted

Geometric Mean

Full Range

days

Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25 mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

Units	Counts
Participants	OG000

Secondary

PK - Clearance (Cl) of Olaratumab

All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter/hour (L/h)

Cycle 3, Day 1: Predose, 30 min, 1.5 hr, 24,48,96,168 Hrs Post Dose

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

Units	Counts
Participants	OG000

Secondary

PK - Steady State Volume of Distribution (Vss) of Olaratumab

All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.

Posted

Geometric Mean

Geometric Coefficient of Variation

Liter (L)

Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose

ID	Title	Description
OG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0012 events2 affected64 at risk EG0020 events0 affected18 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Atrial flutter	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Influenza like illness	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Infusion related reaction	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Non-cardiac chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Abscess intestinal	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Device related infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Diverticulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Eye infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0014 events4 affected64 at risk EG0020 events0 affected18 at risk
Pneumonia viral	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Wound infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Incorrect drug administration duration	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0012 events2 affected64 at risk EG0020 events0 affected18 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Confusional state	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Mental status changes	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0020 events0 affected18 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0004 events3 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected67 at risk EG0014 events4 affected64 at risk EG0020 events0 affected18 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00045 events23 affected67 at risk EG00141 events26 affected64 at risk EG0023 events2 affected18 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00032 events15 affected67 at risk EG00119 events6 affected64 at risk EG0020 events0 affected18 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00019 events8 affected67 at risk EG0016 events4 affected64 at risk EG0020 events0 affected18 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00067 events29 affected67 at risk EG00139 events18 affected64 at risk EG0020 events0 affected18 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG00064 events29 affected67 at risk EG00132 events15 affected64 at risk EG0020 events0 affected18 at risk
Vision blurred	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0006 events5 affected67 at risk EG0012 events2 affected64 at risk EG0020 events0 affected18 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0012 events2 affected64 at risk EG0021 events1 affected18 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0008 events4 affected67 at risk EG0017 events4 affected64 at risk EG0020 events0 affected18 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0007 events6 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00029 events24 affected67 at risk EG00129 events27 affected64 at risk EG0021 events1 affected18 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00047 events29 affected67 at risk EG00126 events19 affected64 at risk EG0020 events0 affected18 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00014 events11 affected67 at risk EG0019 events7 affected64 at risk EG0020 events0 affected18 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 events3 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00057 events34 affected67 at risk EG00147 events35 affected64 at risk EG0021 events1 affected18 at risk
Oral discomfort	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00016 events16 affected67 at risk EG0018 events8 affected64 at risk EG0020 events0 affected18 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00036 events28 affected67 at risk EG00130 events22 affected64 at risk EG0021 events1 affected18 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0005 events4 affected67 at risk EG0014 events4 affected64 at risk EG0020 events0 affected18 at risk
Chest discomfort	General disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0012 events2 affected64 at risk EG0020 events0 affected18 at risk
Chills	General disorders	MedDRA 12.0	Systematic Assessment	EG0008 events8 affected67 at risk EG0016 events6 affected64 at risk EG0021 events1 affected18 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG00075 events43 affected67 at risk EG00149 events33 affected64 at risk EG0024 events3 affected18 at risk
Infusion related reaction	General disorders	MedDRA 12.0	Systematic Assessment	EG0007 events6 affected67 at risk EG0011 events1 affected64 at risk EG0021 events1 affected18 at risk
Non-cardiac chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected67 at risk EG0012 events2 affected64 at risk EG0021 events1 affected18 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG00015 events12 affected67 at risk EG0015 events5 affected64 at risk EG0020 events0 affected18 at risk
Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0014 events4 affected64 at risk EG0021 events1 affected18 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0008 events6 affected67 at risk EG0018 events5 affected64 at risk EG0020 events0 affected18 at risk
Candidiasis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected64 at risk EG0021 events1 affected18 at risk
Soft tissue infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0011 events1 affected64 at risk EG0021 events1 affected18 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0008 events5 affected67 at risk EG0015 events5 affected64 at risk EG0022 events1 affected18 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0013 events1 affected64 at risk EG0022 events1 affected18 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Alanine aminotransferase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected67 at risk EG0014 events4 affected64 at risk EG0020 events0 affected18 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0021 events1 affected18 at risk
Blood phosphorus decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
International normalised ratio increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0021 events1 affected18 at risk
Platelet count decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0018 events5 affected64 at risk EG0020 events0 affected18 at risk
Weight decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected67 at risk EG00117 events12 affected64 at risk EG0022 events1 affected18 at risk
White blood cell count decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0013 events2 affected64 at risk EG0020 events0 affected18 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00035 events28 affected67 at risk EG00116 events12 affected64 at risk EG0020 events0 affected18 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0017 events6 affected64 at risk EG0021 events1 affected18 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00011 events10 affected67 at risk EG00115 events11 affected64 at risk EG0020 events0 affected18 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00010 events8 affected67 at risk EG0017 events5 affected64 at risk EG0021 events1 affected18 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0006 events6 affected67 at risk EG00114 events9 affected64 at risk EG0025 events2 affected18 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG00017 events13 affected67 at risk EG00113 events11 affected64 at risk EG0021 events1 affected18 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0012 events2 affected64 at risk EG0020 events0 affected18 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0006 events5 affected67 at risk EG0011 events1 affected64 at risk EG0022 events1 affected18 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG00043 events25 affected67 at risk EG00124 events14 affected64 at risk EG0022 events2 affected18 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG00012 events11 affected67 at risk EG00115 events12 affected64 at risk EG0021 events1 affected18 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0013 events3 affected64 at risk EG0020 events0 affected18 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 events1 affected67 at risk EG0017 events4 affected64 at risk EG0021 events1 affected18 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0005 events3 affected67 at risk EG0014 events4 affected64 at risk EG0021 events1 affected18 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0005 events5 affected67 at risk EG00111 events10 affected64 at risk EG0020 events0 affected18 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0006 events2 affected67 at risk EG0013 events3 affected64 at risk EG0022 events2 affected18 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG00018 events14 affected67 at risk EG00121 events15 affected64 at risk EG0020 events0 affected18 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0006 events6 affected67 at risk EG00120 events16 affected64 at risk EG0023 events3 affected18 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00017 events10 affected67 at risk EG00115 events13 affected64 at risk EG0023 events3 affected18 at risk
Dysgeusia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00013 events13 affected67 at risk EG00110 events9 affected64 at risk EG0021 events1 affected18 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00014 events13 affected67 at risk EG00114 events10 affected64 at risk EG0020 events0 affected18 at risk
Memory impairment	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00033 events23 affected67 at risk EG00129 events17 affected64 at risk EG0021 events1 affected18 at risk
Paraesthesia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0005 events4 affected67 at risk EG0015 events4 affected64 at risk EG0020 events0 affected18 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00039 events21 affected67 at risk EG00138 events22 affected64 at risk EG0021 events1 affected18 at risk
Somnolence	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0010 events0 affected64 at risk EG0021 events1 affected18 at risk
Anxiety	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0006 events5 affected67 at risk EG0016 events6 affected64 at risk EG0020 events0 affected18 at risk
Depression	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0012 events2 affected64 at risk EG0021 events1 affected18 at risk
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG00019 events14 affected67 at risk EG00112 events12 affected64 at risk EG0020 events0 affected18 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 12.0	Systematic Assessment	EG0002 events2 affected27 at risk EG0010 events0 affected30 at risk EG0020 events0 affected8 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0008 events7 affected67 at risk EG0019 events9 affected64 at risk EG0021 events1 affected18 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG00019 events18 affected67 at risk EG00116 events13 affected64 at risk EG0022 events2 affected18 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG00016 events11 affected67 at risk EG0019 events6 affected64 at risk EG0020 events0 affected18 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 events2 affected67 at risk EG0013 events3 affected64 at risk EG0021 events1 affected18 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0007 events7 affected67 at risk EG0011 events1 affected64 at risk EG0021 events1 affected18 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG00045 events37 affected67 at risk EG00140 events38 affected64 at risk EG0021 events1 affected18 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0007 events6 affected67 at risk EG0012 events2 affected64 at risk EG0020 events0 affected18 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0004 events4 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG00010 events8 affected67 at risk EG0013 events3 affected64 at risk EG0021 events1 affected18 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG00010 events6 affected67 at risk EG0019 events6 affected64 at risk EG0022 events1 affected18 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 events0 affected67 at risk EG0011 events1 affected64 at risk EG0021 events1 affected18 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 events1 affected67 at risk EG0011 events1 affected64 at risk EG0021 events1 affected18 at risk
Flushing	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0007 events6 affected67 at risk EG0011 events1 affected64 at risk EG0020 events0 affected18 at risk
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0005 events3 affected67 at risk EG0014 events4 affected64 at risk EG0020 events0 affected18 at risk

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D056831	Coordination Complexes

ID	Title	Description
BG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit. Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
BG001	Paclitaxel + Carboplatin	Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Olaratumab + Paclitaxel + Carboplatin	Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit. Olaratumab: 15 mg/kg of IMC-3G3 on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes. Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.	30	67	67	67
EG001	Paclitaxel + Carboplatin	Paclitaxel: 200 mg/m2 is then administered IV over 3 hours Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.	21	64	64	64
EG002	Crossover to Olaratumab	Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.	3	18	11	18