A Study of LY3039478 in Participants With Advanced or Met... | NCT02784795 | Trialant
NCT02784795
Sponsor
Eli Lilly and Company
Status
Terminated
Last Update Posted
Aug 21, 2025Actual
Enrollment
94Actual
Phase
Phase 1
Conditions
Solid Tumor
Breast Cancer
Colon Cancer
Cholangiocarcinoma
Soft Tissue Sarcoma
Interventions
LY3039478
Taladegib
Abemaciclib
Cisplatin
Gemcitabine
Carboplatin
LY3023414
Countries
United States
Denmark
France
Spain
Protocol Section
Identification Module
NCT ID
NCT02784795
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16209
Secondary IDs
ID
Type
Description
Link
I6F-MC-JJCD
Other Identifier
Eli Lilly and Company
2015-004421-14
EudraCT Number
Brief Title
A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors
Official Title
A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated due to business considerations
Expanded Access Info
No
Start Date
Nov 4, 2016Actual
Primary Completion Date
Aug 9, 2018Actual
Completion Date
Feb 13, 2020Actual
First Submitted Date
May 25, 2016
First Submission Date that Met QC Criteria
May 25, 2016
First Posted Date
May 27, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 20, 2025
Results First Submitted that Met QC Criteria
Aug 1, 2025
Results First Posted Date
Aug 21, 2025Actual
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
Aug 1, 2025
Last Update Posted Date
Aug 21, 2025Actual
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)
No
Is FDA Regulated Drug
Not provided
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 of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.
25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period for pharmacokinetic (PK) evaluation.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 200 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
Number of Participants With LY3039478 Dose-Limiting Toxicities (DLT) in Part A, B, C, D and E
DLT is defined as an adverse event (AE) during Cycle 1 (28 days for Part A, B and C and 21 days for Part D, E) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of >5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
Baseline to toxicity (up to end of Cycle 1 [1Cycle = 28 days for Part A, B and C and 21 days for Part D, E])
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 in Combination With Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin in Part A, B, C, D and E
AUC[0-∞] of LY3039478 in combination with taladegib, LY3023414, abemaciclib, cisplatin/gemcitabine, and gemcitabine/carboplatin in dose escalation parts of Part A, B, C, D and E was evaluated.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.
For dose escalation for all combinations: The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.
For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).
For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >2 lines of systemic treatment for advanced or metastatic TNBC.
Have adequate organ function.
Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Have discontinued all previous therapies for cancer.
Exclusion Criteria:
Have current acute leukemia.
Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder 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)
Massard C, Cassier PA, Azaro A, Anderson B, Yuen E, Yu D, Oakley G 3rd, Benhadji KA, Pant S. A phase 1b study of crenigacestat (LY3039478) in combination with gemcitabine and cisplatin or gemcitabine and carboplatin in patients with advanced or metastatic solid tumors. Cancer Chemother Pharmacol. 2022 Oct;90(4):335-344. doi: 10.1007/s00280-022-04461-z. Epub 2022 Aug 28.
The study consists of 5 separate, parallel dose escalations (dose esc) followed by dose-confirmation (dose conf) study parts (Part A - E). LY3039478 is given in combination with taladegib for Part A, LY3023414 for Part B, abemaciclib (abema) for Part C, cisplatin (cis) and gemcitabine (gem) for Part C, and gemcitabine and carboplatin (carb) for Part E. A participant completed the study if they completed at least 1 cycle (1 cycle = 28 days for Part A, B and C and 21 days for Part D, E) .
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A:25 Milligram(mg) LY3039478+200 mg Taladegib(Cohort 1)
25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period for pharmacokinetic (PK) evaluation.
Participants receiving benefit may continue until disease progression.
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
0
More Info Module
Limitations and Caveats
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
Mar 15, 2016
Jan 5, 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
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
As per the study protocol design description, the study was conducted as multicenter, nonrandomized, open-label, Phase 1b study consisting of 5 separate, parallel dose escalations in patients with advanced/metastatic cancer from a variety of solid tumors followed by a dose-confirmation phase in specified tumor types.
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 150 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
Drug: LY3039478
Drug: Abemaciclib
Part D:25 mg LY3039478+25 Milligram/Square Meter (mg/m2) Cisplatin+1000 mg/m2 Gemcitabine (Cohort 1)
Experimental
25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
PK: AUC[0-∞] of LY3023414 in Combination With LY3039478 on Day 22 (Part B)
AUC[0-∞] of LY3023414 in combination with LY3039478 (Part B) on day 22 was evaluated. LY3023414 PK data is summarized only for dose escalation patients in Part B with intensive PK sampling.
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day -3 (Part C)
AUC[0-∞] of abemaciclib and AUC[0-tlast] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 3 (Part C) was evaluated.
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day 22 (Part C)
AUC[0-∞] of abemaciclib and AUC[0-tlast] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 22 (Part C) was evaluated.
DoR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression (Up To 12 Months)
Progression Free Survival (PFS) Time in Part A, B, C, D and E
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was 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. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. PFS time was summarized using Kaplan-Meier estimates.
Baseline to Objective Disease Progression or Death (Up To 1.91 Months for Part A, 7.69 Months for Part B, 11.53 Months for Part C, 19.52 Months for Part D, 7.03 Months for Part E)
Detroit
Michigan
48201
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Rigshospitalet
Copenhagen
København Ø
2100
Denmark
Institut Bergonie
Bordeaux
33076
France
Centre Leon Berard
Lyon
69373
France
Gustave Roussy
Villejuif
94805
France
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
Fundacion Jimenez Diaz
Madrid
28040
Spain
Hospital Madrid Norte Sanchinarro
Madrid
28050
Spain
Derived
Azaro A, Massard C, Tap WD, Cassier PA, Merchan J, Italiano A, Anderson B, Yuen E, Yu D, Oakley G 3rd, Benhadji KA, Pant S. A phase 1b study of the Notch inhibitor crenigacestat (LY3039478) in combination with other anticancer target agents (taladegib, LY3023414, or abemaciclib) in patients with advanced or metastatic solid tumors. Invest New Drugs. 2021 Aug;39(4):1089-1098. doi: 10.1007/s10637-021-01094-6. Epub 2021 Mar 8.
FG001
Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 200 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
FG004
Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 4-Dose Conf)
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 150 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
FG008
Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)
25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
FG009
Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)
50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression
25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
FG0008 subjects
FG0015 subjects
FG0024 subjects
FG0035 subjects
FG00418 subjects
FG0053 subjects
FG00612 subjects
FG0078 subjects
FG0086 subjects
FG00910 subjects
FG0105 subjects
FG01110 subjects
Received at Least One Dose of Study Drug
FG0008 subjects
FG0015 subjects
FG0024 subjects
FG0035 subjects
FG00418 subjects
FG0053 subjects
FG00612 subjects
FG0078 subjects
FG0086 subjects
FG00910 subjects
FG0105 subjects
FG01110 subjects
Completed at Least 1 Treatment Cycle
FG0008 subjects
FG0015 subjects
FG0024 subjects
FG0035 subjects
FG00418 subjects
FG0053 subjects
FG00612 subjects
FG0078 subjects
FG0086 subjects
FG00910 subjects
FG0105 subjects
FG01110 subjects
COMPLETED
FG0004 subjects
FG0014 subjects
FG0021 subjects
FG0033 subjects
FG00412 subjects
FG0053 subjects
FG0068 subjects
FG0077 subjects
FG0086 subjects
FG00910 subjects
FG0104 subjects
FG0116 subjects
NOT COMPLETED
FG0004 subjects
FG0011 subjects
FG0023 subjects
FG0032 subjects
FG0046 subjects
FG0050 subjects
FG0064 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0114 subjects
Type
Comment
Reasons
Progressive Disease
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All randomized participants in Part A, B, C, D and E.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)
25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
BG001
Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.
Participants receiving benefit may continue until disease progression.
BG008
Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)
25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
BG009
Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)
50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression
25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0015
BG0024
BG0035
BG00418
BG0053
BG00612
BG0078
BG0086
BG00910
BG0105
BG01110
BG01294
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00056.5± 16.8
BG00153.0± 8.5
BG00262.3± 3.9
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
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
United States
Title
Measurements
BG0003
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With LY3039478 Dose-Limiting Toxicities (DLT) in Part A, B, C, D and E
DLT is defined as an adverse event (AE) during Cycle 1 (28 days for Part A, B and C and 21 days for Part D, E) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of >5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
All participants who receive at least one dose of study drug in Part A, B, C, D and E.
Posted
Count of Participants
Participants
No
Baseline to toxicity (up to end of Cycle 1 [1Cycle = 28 days for Part A, B and C and 21 days for Part D, E])
ID
Title
Description
OG000
Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)
25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
OG001
Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3039478 in Combination With Taladegib, LY3023414, Abemaciclib, Cisplatin/Gemcitabine, and Gemcitabine/Carboplatin in Part A, B, C, D and E
AUC[0-∞] of LY3039478 in combination with taladegib, LY3023414, abemaciclib, cisplatin/gemcitabine, and gemcitabine/carboplatin in dose escalation parts of Part A, B, C, D and E was evaluated.
All participants who received at least one dose of study drug with intensive PK sampling in the dose escalation cohorts of Part A, B, C, D and E. PK data was interpreted by combining Part B (25 mg LY3039478 + 150/200 mg LY3023414; Cohorts 1 and 3) and Part C (25 mg LY3039478 + 100/150 mg abemaciclib; Cohorts 1 and 3) reporting arms as all participants received same dose of 50 mg LY3039478 (Part B and C Cohorts 1 and 2) and to increase the sample size for interpretability.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour/mL (ng*h/mL)
Parts A/B/C Day 22 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6, 8, 24-30 hours post-dose; Parts D/E Day 1 (Cycle 1) and 15 (Cycle 1): pre-dose, 0.5, 1, 2, 4, 6-8, 24-30 hours post-dose
ID
Title
Description
OG000
Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)
25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period.
Participants receiving benefit may continue until disease progression.
OG001
Part B:25 mg LY3039478+150mg/200 mg LY3023414(Cohort 1 and 3)
Secondary
PK: AUC[0-∞] of Taladegib and Its Active Metabolite LSN3185556, in Combination With LY3039478 (Part A)
AUC[0-∞] of taladegib and its active metabolite LSN3185556, in combination with LY3039478 (Part A) was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part A.
25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle. A single dose of 200 mg taladegib was also be given on day 1 during a 3-day lead-in period.
Participants receiving benefit may continue until disease progression.
Units
Counts
Participants
OG000
Secondary
PK: AUC[0-∞] of LY3023414 in Combination With LY3039478 on Day -3 (Part B)
AUC[0-∞] of LY3023414 in combination with LY3039478 (Part B) on day -3 was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part B. Day -3 Cohort 1 and 2 results for Parts B were combined as 'Part B:150 mg LY3023414 (Cohort 1 and Cohort 2)' since they are from same dose and were collected in the absence of LY3039478 co-administration. Part B Cohort 4 participants had sparse PK sampling limited to day 22 so day -3 PK results are not available/reported.
A single dose of 150 mg LY3023414 was given on day 1 during a 3-day lead-in period.
OG001
Part B: 200 mg LY3023414 (Cohort 3)
A single dose of 200 mg LY3023414 was given on day 1 during a 3-day lead-in period.
Participants receiving benefit may continue until disease progression.
Units
Counts
Participants
Secondary
PK: AUC[0-∞] of LY3023414 in Combination With LY3039478 on Day 22 (Part B)
AUC[0-∞] of LY3023414 in combination with LY3039478 (Part B) on day 22 was evaluated. LY3023414 PK data is summarized only for dose escalation patients in Part B with intensive PK sampling.
All participants who received at least one dose of study drug with intensive PK sampling in the dose escalation cohort of Part B
25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
Secondary
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day -3 (Part C)
AUC[0-∞] of abemaciclib and AUC[0-tlast] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 3 (Part C) was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part C. Day -3 Cohort 1 and 2 results for Parts B were combined as Part C: 100 mg Abemaciclib (Cohort 1 and Cohort 2) since they are from same dose and were collected in the absence of LY3039478 co-administration.
A single dose of 100 mg abemaciclib was given on day 1 during a 3-day lead-in period.
OG001
Part C:150 mg Abemaciclib (Cohort 3)
A single dose of 150 mg abemaciclib was given on day 1 during a 3-day lead-in period.
Participants receiving benefit may continue until disease progression.
Secondary
PK: AUC[0-∞] of Abemaciclib and AUC From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Its Major Active Metabolites LSN2839567 and LSN3106726, in Combination With LY3039478 on Day 22 (Part C)
AUC[0-∞] of abemaciclib and AUC[0-tlast] of its major active metabolites LSN2839567 and LSN3106726, in combination with LY3039478 on Day 22 (Part C) was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part C.
25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
Secondary
Duration of Response (DoR)
DoR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
Duration of Response was not calculated for any participant as the study was terminated prior to data collection.
Posted
Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression (Up To 12 Months)
ID
Title
Description
OG000
Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)
25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
OG001
Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
Secondary
Progression Free Survival (PFS) Time in Part A, B, C, D and E
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was 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. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. PFS time was summarized using Kaplan-Meier estimates.
All randomized participants in Part A, B, C, D and E. Censored participants: Part A= 2, Part B = 0, 4, 2 and 7, Part C = 0, 6 and 5, Part D = 2, 3, Part E = 3, 7.
Posted
Median
95% Confidence Interval
Months
Baseline to Objective Disease Progression or Death (Up To 1.91 Months for Part A, 7.69 Months for Part B, 11.53 Months for Part C, 19.52 Months for Part D, 7.03 Months for Part E)
ID
Title
Description
OG000
Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)
25 mg LY3039478 given orally TIW in combination with 200 mg taladegib given orally QD on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
Time Frame
Up To 2 Months for Part A, 8 Months for Part B, 12 Months for Part C, 39 Months for Part D and 10 Months for Part E
Description
All randomized participants who received at least one dose of study drug in Part A, B, C, D and E. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A:25 mg LY3039478+200 mg Taladegib(Cohort 1)
25 mg LY3039478 given orally 3 times per week (TIW) in combination with 200 mg taladegib given orally once daily (QD) on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
3
8
5
8
7
8
EG001
Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally twice daily (BID) on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.
Participants receiving benefit may continue until disease progression.
1
8
2
8
8
8
EG008
Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)
25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
0
6
2
6
6
6
EG009
Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)
50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
0
10
7
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0102 events2 affected5 at risk
EG0110 events0 affected10 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Face oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Campylobacter colitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Device related infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0016 events3 affected5 at risk
EG0021 events1 affected4 at risk
EG0033 events2 affected5 at risk
EG0045 events4 affected18 at risk
EG0058 events3 affected3 at risk
EG0061 events1 affected12 at risk
EG0077 events5 affected8 at risk
EG00821 events5 affected6 at risk
EG00912 events6 affected10 at risk
EG01023 events4 affected5 at risk
EG01125 events6 affected10 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Ear disorder
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Blepharitis
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Eye discharge
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Eyelash discolouration
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Keratitis
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Photophobia
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Xerophthalmia
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Colonic fistula
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0005 events2 affected8 at risk
EG0017 events4 affected5 at risk
EG0025 events3 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG00010 events5 affected8 at risk
EG0016 events4 affected5 at risk
EG0024 events2 affected4 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0005 events3 affected8 at risk
EG00111 events4 affected5 at risk
EG0023 events2 affected4 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0004 events3 affected8 at risk
EG0013 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Axillary pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected5 at risk
EG0023 events2 affected4 at risk
EG003
Feeling abnormal
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
General physical health deterioration
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Mucosal dryness
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0022 events1 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected5 at risk
EG0023 events1 affected4 at risk
EG003
Xerosis
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Bartholin's abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected1 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Device related infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Paronychia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected1 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0024 events1 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Blood culture positive
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Blood urea increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0012 events1 affected5 at risk
EG0023 events1 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Nutritional condition abnormal
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Transaminases increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Weight increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Appetite disorder
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0004 events3 affected8 at risk
EG0011 events1 affected5 at risk
EG0022 events2 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0003 events2 affected8 at risk
EG0015 events2 affected5 at risk
EG0026 events1 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG00110 events3 affected5 at risk
EG0025 events2 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Aphonia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Psychomotor skills impaired
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Seizure
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dermatillomania
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Dyspareunia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Vulval disorder
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected1 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected1 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Embolism
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Haematoma
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected4 at risk
EG003
This study was terminated without triggering the dose expansion cohorts for Parts D and E due to business considerations.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that the sponsor can review and comment on results communications prior to public release and can embargo communications regarding trial results for a period that is more than 30 days but less than or equal to 90 days from the time the sponsor receives the publication for review. The sponsor can request that the PI hold publishing the communication in order to protect any intellectual property interest at stake.
25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.
Participants receiving benefit may continue until disease progression.
OG008
Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)
25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
OG009
Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)
50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression
25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
5
OG00418
OG0053
OG00612
OG0078
OG0086
OG00910
OG0105
OG01110
3
OG0043
OG0050
OG0062
OG0070
OG0081
OG0093
OG0102
OG0110
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period in cohort 1 and 25 mg LY3039478 given orally TIW in combination with 200 mg LY3023414 given orally BID on a 28 day cycle in cohort 3.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle. A single dose of 150 mg LY3023414 was also be given on day 1 during a 3-day lead-in period.
Participants receiving benefit may continue until disease progression.
OG003
Part C:25 mg LY3039478+100 mg/150 mg Abema(Cohort 1 and 3)
25 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period in cohort 1 and 25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle in cohort 3.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 100 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 100 mg abemaciclib was also be given on day 1 during a 3-day lead-in period.
Participants receiving benefit may continue until disease progression.
OG005
Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)
25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
OG006
Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)
50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression
25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
Units
Counts
Participants
OG0001
OG0016
OG0021
OG0034
OG0044
OG0054
OG0067
OG0072
OG0087
Title
Denominators
Categories
Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0054
ParticipantsOG0067
ParticipantsOG0071
ParticipantsOG0087
Title
Measurements
OG0051210± 41
OG0063080± 35
OG007NA± NAAUC\[0-∞\] could not be calculated for one participant in the "Part E:25 mg LY3039478 + 1000 mg/m2 Gem + Carb (Cohort 1)" Arm for the Day 1
OG008
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 22
ParticipantsOG0001
ParticipantsOG0016
ParticipantsOG0021
ParticipantsOG0034
6
Title
Denominators
Categories
Taladegib: Day -3
ParticipantsOG0006
Title
Measurements
OG00017100± 48
Taladegib: Day 22
ParticipantsOG0001
Title
Measurements
OG000NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 15400 ng\*h/mL.
LSN3185556 (Metabolite): Day -3
ParticipantsOG0003
Title
Measurements
OG00031900± 49
LSN3185556 (Metabolite): Day 22
ParticipantsOG0001
Title
Measurements
OG000NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 26400 ng\*h/mL.
OG0008
OG0015
Title
Denominators
Categories
Title
Measurements
OG0002620± 52
OG0012780± 69
Units
Counts
Participants
OG0004
OG0011
OG0022
Title
Denominators
Categories
Title
Measurements
OG0002120± 50
OG001NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 2480 ng\*h/mL.
OG002NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual range value = 2900 - 12000 ng\*h/mL.
25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle. A single dose of 150 mg abemaciclib was also be given on day 1 during a 3-day lead-in period for PK evaluation.
Participants receiving benefit may continue until disease progression.
Units
Counts
Participants
OG0003
OG0012
OG0021
Title
Denominators
Categories
Abemaciclib
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0021
Title
Measurements
OG0005270± 88
OG001NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual range value = 2510 - 6370 ng\*h/mL.
OG002NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 3420 ng\*h/mL.
25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.
Participants receiving benefit may continue until disease progression.
OG008
Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)
25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
OG009
Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)
50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression
25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG001
Part B:25 mg LY3039478+150 mg LY3023414 (Cohort 1-Dose Esc)
25 mg LY3039478 given orally TIW in combination with 150 mg LY3023414 given orally BID on a 28 day cycle.
Participants receiving benefit may continue until disease progression.
25 mg LY3039478 given orally TIW in combination with 150 mg abemaciclib given orally BID on a 28-day cycle.
Participants receiving benefit may continue until disease progression.
OG008
Part D:25 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem (Cohort 1)
25 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and 1000 mg/m2 gemcitabine given as intravenous (IV) infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
OG009
Part D:50 mg LY3039478+25 mg/m2 Cis+1000 mg/m2 Gem(Cohort 2)
50 mg LY3039478 given orally TIW in combination with 25 mg/m2 cisplatin and1000 mg/m2 gemcitabine given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression
25 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and area under the plasma concentration-time curve dose of (AUC) carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
50 mg LY3039478 given orally TIW in combination with 1000 mg/m2 gemcitabine and AUC dose of carboplatin given as IV infusions on days 1 and 8 of a 21 day cycle.
Participants receiving benefit may continue until disease progression.
Units
Counts
Participants
OG0008
OG0015
OG0024
OG0035
OG00418
OG0053
OG00612
OG0078
OG0086
OG00910
OG0105
OG01110
Title
Denominators
Categories
Title
Measurements
OG0001.22(0.59 to 1.91)
OG0011.91(1.35 to 2.00)
OG002NA(NA to NA)There were no events in Part B of Cohort 2.
OG0031.91(1.87 to 7.69)
OG0041.84(0.92 to 3.68)
OG0051.94(1.61 to 11.53)
OG0061.91(1.38 to 5.72)
OG007NA(1.74 to NA)The upper limit of the 95% confidence Interval (CI) was not calculated due to the high censoring rate.
OG0083.22(2.96 to NA)The upper limit of the 95% confidence Interval (CI) was not calculated due to the high censoring rate.
OG0093.02(1.15 to 3.48)
OG0106.00(4.96 to 7.03)
OG0114.71(3.06 to 6.21)
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0092 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected10 at risk
EG0101 events1 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0042 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0064 events4 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0113 events2 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0093 events3 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected12 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0042 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
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EG0081 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0092 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0082 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0073 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0072 events1 affected8 at risk
EG0082 events2 affected6 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0112 events2 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
2 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected1 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected1 at risk
EG0110 events0 affected2 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected5 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected8 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
2 events
2 affected
5 at risk
EG0044 events4 affected18 at risk
EG0055 events2 affected3 at risk
EG0065 events4 affected12 at risk
EG0076 events1 affected8 at risk
EG0083 events2 affected6 at risk
EG0094 events4 affected10 at risk
EG0100 events0 affected5 at risk
EG0115 events2 affected10 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected12 at risk
EG0073 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0093 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0043 events3 affected18 at risk
EG0055 events2 affected3 at risk
EG0060 events0 affected12 at risk
EG0072 events1 affected8 at risk
EG0081 events1 affected6 at risk
EG0092 events2 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0044 events4 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected6 at risk
EG0093 events2 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
3 events
2 affected
5 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected3 at risk
EG0063 events2 affected12 at risk
EG0073 events1 affected8 at risk
EG0083 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0101 events1 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0103 events1 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0054 events2 affected3 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected8 at risk
EG0084 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0083 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0072 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0111 events1 affected10 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected18 at risk
EG0055 events1 affected3 at risk
EG0063 events3 affected12 at risk
EG0073 events1 affected8 at risk
EG0082 events1 affected6 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
1 events
1 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0063 events1 affected12 at risk
EG0072 events2 affected8 at risk
EG0082 events1 affected6 at risk
EG0096 events3 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0054 events3 affected3 at risk
EG0060 events0 affected12 at risk
EG0072 events2 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0082 events1 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0072 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0064 events2 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0072 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
7 events
2 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0074 events4 affected8 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0055 events2 affected3 at risk
EG0065 events4 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0093 events2 affected10 at risk
EG0102 events2 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0101 events1 affected5 at risk
EG0110 events0 affected10 at risk
8 events
3 affected
5 at risk
EG0043 events2 affected18 at risk
EG0053 events1 affected3 at risk
EG0061 events1 affected12 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected6 at risk
EG0092 events2 affected10 at risk
EG0104 events1 affected5 at risk
EG0111 events1 affected10 at risk
0 events
0 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
0 events
0 affected
5 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
1 events
1 affected
5 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
1 events
1 affected
5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected10 at risk
EG0100 events0 affected5 at risk
EG0110 events0 affected10 at risk
3400
± 70
Participants
OG004
0
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0072
ParticipantsOG0082
Title
Measurements
OG0051030± 9
OG006NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 1980 ng\*h/mL.
OG007NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual range = 804 -1400 ng\*h/mL.
OG008NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual range = 3350 - 3620 ng\*h/mL.
Participants
OG004
4
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
Title
Measurements
OG000NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 295 ng\*h/mL.
OG0012660± 31
OG002NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 4250 ng\*h/mL.
OG0031820± 44
OG0045080± 12
663
± 82
1510
± 76
1460
± 82
OG001NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 2130 ng\*h/mL.
OG002NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 914 ng\*h/mL.
NA
± NA
Data reported as individual values when participants analyzed (n) were less than 3. Individual range value = 2150 - 2690 ng\*h/mL.
OG001NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 4120 ng\*h/mL.
OG002NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value = 2590 ng\*h/mL.