A Study of Olaratumab (LY3012207) in Participants With Ad... | NCT02659020 | Trialant
NCT02659020
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
May 9, 2022Actual
Enrollment
310Actual
Phase
Phase 1Phase 2
Conditions
Soft Tissue Sarcoma
Interventions
Olaratumab
Gemcitabine
Docetaxel
Placebo
Countries
United States
Australia
France
Germany
Hungary
Israel
Italy
Poland
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02659020
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15839
Secondary IDs
ID
Type
Description
Link
I5B-MC-JGDL
Other Identifier
Eli Lilly and Company
2015-001316-34
EudraCT Number
Brief Title
A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
Official Title
A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma
Acronym
ANNOUNCE 2
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Apr 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 1, 2016Actual
Primary Completion Date
Jul 28, 2020Actual
Completion Date
Apr 27, 2021Actual
First Submitted Date
Jan 15, 2016
First Submission Date that Met QC Criteria
Jan 15, 2016
First Posted Date
Jan 20, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 26, 2021
Results First Submitted that Met QC Criteria
Sep 14, 2021
Results First Posted Date
Oct 11, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 15, 2022
Last Update Posted Date
May 9, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
Drug: Olaratumab
Drug: Gemcitabine
Drug: Docetaxel
Phase 2: Olaratumab + Gemcitabine + Docetaxel
Experimental
Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE Version 4.0:
Febrile neutropenia with documented Grade ≥3 infection or sepsis
Grade 4 neutropenia lasting 7 days or longer.
Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage.
Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, or diarrhoea that can be controlled with optimal medical management within 48 hours.
Cycle 1 (Up To 21 Days)
Phase 2: Overall Survival (OS) (Olaratumab-Naive)
OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
Baseline to Date of Death Due to Any Cause (Up To 38 Months)
Secondary Outcomes
Measure
Description
Time Frame
Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab
Cmax of Olaratumab.
Pre-dose, 5 minutes (min), 1, 4, 4.5, 24, 96, 168, 336 hours (h) post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8
Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The participant may have no more than 2 prior lines of systemic therapies (neoadjuvant and adjuvant therapies will not be considered as a prior line of therapy) for advanced or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy. All previous therapies must have completed ≥ 3 weeks (21 days) prior to first dose of study drug.
In the Phase 2 part, prior olaratumab/doxorubicin combination therapy in 1 prior treatment line is allowed.
Prior olaratumab therapy must have been received with doxorubicin as indicated on the olaratumab label.
Prior olaratumab therapy must have included at least 2 full cycles of olaratumab/doxorubicin (that is, a minimum of 4 doses of olaratumab).
Participants, who completed at least 2 cycles of combination olaratumab/doxorubicin therapy then discontinued doxorubicin due to toxicity or maximum dosing and proceeded to olaratumab monotherapy, are eligible.
The most recent dose of olaratumab must have been received within 180 days of randomization in this study.
Availability of tumor tissue is mandatory for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future central pathology review and translational research (if archived tissue is unavailable).
The participant has adequate hematologic, organ, and coagulation function within 2 weeks (14 days) prior to enrollment (Phase 1b) or randomization (Phase 2).
Exclusion Criteria:
The participant is diagnosed with gastrointestinal stromal tumor (GIST) or Kaposi sarcoma.
The participant has active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment (Phase 1b) or randomization (Phase 2). Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment (Phase 1b) /randomization (Phase 2) to rule out brain metastasis.
The participant has received prior treatment with gemcitabine or docetaxel. Note: Participants previously enrolled in the I5B-MC-JGDJ (NCT02451943) or any other blinded study with olaratumab are not eligible to participate in this trial.
The participant has electively planned or will require major surgery during the course of the study.
Females who are pregnant or breastfeeding.
The participant has an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
16 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
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
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UCLA Medical Center
Santa Monica
California
90404
United States
University of Colorado Cancer Center
References Module
Citations
Not provided
See Also Links
Label
URL
A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma (ANNOUNCE-2)
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 19, 2017
Jun 8, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Olaratumab
Drug: Gemcitabine
Drug: Docetaxel
Phase 2: Placebo + Gemcitabine + Docetaxel
Placebo Comparator
Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
Baseline to Date of Death Due to Any Cause (Up To 38 Months)
Phase 2: Progression Free Survival (PFS)
PFS was defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available.
Baseline to Objective Disease Progression or Death from Any Cause (Up To 38 Months)
Phase 2: Percentage of Participants With a Complete or Partial Response (Objective Response Rate [ORR])
ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Baseline to Objective Disease Progression or Start of New Anti-Cancer Therapy (Up To 38 Months)
Phase 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD)
DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up To 38 Months)
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the patient has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
Baseline to Follow-up (Up To 24 Months)
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
Baseline to Follow-up (Up to 33 months)
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
Cycle 1 (Day 1), Follow-up (Up to 38 Months)
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Number of Participants with Treatment Emergent Anti-Olaratumab Antibodies
Baseline through Follow-Up (Up to 38 Months)
Aurora
Colorado
80045
United States
Mayo Clinic-Jacksonville
Jacksonville
Florida
32224
United States
Sylvester Comprehensive Cancer Center
Miami
Florida
33136
United States
Georgia Cancer Specialists PC
Atlanta
Georgia
30342
United States
Johns Hopkins University School of Medicine
Baltimore
Maryland
21287
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Washington University Medical School
St Louis
Missouri
63110
United States
Nebraska Methodist Cancer Center
Omaha
Nebraska
68114
United States
Monter Cancer Center
Lake Success
New York
11042
United States
Columbia University Medical Center
New York
New York
10032
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Ohio State University Medical Center
Columbus
Ohio
43210
United States
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa
Oklahoma
74146
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111-2497
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232-6307
United States
University of Texas Southwestern Medical Center at Dallas
Dallas
Texas
75390
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Utah Cancer Specialists
Salt Lake City
Utah
84106
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Royal Adelaide Hospital
Adelaide
South Australia
5000
Australia
Peter MacCallum Cancer Centre
Melbourne
Victoria
3000
Australia
Institut Bergonie
Bordeaux
33076
France
Centre Oscar Lambret
Lille
59020
France
Gustave Roussy
Villejuif
94805
France
Universitätsklinikum Ulm
Ulm
Baden-Wurttemberg
89081
Germany
Klinikum der Universität München
München
Bavaria
81377
Germany
Universitätsklinikum Regensburg
Regensburg
Bavaria
93053
Germany
Helios Klinikum Bad Saarow
Bad Saarow
Brandenburg
15526
Germany
Medizinische Hochschule Hannover
Hanover
Lower Saxony
30625
Germany
HELIOS Klinikum Berlin-Buch
Berlin
13125
Germany
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
Szolnok
5000
Hungary
Sheba Medical Center
Tel Litwinsky
Ramat Gan
5265601
Israel
Rambam Medical Center
Haifa
3525408
Israel
Rabin Medical Center
Petah Tikva
4941492
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv
6423906
Israel
Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro
Candiolo
Torino
10060
Italy
Humanitas Gradenigo
Torino
10153
Italy
Centrum Onkologii-Instytut im Marii Sklodowskiej-Curie
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG00118
BG00215
BG00381
BG00446
BG00586
BG00643
BG007310
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
<65 years
Title
Measurements
BG00020
BG00112
BG0026
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Hungary
Title
Measurements
BG0000
BG0010
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
Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT)
A Dose Limiting Toxicity is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE Version 4.0:
Febrile neutropenia with documented Grade ≥3 infection or sepsis
Grade 4 neutropenia lasting 7 days or longer.
Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage.
Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, or diarrhoea that can be controlled with optimal medical management within 48 hours.
Phase 1b: All participants who received at least one dose of Olaratumab.
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Units
Counts
Participants
OG00021
OG00118
OG00215
Title
Denominators
Categories
Title
Measurements
OG0001
OG0014
OG0023
Primary
Phase 2: Overall Survival (OS) (Olaratumab-Naive)
OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
Phase 2: All randomized participants (including the censored participants). Number of participants censored in "Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) =30," "Placebo + Gemcitabine + Docetaxel (Olaratumab-naive) =28."
Posted
Median
95% Confidence Interval
Months
Baseline to Date of Death Due to Any Cause (Up To 38 Months)
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Secondary
Phase 1b: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Olaratumab
Cmax of Olaratumab.
Phase 1b: All participants who received at least one dose of Olaratumab and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter (μg/mL)
Pre-dose, 5 minutes (min), 1, 4, 4.5, 24, 96, 168, 336 hours (h) post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
Secondary
Phase 1b: PK: Minimum Serum Concentration (Cmin) of Olaratumab
Cmin of Olaratumab.
Phase 1b: All participants who received at least one dose of Olaratumab and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
Secondary
Phase 1b: PK: Elimination Half-Life (T1/2) of Olaratumab
T1/2 of Olaratumab.
Phase 1b: All participants who received at least one dose of Olaratumab and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
days
Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 3 Day 1, Cycle 3 Day 8
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
Secondary
Phase 1b/2: PK: Cmax of Gemcitabine
Cmax of Gemcitabine.
Phase 1b/2: All participants who received at least one dose of Gemcitabine and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion)
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
OG002
Phase 2: Olaratumab + Gemcitabine + Docetaxel
Secondary
Phase 1b/2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of Gemcitabine
AUC[0-∞] of Gemcitabine
Phase 1b/2: Zero participants analysed. Due to short half-life of Gemcitabine, there was insufficient quantifiable data in the elimination phase to calculate AUC[0-∞] for any of the participants.
Posted
Day 8 of Cycle 1 (end of infusion, 1, 2, 4, 24 hours post-infusion)
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
Secondary
Phase 1b/2: PK: Cmax of Docetaxel
Cmax of Docetaxel.
Phase 1b/2: All participants who received at least one dose of Docetaxel and had evaluable PK data.
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
OG002
Phase 2: Olaratumab + Gemcitabine + Docetaxel
Secondary
Phase 1b/2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Docetaxel
AUC [0-∞] of Docetaxel.
Phase 1b/2: All participants who received at least one dose of Docetaxel and had evaluable PK data. For phase 2, zero participants analysed due to data not collected for AUC [0-∞] of Docetaxel.
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met (cohort 2). Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2 (cohort 2 expansion).
Secondary
Phase 1b/2: Population PK: Clearance of Olaratumab
Population PK: Clearance of Olaratumab
Phase 1b/2: All participants who received at least one dose of Olaratumab and had evaluable PK data. Phase 1b and phase 2 participants olaratumab PK data was planned to be pooled for the population PK analysis and compared to a validated PK model to confirm that PK parameters were similar to analyses from previous olaratumab studies.
Posted
Mean
95% Confidence Interval
Liter Per Hour
Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8
ID
Title
Description
OG000
Olaratumab + Gemcitabine + Docetaxel
Participants received intravenous infusions of olaratumab on days 1, 8 (phase 1: 15 or 20 mg/kg; phase 2: 20 mg/kg only in cycle 1 and 15 mg/kg in subsequent cycles) plus gemcitabine 900 mg/m^2 on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Units
Counts
Participants
OG000
Secondary
Phase 1b/2: Population PK: Volume of Distribution at Steady State (Vss) of Olaratumab
The Vss is the sum of central volume of distribution (V1) + peripheral volume of distribution (V2).
Phase 1b/2: All participants who received at least one dose of Olaratumab and had evaluable PK data. Phase 1b and phase 2 participants olaratumab PK data was planned to be pooled for the population PK analysis and compared to a validated PK model to confirm that PK parameters were similar to analyses from previous olaratumab studies.
Posted
Mean
95% Confidence Interval
Liter
Cycle 1-19: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on days 1, 8
ID
Title
Description
OG000
Olaratumab + Gemcitabine + Docetaxel
Participants received intravenous infusions of olaratumab on days 1, 8 (phase 1: 15 or 20 mg/kg; phase 2: 20 mg/kg only in cycle 1 and 15 mg/kg in subsequent cycles) plus gemcitabine 900 mg/m^2 on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
Phase 2: All randomized participants (including the censored participants). Number of participants censored in "Olaratumab + Gemcitabine + Docetaxel (Olaratumab Pre-Treated) = 20," "Placebo + Gemcitabine + Docetaxel (Olaratumab Pre-Treated) =15."
Posted
Median
95% Confidence Interval
Months
Baseline to Date of Death Due to Any Cause (Up To 38 Months)
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Secondary
Phase 2: Progression Free Survival (PFS)
PFS was defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available.
Phase 2: All randomized participants (including the censored participants). Number of participants censored in "Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive)=20" "Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)=21," "Olaratumab + Gemcitabine + Docetaxel (Olaratumab pre-treated)=12," "Placebo + Gemcitabine + Docetaxel (Olaratumab pre-treated)=16."
Posted
Median
95% Confidence Interval
Months
Baseline to Objective Disease Progression or Death from Any Cause (Up To 38 Months)
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Secondary
Phase 2: Percentage of Participants With a Complete or Partial Response (Objective Response Rate [ORR])
ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Phase 2: All randomized participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline to Objective Disease Progression or Start of New Anti-Cancer Therapy (Up To 38 Months)
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Secondary
Phase 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD)
DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Phase 2: All randomized participants.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up To 38 Months)
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Secondary
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the patient has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
Phase 2: All randomized participants who had baseline and at least one post-baseline assessment (including the censored participants). Number of participants censored in "Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) = 30," "Placebo + Gemcitabine + Docetaxel (Olaratumab-naive)=23," "Olaratumab + Gemcitabine + Docetaxel (Olaratumab pre-treated)=17," "Placebo + Gemcitabine + Docetaxel (Olaratumab pre-treated)=8."
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Secondary
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
Phase 2: All randomized participants who had baseline and at least one post-baseline assessment.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Secondary
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
Phase 2: All randomized participants who completed EQ-5D-5L.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Time Frame
Baseline to Follow-up (Up To 38 Months)
Description
Phase 1b/2: All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Participants received intravenous infusions of olaratumab 20 mg/kg on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Following a protocol amendment, additional participants were enrolled into this group to confirm the safety of the 20 mg/kg dose level prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 milligrams per kilogram (mg/kg) on days 1, 8 plus gemcitabine 900 milligrams per meter square (mg/m^2) on days 1, 8 plus docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
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Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG0037 events4 affected81 at risk
EG0042 events2 affected45 at risk
EG0055 events4 affected86 at risk
EG0060 events0 affected43 at risk
Bandaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Haemolytic uraemic syndrome
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hypochromic anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Normocytic anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Influenza like illness
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Peripheral swelling
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Sudden death
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0004 events1 affected21 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Cystitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Device related infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Influenza
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0003 events2 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Sepsis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Septic shock
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Skin infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Viral infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Arterial bypass occlusion
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0005 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Platelet count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Troponin increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Headache
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Seizure
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Syncope
Nervous system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Embolism
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Haematoma
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Peripheral artery stenosis
Vascular disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG00042 events13 affected21 at risk
EG00154 events12 affected18 at risk
EG00224 events9 affected15 at risk
EG003168 events43 affected81 at risk
EG004145 events33 affected45 at risk
EG005147 events47 affected86 at risk
EG00657 events20 affected43 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0004 events3 affected21 at risk
EG0014 events3 affected18 at risk
EG0025 events2 affected15 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 21.0
Systematic Assessment
EG0008 events2 affected21 at risk
EG0013 events3 affected18 at risk
EG00212 events4 affected15 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Dry eye
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0002 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Photopsia
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Vision blurred
Eye disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0004 events2 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0008 events6 affected21 at risk
EG0017 events3 affected18 at risk
EG0026 events4 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG00022 events7 affected21 at risk
EG00114 events8 affected18 at risk
EG0028 events5 affected15 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0013 events3 affected18 at risk
EG0022 events1 affected15 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0010 events0 affected18 at risk
EG0022 events1 affected15 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Intestinal fistula
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0008 events5 affected21 at risk
EG00115 events9 affected18 at risk
EG0024 events3 affected15 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0013 events2 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0008 events4 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21.0
Systematic Assessment
EG0005 events3 affected21 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Asthenia
General disorders
MedDRA 21.0
Systematic Assessment
EG00021 events4 affected21 at risk
EG0018 events2 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Catheter site pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Chills
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0013 events2 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Device related thrombosis
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Face oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Fatigue
General disorders
MedDRA 21.0
Systematic Assessment
EG00032 events13 affected21 at risk
EG00135 events14 affected18 at risk
EG00221 events12 affected15 at risk
EG003
Influenza like illness
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Localised oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Malaise
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Non-pitting oedema
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21.0
Systematic Assessment
EG00013 events8 affected21 at risk
EG0019 events5 affected18 at risk
EG0028 events5 affected15 at risk
EG003
Pain
General disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Peripheral swelling
General disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 21.0
Systematic Assessment
EG0008 events6 affected21 at risk
EG00111 events8 affected18 at risk
EG0022 events2 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected15 at risk
EG003
Cystitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Paronychia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Skin infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0012 events2 affected18 at risk
EG0023 events3 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected11 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG0010 events0 affected18 at risk
EG0022 events2 affected15 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0007 events5 affected21 at risk
EG00113 events6 affected18 at risk
EG0022 events2 affected15 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG0017 events4 affected18 at risk
EG0022 events2 affected15 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG0016 events3 affected18 at risk
EG0022 events2 affected15 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0014 events3 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0005 events4 affected21 at risk
EG0015 events3 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0013 events3 affected18 at risk
EG0022 events2 affected15 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0003 events1 affected21 at risk
EG00115 events4 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0003 events1 affected21 at risk
EG0017 events5 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Platelet count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG00115 events7 affected18 at risk
EG0022 events2 affected15 at risk
EG003
Transaminases increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0023 events1 affected15 at risk
EG003
Weight decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0016 events4 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Weight increased
Investigations
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG00111 events4 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0006 events5 affected21 at risk
EG0018 events6 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG0015 events4 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0012 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0014 events3 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0014 events4 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG00110 events5 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0008 events1 affected21 at risk
EG0014 events3 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0003 events2 affected21 at risk
EG0014 events3 affected18 at risk
EG0023 events2 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0006 events4 affected21 at risk
EG0017 events5 affected18 at risk
EG0027 events6 affected15 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG0013 events3 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0015 events2 affected18 at risk
EG0020 events0 affected15 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0011 events1 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0009 events7 affected21 at risk
EG0016 events6 affected18 at risk
EG0024 events4 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0014 events2 affected18 at risk
EG0021 events1 affected15 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs1).
Hazard Ratio (HR)
0.945
2-Sided
95
0.639
1.397
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
Units
Counts
Participants
OG00020
OG00133
Title
Denominators
Categories
Cycle 1 (Day 1)
ParticipantsOG00019
ParticipantsOG00133
Title
Measurements
OG000432± 24
OG001572± 25
Cycle 1 (Day 8)
ParticipantsOG00020
ParticipantsOG00133
Title
Measurements
OG000460± 25
OG001
Cycle 3 (Day 1)
ParticipantsOG00014
ParticipantsOG00123
Title
Measurements
OG000523± 38
OG001
Cycle 3 (Day 8)
ParticipantsOG00014
ParticipantsOG00122
Title
Measurements
OG000513± 21
OG001
Units
Counts
Participants
OG00020
OG00131
Title
Denominators
Categories
Cycle 1 (Day 1)
ParticipantsOG00020
ParticipantsOG00131
Title
Measurements
OG00095.9± 37
OG001142± 38
Cycle 1 (Day 8)
ParticipantsOG00019
ParticipantsOG00130
Title
Measurements
OG00064.3± 64
OG001
Cycle 3 (Day 1)
ParticipantsOG00014
ParticipantsOG00122
Title
Measurements
OG000137± 40
OG001
Units
Counts
Participants
OG00019
OG00133
Title
Denominators
Categories
Cycle 1 (Day 1)
ParticipantsOG00019
ParticipantsOG00133
Title
Measurements
OG0004.60± 34
OG0014.29± 28
Cycle 1 (Day 8)
ParticipantsOG00019
ParticipantsOG00133
Title
Measurements
OG0006.25± 25
OG001
Cycle 3 (Day 1)
ParticipantsOG00014
ParticipantsOG00123
Title
Measurements
OG0005.17± 36
OG001
Cycle 3 (Day 8)
ParticipantsOG00014
ParticipantsOG00121
Title
Measurements
OG0005.82± 30
OG001
Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
OG003
Phase 2: Placebo + Gemcitabine + Docetaxel
Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Units
Counts
Participants
OG00018
OG00124
OG00287
OG00388
Title
Denominators
Categories
Title
Measurements
OG0002.79± 70
OG0013.49± 50
OG0023.01± 122
OG0032.35± 105
OG002
Phase 2: Olaratumab + Gemcitabine + Docetaxel
Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
OG003
Phase 2: Placebo + Gemcitabine + Docetaxel
Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
OG003
Phase 2: Placebo + Gemcitabine + Docetaxel
Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Units
Counts
Participants
OG00018
OG00130
OG00271
OG00373
Title
Denominators
Categories
Title
Measurements
OG000903± 143
OG0011110± 84
OG0021030± 134
OG003827± 102
OG002
Phase 2: Olaratumab + Gemcitabine + Docetaxel
Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
OG003
Phase 2: Placebo + Gemcitabine + Docetaxel
Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met. This cohort is a combination of participants who never received olaratumab (olaratumab-naive) and who received commercially available olaratumab (olaratumab pre-treated) prior to enrollment.
Units
Counts
Participants
OG0007
OG00118
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0004440± 103
OG0012990± 83
178
Title
Denominators
Categories
Title
Measurements
OG0000.0186(0.0175 to 0.0192)
178
Title
Denominators
Categories
Title
Measurements
OG0005.14(4.68 to 5.54)
Units
Counts
Participants
OG00046
OG00143
Title
Denominators
Categories
Title
Measurements
OG00019.84(14.19 to NA)There were not enough events to estimate the upper confidence limit.
OG00117.31(10.81 to 20.30)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.148
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.667
2-Sided
95
0.385
1.158
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Units
Counts
Participants
OG00081
OG00186
OG00246
OG00343
Title
Denominators
Categories
Title
Measurements
OG0007.62(5.13 to 8.54)
OG0014.37(2.86 to 6.87)
OG0025.45(2.76 to 8.71)
OG0034.17(2.20 to 6.90)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.055
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.692
2-Sided
95
0.476
1.007
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Log Rank
0.482
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Units
Counts
Participants
OG00081
OG00186
OG00246
OG00343
Title
Denominators
Categories
Title
Measurements
OG00032.1(22.2 to 43.4)
OG00123.3(14.8 to 33.6)
OG00230.4(17.7 to 45.8)
OG00314(5.3 to 27.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Exact Mantel-Haenszel test
0.1891
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Odds Ratio (OR)
1.589
2-Sided
95
0.794
3.179
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Exact Mantel-Haenszel test
0.0642
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Odds Ratio (OR)
2.668
2-Sided
95
0.923
7.710
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Units
Counts
Participants
OG00081
OG00186
OG00246
OG00343
Title
Denominators
Categories
Title
Measurements
OG00074.1(63.1 to 83.2)
OG00172.1(61.4 to 81.2)
OG00267.4(52.0 to 80.5)
OG00362.8(46.7 to 77.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Exact Mantel-Haenszel test
0.7724
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Odds Ratio (OR)
1.106
2-Sided
95
0.558
2.194
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Exact Mantel-Haenszel test
0.6508
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Odds Ratio (OR)
1.222
2-Sided
95
0.513
2.911
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Units
Counts
Participants
OG00068
OG00171
OG00241
OG00334
Title
Denominators
Categories
Title
Measurements
OG0003.61(2.66 to 8.57)
OG0012.27(1.41 to 6.54)
OG0023.15(1.41 to 7.62)
OG0032.20(0.76 to 3.02)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.073
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.661
2-Sided
95
0.419
1.041
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Log Rank
0.225
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.703
2-Sided
95
0.395
1.253
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Units
Counts
Participants
OG00075
OG00180
OG00245
OG00341
Title
Denominators
Categories
Fatigue
ParticipantsOG00075
ParticipantsOG00177
ParticipantsOG00244
ParticipantsOG00339
Title
Measurements
OG0000.95(0.76 to 1.12)
OG0010.95(0.76 to 1.45)
OG0020.85(0.72 to 1.41)
OG003
Nausea and vomiting
ParticipantsOG00074
ParticipantsOG00178
ParticipantsOG00244
ParticipantsOG00341
Pain
ParticipantsOG00073
ParticipantsOG00177
ParticipantsOG00244
ParticipantsOG00335
Dyspnoea
ParticipantsOG00074
ParticipantsOG00178
ParticipantsOG00243
ParticipantsOG00339
Insomnia
ParticipantsOG00068
ParticipantsOG00174
ParticipantsOG00241
ParticipantsOG00338
Appetite loss
ParticipantsOG00073
ParticipantsOG00176
ParticipantsOG00245
ParticipantsOG00337
Constipation
ParticipantsOG00073
ParticipantsOG00177
ParticipantsOG00244
ParticipantsOG00340
Diarrhoea
ParticipantsOG00075
ParticipantsOG00180
ParticipantsOG00244
ParticipantsOG00341
Financial difficulties
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00243
ParticipantsOG00335
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fatigue
Log Rank
0.332
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.213
2-Sided
95
0.834
1.764
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG000
OG001
Nausea and vomiting
Log Rank
0.389
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.813
2-Sided
95
0.514
1.287
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG000
OG001
Pain
Log Rank
0.020
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.598
2-Sided
95
0.386
0.926
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG000
OG001
Dyspnoea
Log Rank
0.821
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.947
2-Sided
95
0.622
1.442
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG000
OG001
Insomnia
Log Rank
0.812
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.931
2-Sided
95
0.574
1.509
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG000
OG001
Appetite loss
Log Rank
0.162
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.355
2-Sided
95
0.893
2.055
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG000
OG001
Constipation
Log Rank
0.619
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.881
2-Sided
95
0.550
1.413
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG000
OG001
Diarrhoea
Log Rank
0.597
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.134
2-Sided
95
0.746
1.724
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG000
OG001
Financial difficulties
Log Rank
0.380
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.766
2-Sided
95
0.425
1.381
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Fatigue
Log Rank
0.877
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.046
2-Sided
95
0.635
1.723
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Nausea and vomiting
Log Rank
0.791
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.102
2-Sided
95
0.568
2.139
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Pain
Log Rank
0.487
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
0.810
2-Sided
95
0.454
1.443
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Dyspnoea
Log Rank
0.976
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.014
2-Sided
95
0.556
1.850
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Insomnia
Log Rank
0.111
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.694
2-Sided
95
0.882
3.250
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Appetite loss
Log Rank
0.760
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.108
2-Sided
95
0.620
1.979
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Constipation
Log Rank
0.747
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.119
2-Sided
95
0.586
2.135
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Diarrhoea
Log Rank
0.330
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.367
2-Sided
95
0.726
2.576
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
OG002
OG003
Financial difficulties
Log Rank
0.411
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Hazard Ratio (HR)
1.373
2-Sided
95
0.636
2.965
Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).
Superiority
This cohort included participants who never received olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of olaratumab loading dose 20 mg/kg on days 1, 8 of cycle 1 followed by 15 mg/kg on days 1, 8 of all subsequent cycles in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
This cohort included participants who received commercially available olaratumab prior to enrollment. Participants received intravenous infusions of placebo on days 1, 8 in combination with gemcitabine 900 mg/m^2 on days 1, 8 and docetaxel 75 mg/m^2 on day 8 of a 21-day cycle until disease progression, unacceptable toxicity, death, or other discontinuation criteria were met.
Units
Counts
Participants
OG00071
OG00175
OG00242
OG00335
Title
Denominators
Categories
EQ-5D-5L - Index Value [Cycle 1 (Day 1)]
ParticipantsOG00071
ParticipantsOG00174
ParticipantsOG00239
ParticipantsOG00335
Title
Measurements
OG0000.80± 0.17
OG0010.81± 0.17
OG0020.83± 0.15
OG003
EQ-5D-5L - VAS Score [Cycle 1 (Day 1)]
ParticipantsOG00071
ParticipantsOG00175
ParticipantsOG00242
ParticipantsOG00335
EQ-5D-5L - Index Value [Follow-up (Up to 38 Months)]
ParticipantsOG00042
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG003
EQ-5D-5L - VAS Score [Follow-up (Up to 38 Months)]
ParticipantsOG00042
ParticipantsOG00150
ParticipantsOG00226
ParticipantsOG003
Units
Counts
Participants
OG00077
OG00143
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
6 events
6 affected
81 at risk
EG0041 events1 affected45 at risk
EG0053 events3 affected86 at risk
EG0061 events1 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0052 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0061 events1 affected43 at risk
1 events
1 affected
81 at risk
EG0042 events2 affected45 at risk
EG0052 events2 affected86 at risk
EG0061 events1 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0061 events1 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0052 events2 affected86 at risk
EG0060 events0 affected43 at risk
3 events
2 affected
81 at risk
EG0045 events3 affected45 at risk
EG0055 events3 affected86 at risk
EG0062 events2 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0061 events1 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0061 events1 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0061 events1 affected43 at risk
2 events
2 affected
81 at risk
EG0041 events1 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
3 events
2 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0061 events1 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0043 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
2 events
2 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
3 events
3 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0061 events1 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0061 events1 affected43 at risk
2 events
2 affected
81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0061 events1 affected43 at risk
10 events
7 affected
81 at risk
EG0042 events2 affected45 at risk
EG0058 events7 affected86 at risk
EG0066 events6 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0061 events1 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0061 events1 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
2 events
2 affected
81 at risk
EG0041 events1 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
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5 affected
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6 affected
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1 affected
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10 affected
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9 affected
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1 affected
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6 affected
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1 affected
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16 affected
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13 affected
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1 affected
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11 affected
81 at risk
EG0044 events3 affected45 at risk
EG00512 events9 affected86 at risk
EG0064 events4 affected43 at risk
20 events
12 affected
81 at risk
EG00421 events13 affected45 at risk
EG00511 events11 affected86 at risk
EG00618 events14 affected43 at risk
23 events
15 affected
81 at risk
EG0047 events6 affected45 at risk
EG00515 events13 affected86 at risk
EG0065 events5 affected43 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
10 events
7 affected
81 at risk
EG0040 events0 affected45 at risk
EG0055 events5 affected86 at risk
EG0061 events1 affected43 at risk
4 events
3 affected
81 at risk
EG0045 events4 affected45 at risk
EG0054 events4 affected86 at risk
EG0063 events3 affected43 at risk
6 events
3 affected
81 at risk
EG0042 events1 affected45 at risk
EG0058 events3 affected86 at risk
EG0060 events0 affected43 at risk
15 events
10 affected
81 at risk
EG00420 events10 affected45 at risk
EG00531 events13 affected86 at risk
EG00614 events9 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
4 events
3 affected
81 at risk
EG0042 events2 affected45 at risk
EG0056 events2 affected86 at risk
EG0063 events3 affected43 at risk
5 events
4 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0063 events3 affected43 at risk
5 events
5 affected
81 at risk
EG0042 events2 affected45 at risk
EG0055 events5 affected86 at risk
EG0064 events3 affected43 at risk
2 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0052 events2 affected86 at risk
EG0062 events2 affected43 at risk
17 events
15 affected
81 at risk
EG0047 events6 affected45 at risk
EG0058 events7 affected86 at risk
EG00611 events10 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
6 events
5 affected
81 at risk
EG0040 events0 affected45 at risk
EG0053 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
3 events
3 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0062 events1 affected43 at risk
22 events
16 affected
81 at risk
EG00421 events13 affected45 at risk
EG00527 events21 affected86 at risk
EG00610 events9 affected43 at risk
30 events
19 affected
81 at risk
EG00430 events15 affected45 at risk
EG00525 events18 affected86 at risk
EG00619 events12 affected43 at risk
0 events
0 affected
81 at risk
EG0044 events2 affected45 at risk
EG0057 events5 affected86 at risk
EG0061 events1 affected43 at risk
19 events
16 affected
81 at risk
EG0046 events5 affected45 at risk
EG00522 events17 affected86 at risk
EG00611 events9 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0052 events1 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0061 events1 affected43 at risk
3 events
3 affected
81 at risk
EG0042 events2 affected45 at risk
EG0050 events0 affected86 at risk
EG0063 events1 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
2 events
2 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0062 events2 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
11 events
9 affected
81 at risk
EG0044 events4 affected45 at risk
EG0056 events6 affected86 at risk
EG0060 events0 affected43 at risk
4 events
2 affected
81 at risk
EG0047 events6 affected45 at risk
EG0051 events1 affected86 at risk
EG0064 events4 affected43 at risk
8 events
7 affected
81 at risk
EG0043 events3 affected45 at risk
EG0051 events1 affected86 at risk
EG0063 events3 affected43 at risk
3 events
3 affected
81 at risk
EG0046 events4 affected45 at risk
EG0056 events5 affected86 at risk
EG0064 events3 affected43 at risk
0 events
0 affected
81 at risk
EG0041 events1 affected45 at risk
EG0051 events1 affected86 at risk
EG0061 events1 affected43 at risk
3 events
2 affected
81 at risk
EG0043 events3 affected45 at risk
EG0052 events2 affected86 at risk
EG0061 events1 affected43 at risk
35 events
29 affected
81 at risk
EG0045 events5 affected45 at risk
EG00544 events32 affected86 at risk
EG0065 events5 affected43 at risk
4 events
3 affected
81 at risk
EG0045 events4 affected45 at risk
EG0053 events2 affected86 at risk
EG0065 events2 affected43 at risk
4 events
3 affected
81 at risk
EG0045 events5 affected45 at risk
EG0056 events5 affected86 at risk
EG0065 events5 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0052 events1 affected86 at risk
EG0060 events0 affected43 at risk
5 events
5 affected
81 at risk
EG0040 events0 affected45 at risk
EG0056 events5 affected86 at risk
EG0061 events1 affected43 at risk
5 events
5 affected
81 at risk
EG0043 events3 affected45 at risk
EG0054 events4 affected86 at risk
EG0063 events2 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0055 events2 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0048 events7 affected45 at risk
EG0053 events3 affected86 at risk
EG0064 events2 affected43 at risk
16 events
6 affected
81 at risk
EG0048 events3 affected45 at risk
EG0057 events4 affected86 at risk
EG0065 events2 affected43 at risk
8 events
8 affected
81 at risk
EG0043 events2 affected45 at risk
EG0058 events6 affected86 at risk
EG0063 events3 affected43 at risk
17 events
15 affected
81 at risk
EG0041 events1 affected45 at risk
EG00517 events11 affected86 at risk
EG0063 events2 affected43 at risk
17 events
10 affected
81 at risk
EG0047 events6 affected45 at risk
EG0057 events6 affected86 at risk
EG0063 events3 affected43 at risk
1 events
1 affected
81 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
6 events
3 affected
81 at risk
EG0043 events3 affected45 at risk
EG0054 events4 affected86 at risk
EG0060 events0 affected43 at risk
0 events
0 affected
33 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected28 at risk
EG0060 events0 affected15 at risk
1 events
1 affected
81 at risk
EG0042 events2 affected45 at risk
EG0056 events6 affected86 at risk
EG0062 events2 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
13 events
10 affected
81 at risk
EG0042 events2 affected45 at risk
EG0057 events4 affected86 at risk
EG0066 events5 affected43 at risk
5 events
4 affected
81 at risk
EG0041 events1 affected45 at risk
EG0059 events5 affected86 at risk
EG0063 events3 affected43 at risk
20 events
5 affected
81 at risk
EG0046 events6 affected45 at risk
EG00523 events7 affected86 at risk
EG0067 events6 affected43 at risk
4 events
4 affected
81 at risk
EG0048 events8 affected45 at risk
EG0055 events5 affected86 at risk
EG0062 events2 affected43 at risk
0 events
0 affected
81 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected43 at risk
1 events
1 affected
81 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected43 at risk
697
± 20
644
± 20
689
± 20
93.3
± 47
252
± 36
6.62
± 27
6.36
± 41
6.39
± 32
0.76
(0.72 to 1.84)
Title
Measurements
OG0003.78(2.14 to NA)There were not enough events to estimate the upper confidence limit.
OG0012.46(0.99 to 13.34)
OG0023.98(1.41 to NA)There were not enough events to estimate the upper confidence limit.
OG00313.17(1.64 to NA)There were not enough events to estimate the upper confidence limit.
Title
Measurements
OG0004.67(2.33 to 9.53)
OG0010.99(0.79 to 2.76)
OG0022.43(1.41 to 8.77)
OG0033.06(0.76 to 5.55)
Title
Measurements
OG0002.14(1.51 to 3.06)
OG0012.14(1.48 to 2.86)
OG0022.33(1.45 to 14.09)
OG0032.79(1.45 to 8.05)
Title
Measurements
OG0005.32(2.33 to 7.72)
OG0014.24(1.48 to 16.82)
OG0021.91(1.41 to 6.47)
OG0035.09(1.45 to NA)There were not enough events to estimate the upper confidence limit.
Title
Measurements
OG0001.12(0.82 to 2.14)
OG0012.56(1.64 to 3.98)
OG0021.41(0.85 to 3.52)
OG0031.97(1.38 to 4.04)
Title
Measurements
OG0003.25(2.14 to 5.98)
OG0012.86(1.48 to NA)There were not enough events to estimate the upper confidence limit.
OG0024.63(1.91 to 12.91)
OG0033.81(1.97 to NA)There were not enough events to estimate the upper confidence limit.
Title
Measurements
OG0001.41(0.99 to 3.68)
OG0011.81(1.41 to 4.24)
OG0023.55(1.41 to 6.05)
OG0033.52(1.97 to NA)There were not enough events to estimate the upper confidence limit.
Title
Measurements
OG000NA(5.32 to NA)There were not enough events to estimate the median, upper confidence limit.
OG0017.66(3.29 to NA)There were not enough events to estimate the upper confidence limit.
OG0027.29(2.33 to 7.85)
OG003NA(3.94 to NA)There were not enough events to estimate the upper confidence limit.