A Study of Olaratumab Alone and in Combination With Stand... | NCT02677116

NCT02677116

ID	Type	Description	Link
I5B-MC-JGDN	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Olaratumab + Doxorubicin (Part A)	Experimental	Cycle 1: Olaratumab 15 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	Drug: Olaratumab Drug: Doxorubicin
Olaratumab + Vincristine + Irinotecan (Part A)	Experimental	Cycle 1: Olaratumab 15 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	Drug: Olaratumab Drug: Vincristine Drug: Irinotecan
Olaratumab + Ifosfamide (Part A)	Experimental	Cycle 1: Olaratumab 15 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	Drug: Olaratumab Drug: Ifosfamide
Olaratumab + Doxorubicin (Part B)	Experimental	Cycle 1: Olaratumab 20 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Name	Type	Description	Arm Group Labels	Other Names
Olaratumab	Drug	Olaratumab administered IV.	Olaratumab + Doxorubicin (Part A) Olaratumab + Doxorubicin (Part B) Olaratumab + Doxorubicin (Part C)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)	A dose limiting toxicity (DLT) was defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of >14 days.	Parts A and B: Cycle 1 through Cycle 2 in each arm (21-day cycle); Part C: Cycle 1 only (21-day cycle)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Part A	Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.	Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
PK: Maximum Concentration (Cmax) of Olaratumab Part B

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant must have histological or cytological evidence of a diagnosis of solid tumor, excluding lymphomas and melanoma, but including central nervous system (CNS) tumors, that is relapsed or refractory, not be amenable to curative treatment.
The participant has the presence of measurable and/or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST Version 1.1). Response Assessment in Neuro-Oncology (RANO) Criteria or Macdonald Criteria should be used for CNS tumors.
The participant has a Lansky (<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50.
The participant has adequate hematologic, organ, and coagulation function ≤2 weeks (14 days) prior to first dose of study drug:
- Absolute neutrophil count (ANC) ≥750 cubic millimeters (mm³)
- Platelets ≥75,000/mm³
- Hemoglobin ≥8 grams per deciliter (g/dL)
- Total bilirubin (sum of conjugated + unconjugated) ≤1.5 x upper limit of normal (ULN) for age
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN
- Serum creatinine is based on age/gender
- Adequate coagulation function as defined by International Normalized Ratio ≤1.5 or prothrombin time ≤1.5 x ULN, and partial thromboplastin time ≤1.5 x ULN
Both female and male participants of child-bearing potential must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of olaratumab, or longer for other study drugs according to their label.
Participants must have fully recovered from the acute toxic effects of all prior anticancer therapies or must adhere to post-treatment conditions as follows:
- Myelosuppressive chemotherapy
- Hematopoietic growth factors
- Biologic (anti-neoplastic agent)
- Antibody therapy
- Radiation
- Stem cell infusion without traumatic brain injury
- Corticosteroids

Exclusion Criteria:

Have received treatment within 21 days of the initial dose of olaratumab with an investigational product or non-approved use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Participants that have had bone marrow or solid organ transplant are excluded.
The participant has an active fungal, bacterial, and/or known severe viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Female participants who are pregnant or breastfeeding are excluded.
If the participant is to be enrolled in the doxorubicin combination arm, a left ventricular dysfunction (LVEF < 50%) or shortening fraction of <27% by echocardiogram (either multigated acquisition [MUGA] or echocardiogram [ECHO] are required, not both).
Participants that have received prior anthracycline therapy if the participant is to be enrolled in the doxorubicin combination arm.

Contacts/Locations Module

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
Phoenix Childrens Hospital		Phoenix	Arizona	85016	United States
Childrens Hospital of Los Angeles

References Module

Label	URL
Click here for more information about this study: A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Olaratumab + Vincristine + Irinotecan (Part A)	Cycle 1: Olaratumab 15 milligram/kilogram (mg/kg) was administered alone intravenously (IV) on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 14, 2018	Nov 25, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Olaratumab + Ifosfamide (Part A)

Olaratumab + Ifosfamide (Part B)

Olaratumab + Ifosfamide (Part C)

Olaratumab + Vincristine + Irinotecan (Part A)

Olaratumab + Vincristine + Irinotecan (Part B)

Olaratumab + Vincristine + Irinotecan (Part C)

All participants who received at least one dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Olaratumab + Vincristine + Irinotecan (Part A)	Cycle 1: Olaratumab 15 milligram/kilogram (mg/kg) was administered alone intravenously (IV) on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
BG001	Olaratumab + Doxorubicin (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
BG002	Olaratumab + Ifosfamide (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
BG003	Olaratumab + Vincristine + Irinotecan (Part B)	Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
BG004	Olaratumab + Doxorubicin (Part B)	Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
BG005	Olaratumab + Ifosfamide (Part B)	Cycle1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
BG006	Olaratumab + Vincristine + Irinotecan (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
BG007	Olaratumab + Ifosfamide (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
BG008	Olaratumab + Doxorubicin (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
BG009	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0009.9± 5.5 BG0016.8± 4.3 BG00210.7± 4.3 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0004 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG0001 BG0014 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00010 BG00111 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)

A dose limiting toxicity (DLT) was defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of >14 days.

All participants who received at least one dose of study drug and had DLTs.

Posted

Count of Participants

Participants

Parts A and B: Cycle 1 through Cycle 2 in each arm (21-day cycle); Part C: Cycle 1 only (21-day cycle)

ID	Title	Description
OG000	Olaratumab + Vincristine + Irinotecan (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG001	Olaratumab + Ifosfamide (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG002	Olaratumab + Doxorubicin (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8). Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG003	Olaratumab + Vincristine + Irinotecan (Part B)	Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG004	Olaratumab + Ifosfamide (Part B)	Cycle 1: Olaratumab 20 mg/kg alone (administered IV on Days 1 and 8). Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG005	Olaratumab + Doxorubicin (Part B)	Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG006	Olaratumab + Vincristine + Irinotecan (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG007	Olaratumab + Ifosfamide (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG008	Olaratumab + Doxorubicin (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Units	Counts
Participants	OG00010 OG0019 OG00211 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Secondary

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Part A

Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.

All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1 Olaratumab alone and Cycle 2 Olaratumab combinations for Part A.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter (μg/mL)

Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose

ID	Title	Description
OG000	Olaratumab Alone (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. All cycles are 21 days.
OG001	Olaratumab + Doxorubicin (Part A)	Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG002	Olaratumab + Ifosfamide (Part A)	Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Secondary

PK: Maximum Concentration (Cmax) of Olaratumab Part B

PK: Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.

All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1 Olaratumab alone and Cycle 2 Olaratumab combinations for Part B. Zero participants analyzed for Olaratumab and Doxorubicin being below the quantifiable limit.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter (μg/mL)

Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose

ID	Title	Description
OG000	Olaratumab Alone (Part B)	Cycle 1: Olaratumab 20-mg/kg was administered alone IV on Days 1 and 8. All cycles are 21 days.
OG001	Olaratumab + Doxorubicin (Part B)	Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG002	Olaratumab + Ifosfamide (Part B)	Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Secondary

PK: Maximum Concentration (Cmax) of Olaratumab Part C

Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.

All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1 and 2 for all Part C treatment combinations. Per protocol, the Part C olaratumab alone was not collected.

Posted

Geometric Mean

Geometric Coefficient of Variation

microgram/milliliter (μg/mL)

Cycle 1, Days 1 and 8; Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose

ID	Title	Description
OG000	Olaratumab + Doxorubicin Cycle 1 (Part C)	Cycle 1: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG001	Olaratumab + Doxorubicin (Part C)	Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG002	Olaratumab + Vincristine + Irinotecan (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Secondary

PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part A

PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.

All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1 Olaratumab alone and Cycle 2 and 3-25 Olaratumab combinations for Part A.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose

ID	Title	Description
OG000	Olaratumab Alone (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. All cycles are 21 days.
OG001	Olaratumab + Doxorubicin (Part A)	Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG002	Olaratumab + Ifosfamide (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Secondary

PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part B

PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.

All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1, 2 and Cycle 3-25 Olaratumab combinations for Part B.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose

ID	Title	Description
OG000	Olaratumab Alone (Part B)	Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8. All cycles = 21 days
OG001	Olaratumab + Doxorubicin (Part B)	Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG002	Olaratumab + Ifosfamide (Part B)	Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Secondary

PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part C

PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.

All participants who had evaluable PK individual serum concentration samples analyzed for Cycle 1, 2 and Cycle 3-25 Olaratumab combinations for Part C.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose

ID	Title	Description
OG000	Olaratumab + Doxorubicin (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG001	Olaratumab + Vincristine + Irinotecan (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG002	Olaratumab + Ifosfamide (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Secondary

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

Objective Response Rate (ORR) is the percentage of participants achieving a confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions.

All participants who received at least one dose of study drug and had evaluable ORR data.

Posted

Number

percentage of participants

Baseline to objective progression or start of new anti-cancer therapy (Up to 7 months)

ID	Title	Description
OG000	Olaratumab + Vincristine + Irinotecan (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG001	Olaratumab + Ifosfamide (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Secondary

Progression Free Survival (PFS)

Progression-free survival (PFS) is defined as the time from baseline to the first date of radiological disease progression or death due to any cause. Progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression. If participant started new treatment before PD, the participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.

All participants who received at least one dose of study drug. Censored participants: Parts A-C include arms: Olaratumab + Vincristine + Irinotecan, Olaratumab + Ifosfamide and Olaratumab + Doxorubicin. Part A censored participants are 2, 2, and 2; Part B censored participants are 2, 2, and 1 and Part C censored participants are 2,1, and 4.

Posted

Median

95% Confidence Interval

Months

Baseline to radiological disease progression or death from any cause (Up to 2 Years)

ID	Title	Description
OG000	Olaratumab + Vincristine + Irinotecan (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.

Secondary

Percentage of Participants With Treatment Emergent (TE) Positive Anti-Olaratumab Antibodies

Percentage of participants with a TE positive anti-olaratumab antibodies defined as a participant with a 4-fold (2 dilutions) increase over a positive baseline antibody titer.

All participants who received at least one dose of study drug and had evaluable baseline sample and at least 1 evaluable post baseline sample.

Posted

Number

percentage of participants

From Baseline to Study Completion (Up to 33 Months)

ID	Title	Description
OG000	Olaratumab + Vincristine + Irinotecan (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG001	Olaratumab + Ifosfamide (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
OG002	Olaratumab + Doxorubicin (Part A)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Olaratumab + Vincristine + Irinotecan (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	2	10	3	10	10	10
EG001	Olaratumab + Ifosfamide (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	1	9	4	9	9	9
EG002	Olaratumab + Doxorubicin (Part A)	Cycle 1: Olaratumab 15 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	2	11	2	11	11	11
EG003	Olaratumab + Vincristine + Irinotecan (Part B)	Cycle 1: Olaratumab 20 mg/kg administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	2	10	5	10	9	10
EG004	Olaratumab + Ifosfamide (Part B)	Cycle 1: Olaratumab 20 mg/kg was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	2	13	7	13	13	13
EG005	Olaratumab + Doxorubicin (Part B)	Cycle 1: Olaratumab 20 mg/kg alone was administered alone IV on Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	0	1	0	1	1	1
EG006	Olaratumab + Vincristine + Irinotecan (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	0	6	2	6	6	6
EG007	Olaratumab + Ifosfamide (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	0	4	1	4	4	4
EG008	Olaratumab + Doxorubicin (Part C)	Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.	0	4	4	4	4	4

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0013 events2 affected9 at risk EG0020 events0 affected11 at risk EG0030 events0 affected10 at risk EG0040 events0 affected13 at risk EG0050 events0 affected1 at risk EG0060 events0 affected6 at risk EG0070 events0 affected4 at risk EG0080 events0 affected4 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Methaemoglobinaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Abdominal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Lung infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Penile infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected7 at risk EG0020 events0 affected8 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Shunt occlusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0014 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0013 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0013 events1 affected9 at risk EG0021 events1 affected11 at risk EG003
Staphylococcus test positive	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0013 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Vena cava thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0009 events4 affected10 at risk EG00136 events7 affected9 at risk EG00211 events6 affected11 at risk EG00318 events5 affected10 at risk EG00455 events8 affected13 at risk EG0050 events0 affected1 at risk EG00612 events4 affected6 at risk EG0075 events3 affected4 at risk EG00811 events4 affected4 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0007 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0008 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG00016 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0008 events2 affected10 at risk EG0012 events1 affected9 at risk EG0027 events1 affected11 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Otorrhoea	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Dry eye	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Eye pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Eye swelling	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Lacrimation increased	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0022 events1 affected11 at risk EG003
Swelling of eyelid	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Vision blurred	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0009 events2 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected10 at risk EG0016 events3 affected9 at risk EG0021 events1 affected11 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00041 events6 affected10 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Lip pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00031 events5 affected10 at risk EG00112 events4 affected9 at risk EG0025 events4 affected11 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Oral dysaesthesia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00034 events7 affected10 at risk EG00117 events5 affected9 at risk EG0028 events4 affected11 at risk EG003
Catheter site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Early satiety	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Face oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Facial pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected9 at risk EG0022 events1 affected11 at risk EG003
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00015 events6 affected10 at risk EG0013 events2 affected9 at risk EG0024 events4 affected11 at risk EG003
Gait disturbance	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Localised oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk EG003
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0014 events2 affected9 at risk EG0023 events3 affected11 at risk EG003
Candida infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Folliculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Hordeolum	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Lymph gland infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Skin infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected10 at risk EG0010 events0 affected9 at risk EG0022 events2 affected11 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0022 events2 affected11 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Radiation skin injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Recall phenomenon	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0022 events1 affected11 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Suture related complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Activated partial thromboplastin time	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0009 events2 affected10 at risk EG0019 events2 affected9 at risk EG0021 events1 affected11 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected10 at risk EG0016 events4 affected9 at risk EG0021 events1 affected11 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0013 events2 affected9 at risk EG0021 events1 affected11 at risk EG003
Blood bicarbonate decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Blood creatinine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Blood phosphorus increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Electrocardiogram pr shortened	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Electrocardiogram qt prolonged	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk EG003
Eosinophil percentage decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0017 events4 affected9 at risk EG0020 events0 affected11 at risk EG003
Haemoglobin increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Heart rate irregular	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
International normalised ratio increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected10 at risk EG00129 events5 affected9 at risk EG0026 events2 affected11 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00016 events3 affected10 at risk EG00113 events3 affected9 at risk EG00222 events5 affected11 at risk EG003
Neutrophil count increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Ph urine increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Platelet count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG00143 events7 affected9 at risk EG00212 events3 affected11 at risk EG003
Protein total decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Weight decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Weight increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
White blood cell count decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG00015 events2 affected10 at risk EG00145 events7 affected9 at risk EG00221 events3 affected11 at risk EG003
White blood cell count increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected9 at risk EG0020 events0 affected11 at risk EG003
White blood cells urine positive	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0008 events4 affected10 at risk EG0012 events1 affected9 at risk EG0022 events2 affected11 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Hyperalbuminaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0009 events3 affected10 at risk EG00110 events2 affected9 at risk EG0020 events0 affected11 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0022 events2 affected11 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0013 events2 affected9 at risk EG0021 events1 affected11 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events1 affected10 at risk EG0015 events3 affected9 at risk EG0021 events1 affected11 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG00012 events3 affected10 at risk EG0015 events4 affected9 at risk EG0020 events0 affected11 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events2 affected10 at risk EG0018 events2 affected9 at risk EG0020 events0 affected11 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0022 events1 affected11 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0015 events4 affected9 at risk EG0021 events1 affected11 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected10 at risk EG0012 events2 affected9 at risk EG0022 events2 affected11 at risk EG003
Hypouricaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Refeeding syndrome	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected10 at risk EG0012 events2 affected9 at risk EG0021 events1 affected11 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected10 at risk EG0010 events0 affected9 at risk EG0022 events2 affected11 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0013 events3 affected9 at risk EG0020 events0 affected11 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Dysarthria	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0013 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0008 events4 affected10 at risk EG0015 events2 affected9 at risk EG0020 events0 affected11 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Lethargy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Peripheral motor neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Somnolence	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Writer's cramp	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Abnormal behaviour	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Irritability	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Mood swings	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Fanconi syndrome acquired	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Ketonuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected10 at risk EG0012 events1 affected9 at risk EG0021 events1 affected11 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Bradypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0012 events1 affected9 at risk EG0023 events2 affected11 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0021 events1 affected11 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected9 at risk EG0022 events2 affected11 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected9 at risk EG0025 events4 affected11 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected9 at risk EG0020 events0 affected11 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events2 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events4 affected10 at risk EG0010 events0 affected9 at risk EG0024 events1 affected11 at risk EG003
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0022 events2 affected11 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Embolism	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Flushing	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected11 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected9 at risk EG0022 events1 affected11 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected11 at risk EG003
Pallor	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Pelvic venous thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003
Phlebitis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected11 at risk EG003

ID	Term
D009362	Neoplasm Metastasis

ID	Term
C000589393	olaratumab
D004317	Doxorubicin
D014750	Vincristine
D000077146	Irinotecan
D007069	Ifosfamide

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D002166	Camptothecin
D003520	Cyclophosphamide
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring

BG004NA± NAIndividual value reported = 10.0. Mean and Standard Deviation were not calculated.

EG0048 events6 affected13 at risk