A Study of Abemaciclib (LY2835219) in Combination With An... | NCT02079636 | Trialant
NCT02079636
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 11, 2020Actual
Enrollment
142Actual
Phase
Phase 1
Conditions
Carcinoma, Non-small Cell Lung
Interventions
Abemaciclib
Pemetrexed
Gemcitabine
Ramucirumab
LY3023414
Pembrolizumab
Countries
United States
Spain
Protocol Section
Identification Module
NCT ID
NCT02079636
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15266
Secondary IDs
ID
Type
Description
Link
I3Y-MC-JPBJ
Other Identifier
Eli Lilly and Company
2013-004648-41
EudraCT Number
KEYNOTE-238
Other Identifier
Merck
Brief Title
A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)
Official Title
A Phase 1b Study of LY2835219 in Combination With Multiple Single Agent Options for Patients With Stage IV NSCLC
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Nov 15, 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03763604Approved for marketing
Start Date
Mar 28, 2014Actual
Primary Completion Date
May 2, 2018Actual
Completion Date
Aug 29, 2019Actual
First Submitted Date
Mar 4, 2014
First Submission Date that Met QC Criteria
Mar 4, 2014
First Posted Date
Mar 6, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 22, 2020
Results First Submitted that Met QC Criteria
Aug 22, 2020
Results First Posted Date
Sep 11, 2020Actual
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 22, 2020
Last Update Posted Date
Sep 11, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Merck Sharp & Dohme LLC
INDUSTRY
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 and tolerability of abemaciclib in combination with another anti-cancer drug in participants with NSCLC that is advanced or has spread to other parts of the body (stage IV). The study will also investigate how the body processes the combination treatment and how the study drug affects the body. The study will also collect disease-related symptoms and participant-reported pain related to NSCLC.
Detailed Description
Not provided
Conditions Module
Conditions
Carcinoma, Non-small Cell Lung
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
142Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Abemaciclib + Pemetrexed
Experimental
150 milligram (mg) or 200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Drug: Pemetrexed
Abemaciclib + Gemcitabine
Experimental
150 mg or 200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 milligram/square meter (mg/m^2) gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Drug: Gemcitabine
Abemaciclib + Ramucirumab
Experimental
150 mg or 200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Drug: Ramucirumab
Abemaciclib + LY3023414
Experimental
100 mg or 150 mg or 200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100, 150, or 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Abemaciclib
Drug
Administered orally
Abemaciclib + Gemcitabine
Abemaciclib + LY3023414
Abemaciclib + Pembrolizumab
Abemaciclib + Pemetrexed
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicities (DLT) or DLT-equivalent in Part A, B, C, D and E
A DLT defined as adverse event(AE) occurring between Day 1 and Day 21 of Cycle 1 that was considered at least possibly related to either abemaciclib or the combination therapy and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 [NCI-CTCAE v 4.0] [NCI 2009]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr) and for Part D participants (pts): Gr3 hyperglycemia (fasting) of <5 days, Gr3 hypertriglyceridemia or hyperlipidemia without optimal treatment.A DLT-equivalent defined as AE that would have met the criteria for DLT if it had occurred during Cycle 1 for pts enrolled in dose-escalation phase,but that occurs between 1)Day 1 and Day 21 of Cycle 2 and beyond for a participant enrolled in dose-escalation phase 2) at any time for a participant in dose-expansion phase.
Baseline through study completion (Up To 15 Months)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) in Part A, B, C, D and E
ORR is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For all Parts: The participant must have stage IV non-small cell lung cancer (NSCLC).
For Part A (abemaciclib + pemetrexed): Non-squamous subtypes only. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC.
For Part B (abemaciclib + gemcitabine): Any subtype. The participant must have received at least one but not more than three prior therapies for advanced/metastatic NSCLC.
For Part C (abemaciclib + ramucirumab): Any subtype. The participant must have received at least two but not more than three prior therapies for advanced/metastatic NSCLC.
For Part D (abemaciclib + LY3023414): Any subtype. The participant must have received at least two, but not more than three prior therapies for advanced/metastatic NSCLC. The participant must not have received prior treatment with any phosphoinositide 3-kinase (PI3K) or mammalian target of rapamycin (mTOR) inhibitor.
For Part E (abemaciclib + pembrolizumab): Any subtype. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC.
Have either measureable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Have adequate organ function including:
Hematologic: Absolute neutrophil count (ANC) 1.5 x 109/liter (L), platelets 100 x 109/L, and hemoglobin 8 gram/deciliter (g/dL).
Hepatic: Bilirubin 1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate transaminase (AST) 3.0 times ULN. For participants with tumor involvement of the liver, AST and ALT equaling ≤5.0 times ULN are acceptable. Alkaline phosphatase ≤5.0 times ULN for participants with tumor involvement of the bone is acceptable.
Renal: Serum creatinine 1.5 times ULN.
Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia.
Male and female participants of reproductive potential must agree to use medically approved contraceptive precautions during the trial and 3 to 4 months (as appropriate) following last dose of study drug.
Have an estimated life expectancy of ≥12 weeks.
Are able to swallow oral medications.
Exclusion Criteria:
Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Participants with controlled atrial fibrillation for >30 days prior to study treatment are eligible.
Parts A, B, D and E: Have central nervous system (CNS) metastasis with development of associated neurological changes 14 days prior to receiving study drug.
Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 3 to 4 months after the last dose of trial treatment (as appropriate).
Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies). Screening is not required for enrollment.
Parts A, B, C, and E: Have QTc interval of > 470 millisecond (msec) on screening electrocardiogram (ECG). Part D participants have QTc interval of >450msec on screening ECG.
Additional Exclusion Criteria For Part C
History or evidence of cardiovascular risk including any of the following:
History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment.
History or evidence of current ≥Class II congestive heart failure as defined by New York Heart Association.
Treatment refractory hypertension defined as a blood pressure of systolic >140 millimeter of mercury (mmHg) and/or diastolic >90 mmHg which cannot be controlled by antihypertensive therapy.
Participants with intracardiac defibrillators.
History or evidence of CNS disease. Radiographic screening of all participants without history of CNS metastasis is required.
Radiographically documented evidence of major vessel invasion or encasement by cancer.
Uncontrolled thromboembolic or hemorrhagic disorders.
Participants receiving daily treatment with aspirin >325mg/day or other known inhibitors of platelet function.
History of gross hemoptysis within 2 months of study entry.
Evidence of nonhealing wounds, ulcers, or bone fractures within 28 days prior to study entry.
Undergone major surgery within 28 days prior to first dose of study drug or have subcutaneous venous access device placement within 7 days prior to first dose.
Additional Exclusion Criteria For Part D
Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.
Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained by oral anti-diabetic agents as documented by hemoglobin A1c (HbA1c) <7%.
History or evidence of cardiovascular risk including any of the following -- History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment.
Additional Exclusion Criteria for Part E
Received prior monoclonal antibody (mAb) within 4 weeks prior to study.
Has active autoimmune disease that has required treatment in the past 2 years.
Has history of interstitial lung disease or pneumonitis.
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)
Kim ES, Kelly K, Paz-Ares LG, Garrido P, Jalal S, Mahadevan D, Gutierrez M, Provencio M, Schaefer E, Shaheen M, Johnston EL, Turner PK, Kambhampati SRP, Beckmann R, Hossain A, John WJ, Goldman JW. Abemaciclib in Combination with Single-Agent Options in Patients with Stage IV Non-Small Cell Lung Cancer: A Phase Ib Study. Clin Cancer Res. 2018 Nov 15;24(22):5543-5551. doi: 10.1158/1078-0432.CCR-18-0651. Epub 2018 Aug 6.
Click here for more information about this study: A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
Completers include participants who had cycle 1 and had received greater than or equal to (>=) 75% of Abemaciclib drug in cycle 1.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: 150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours (Q12H) on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
SAP
No
Yes
No
Statistical Analysis Plan
Apr 22, 2016
Feb 25, 2020
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
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Abemaciclib
Drug: LY3023414
Abemaciclib + Pembrolizumab
Experimental
100 mg or 150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Drug: Abemaciclib
Drug: Pembrolizumab
Abemaciclib + Ramucirumab
LY2835219
Pemetrexed
Drug
Administered IV
Abemaciclib + Pemetrexed
Alimta
Gemcitabine
Drug
Administered IV
Abemaciclib + Gemcitabine
Gemzar
Ramucirumab
Drug
Administered IV
Abemaciclib + Ramucirumab
Cyramza
LY3023414
Drug
Administered orally
Abemaciclib + LY3023414
Pembrolizumab
Drug
Administered IV
Abemaciclib + Pembrolizumab
Keytruda
Baseline through study completion (Up To 15 Months)
Progression Free Survival Time in Part A, B, C, D and E
Progression free survival (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.
Date of first dose until first documented progression or death (Up To 15 Months)
Change From Baseline in MD Anderson Symptom Inventory Scale-Lung Cancer (MDASI-LC) in Part A, B, C, D and E
The MDASI-LC is a self-reported lung cancer instrument included 22 items covered by one of the following dimensions: Mean core symptom severity (Core items 1-13: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sad, vomiting, numbness/tingling), Lung cancer symptoms (3 items: coughing, constipation, sore throat), Mean symptom severity (13 core items plus 3 lung items) and Interference with mood or functional status (6 items: general activity, mood, work, relations with other people, walking, enjoyment of life). The mean of all symptom subscale items was calculated where 0 equals "not present" and 10 equals "as bad as you can imagine." A change from baseline with negative values indicate improvement, positive values indicate worsening.
Baseline, through study completion (Up To 15 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib on Day 1 and at Steady State (Cycle 2 Day 1) in Part A , B, C, D and E
Cmax of Abemaciclib on day 1 and at steady State (Cycle 2 Day 1) Part A , B, C, D and E was evaluated.
Cycle 1 Day 1 (C1D1) pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; Cycle 2 Day 1 (C2D1) pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
Pharmacokinetics: Maximum Concentration (Cmax) of Pemetrexed at Steady State in Part A
Cmax of pemetrexed at steady state in Part A was evaluated.
C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
PK: Dose-normalized Maximum Concentration (Cmax) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B
Cmax of active gemcitabine metabolite (dFdU) on day 1 and at steady state (Cycle 2 Day 1) dose-normalized to 1250 mg/m^2 in Part B was evaluated.
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
PK: Maximum Concentration (Cmax) of Ramucirumab at 1 Hour Post-End-of-Infusion in Part C
Cmax of ramucirumab at 1 hour post-end-of-Infusion in Part C was evaluated.
C1D1 and C2D1: 1 hour post-end-of-infusion
PK: Maximum Concentration (Cmax) of LY3023414 in Part D
Cmax of LY3023414 in Part D was evaluated.
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
PK: Area Under the Concentration Curve (AUC) of Abemaciclib in Part A, B, C, D and E
Area under the concentration time curve from zero to 8 hours AUC(0-8h) of abemaciclib in Part A, B, C, D and E was evaluated.
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
PK: Area Under the Concentration Curve (AUC) of Pemetrexed at Steady State in Part A
Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]) of Pemetrexed in Part A was evaluated.
C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
PK: Area Under the Concentration Curve (AUC) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B
Area under the plasma concentration time curve from time zero to 12 hours (AUC[0-12h]) of active gemcitabine metabolite (dFdU) in Part B was evaluated
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
PK: Area Under the Concentration Curve (AUC) of LY3023414 in Part D
Area under the plasma concentration versus time curve from time zero to infinity (AUC) of LY3023414 in Part D was evaluated. For Day 1, AUC is defined as AUC from time zero to infinity (AUC[0-∞]), for steady state, AUC is defined as AUC from time zero to the end of the dosing interval, tau (AUC[0-tau ])
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
Los Angeles
California
90095
United States
University of California, Davis - Health Systems
Sacramento
California
95817
United States
Indiana Cancer Pavilion
Indianapolis
Indiana
46202
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
University of New Mexico Cancer Center
Albuquerque
New Mexico
87102
United States
Carolinas Medical Center
Charlotte
North Carolina
28204
United States
The West Clinic
Germantown
Tennessee
38138
United States
Hospital Universitario Ramon y Cajal
Madrid
28034
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Majadahonda
28222
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seville
41013
Spain
Derived
Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13.
FG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG002
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG003
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG004
Part C: 150 mg Abemaciclib + 10mg/kg Ramucirumab Day 1
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG005
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG006
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG007
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG008
Part D: 100 mg Abemaciclib + 100 mg LY3023414
100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG009
Part D: 150 mg Abemaciclib + 100 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG010
Part D: 150 mg Abemaciclib + 150 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG011
Part D: 200 mg Abemaciclib + 150 mg LY3023414
200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG012
Part D: 150 mg Abemaciclib + 200 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG013
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab
100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG014
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
FG0008 subjects
FG00115 subjects
FG0023 subjects
FG00321 subjects
FG0044 subjects
FG00519 subjects
FG00612 subjects
FG0074 subjects
FG0083 subjects
FG0099 subjects
FG01010 subjects
FG0116 subjects
FG0128 subjects
FG0133 subjects
FG01417 subjects
Received at Least One Dose of Study Drug
FG0008 subjects
FG00115 subjects
FG0023 subjects
FG00321 subjects
FG0044 subjects
FG00519 subjects
FG00612 subjects
FG0074 subjects
FG0083 subjects
FG0099 subjects
FG01010 subjects
FG0116 subjects
FG0128 subjects
FG0133 subjects
FG01417 subjects
COMPLETED
FG0005 subjects
FG00113 subjects
FG0023 subjects
FG0039 subjects
FG0042 subjects
FG00513 subjects
FG00611 subjects
FG0073 subjects
FG0083 subjects
FG0096 subjects
FG0108 subjects
FG0114 subjects
FG0125 subjects
FG0133 subjects
FG01412 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG00312 subjects
FG0042 subjects
FG0056 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0093 subjects
FG0102 subjects
FG0112 subjects
FG0123 subjects
FG0130 subjects
FG0145 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0035 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0121 subjects
FG0130 subjects
FG0142 subjects
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Progressive disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All randomized participants who received at least one dose of study drug in Part A, B, C, D and E.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG002
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG003
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG004
Part C:150 mg Abemaciclib+10mg/kg Ramucirumab Day1
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG005
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG006
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG007
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG008
Part D: 100 mg Abemaciclib + 100 mg LY3023414
100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG009
Part D: 150 mg Abemaciclib + 100 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG010
Part D: 150 mg Abemaciclib + 150 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG011
Part D: 200 mg Abemaciclib + 150 mg LY3023414
200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG012
Part D: 150 mg Abemaciclib + 200 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG013
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab
100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG014
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG00115
BG0023
BG00321
BG0044
BG00519
BG00612
BG0074
BG0083
BG0099
BG01010
BG0116
BG0128
BG0133
BG01417
BG015142
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
BG00063.88± 7.61
BG00162.53± 11.19
BG00255.00± 8.66
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0015
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
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
BG0006
BG0018
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 Dose-Limiting Toxicities (DLT) or DLT-equivalent in Part A, B, C, D and E
A DLT defined as adverse event(AE) occurring between Day 1 and Day 21 of Cycle 1 that was considered at least possibly related to either abemaciclib or the combination therapy and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 [NCI-CTCAE v 4.0] [NCI 2009]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr) and for Part D participants (pts): Gr3 hyperglycemia (fasting) of <5 days, Gr3 hypertriglyceridemia or hyperlipidemia without optimal treatment.A DLT-equivalent defined as AE that would have met the criteria for DLT if it had occurred during Cycle 1 for pts enrolled in dose-escalation phase,but that occurs between 1)Day 1 and Day 21 of Cycle 2 and beyond for a participant enrolled in dose-escalation phase 2) at any time for a participant in dose-expansion phase.
All randomized participants who received at least one dose of study drug in Part A, B, C, D and E.
Posted
Count of Participants
Participants
No
Baseline through study completion (Up To 15 Months)
ID
Title
Description
OG000
Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG003
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG004
Part C:150 mg Abemaciclib+10 mg/kg Ramucirumab Day 1
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG0008
OG00115
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0014
OG0020
OG003
Secondary
Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) in Part A, B, C, D and E
ORR is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
All randomized participants who received at least one dose of study drug in Part A, B, C, D and E.
Posted
Count of Participants
Participants
No
Baseline through study completion (Up To 15 Months)
ID
Title
Description
OG000
Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Secondary
Progression Free Survival Time in Part A, B, C, D and E
Progression free survival (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= 13, Part B = 7, Part C = 17, Part D = 19, Part E = 10.
Posted
Median
95% Confidence Interval
Months
Date of first dose until first documented progression or death (Up To 15 Months)
ID
Title
Description
OG000
Part A:Abemaciclib + 500 mg/m^2 Pemetrexed
150/200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Secondary
Change From Baseline in MD Anderson Symptom Inventory Scale-Lung Cancer (MDASI-LC) in Part A, B, C, D and E
The MDASI-LC is a self-reported lung cancer instrument included 22 items covered by one of the following dimensions: Mean core symptom severity (Core items 1-13: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sad, vomiting, numbness/tingling), Lung cancer symptoms (3 items: coughing, constipation, sore throat), Mean symptom severity (13 core items plus 3 lung items) and Interference with mood or functional status (6 items: general activity, mood, work, relations with other people, walking, enjoyment of life). The mean of all symptom subscale items was calculated where 0 equals "not present" and 10 equals "as bad as you can imagine." A change from baseline with negative values indicate improvement, positive values indicate worsening.
All randomized participants for cycles which at least 25% of participants in each arm have a score. MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC result in Part A, B, C, D and E.
Posted
Mean
Inter-Quartile Range
units on a scale
Baseline, through study completion (Up To 15 Months)
ID
Title
Description
OG000
Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib on Day 1 and at Steady State (Cycle 2 Day 1) in Part A , B, C, D and E
Cmax of Abemaciclib on day 1 and at steady State (Cycle 2 Day 1) Part A , B, C, D and E was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part A , B, C, D and E.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Cycle 1 Day 1 (C1D1) pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; Cycle 2 Day 1 (C2D1) pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of Pemetrexed at Steady State in Part A
Cmax of pemetrexed at steady state in Part A was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter (μg/mL)
C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Secondary
PK: Dose-normalized Maximum Concentration (Cmax) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B
Cmax of active gemcitabine metabolite (dFdU) on day 1 and at steady state (Cycle 2 Day 1) dose-normalized to 1250 mg/m^2 in Part B was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part B.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Secondary
PK: Maximum Concentration (Cmax) of Ramucirumab at 1 Hour Post-End-of-Infusion in Part C
Cmax of ramucirumab at 1 hour post-end-of-Infusion in Part C was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part C.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter (μg/mL)
C1D1 and C2D1: 1 hour post-end-of-infusion
ID
Title
Description
OG000
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Day 1
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8
Secondary
PK: Maximum Concentration (Cmax) of LY3023414 in Part D
Cmax of LY3023414 in Part D was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
Part D: 100 or 150 mg Abemaciclib + 100 mg LY3023414
100 or 150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part D: 150 or 200 mg Abemaciclib + 150 mg LY3023414
150 or 200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part D: 150 mg Abemaciclib + 200 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Secondary
PK: Area Under the Concentration Curve (AUC) of Abemaciclib in Part A, B, C, D and E
Area under the concentration time curve from zero to 8 hours AUC(0-8h) of abemaciclib in Part A, B, C, D and E was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part A, B, C, D and E.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour/mL (ng*h/mL)
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
Part A:150 Milligram(mg) Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 milligrams/square meter (mg/m^2) pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
Secondary
PK: Area Under the Concentration Curve (AUC) of Pemetrexed at Steady State in Part A
Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]) of Pemetrexed in Part A was evaluated.
All randomized participants who received at least one dose of study drug with evaluable PK data in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram*hour per milliliter (μg*hr/mL)
C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
Part A:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met
OG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Secondary
PK: Area Under the Concentration Curve (AUC) of Active Gemcitabine Metabolite: 2',2'-Difluorodeoxyuridine (dFdU) on Day 1 and at Steady State (Cycle 2 Day 1) in Part B
Area under the plasma concentration time curve from time zero to 12 hours (AUC[0-12h]) of active gemcitabine metabolite (dFdU) in Part B was evaluated
All randomized participants who received at least one dose of study drug with evaluable PK data in Part B.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour/mL (ng*h/mL)
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Secondary
PK: Area Under the Concentration Curve (AUC) of LY3023414 in Part D
Area under the plasma concentration versus time curve from time zero to infinity (AUC) of LY3023414 in Part D was evaluated. For Day 1, AUC is defined as AUC from time zero to infinity (AUC[0-∞]), for steady state, AUC is defined as AUC from time zero to the end of the dosing interval, tau (AUC[0-tau ])
All randomized participants who received at least one dose of study drug with evaluable PK data in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram*hour/mL (ng*h/mL)
C1D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose; C2D1 pre-dose and 1, 2, 4, 6, 8, 10 h post-dose
ID
Title
Description
OG000
Part D: 100 or 150 mg Abemaciclib + 100 mg LY3023414
100 or 150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG001
Part D: 150 or 200 mg Abemaciclib + 150 mg LY3023414
150 or 200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg or 150 mg or 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Time Frame
Up to 4 years and 1 Month
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:150 mg Abemaciclib + 500 mg/m^2 Pemetrexed
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
2
8
4
8
8
8
EG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given IV over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
1
15
8
15
15
15
EG002
Part B:150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
1
3
1
3
3
3
EG003
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
6
21
10
21
21
21
EG004
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Day1
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
2
4
3
4
4
4
EG005
Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day1
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
4
19
12
19
19
19
EG006
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
1
12
3
12
12
12
EG007
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
1
4
3
4
4
4
EG008
Part D: 100 mg Abemaciclib + 100 mg LY3023414
100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
0
3
1
3
3
3
EG009
Part D: 150 mg Abemaciclib + 100 mg LY3023414
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
1
9
2
9
8
9
EG010
Part D: 150 mg Abemaciclib + 150 mg LY3023414
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
0
10
3
10
10
10
EG011
Part D: 200 mg Abemaciclib + 150 mg LY3023414
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
1
6
0
6
5
6
EG012
Part D: 150 mg Abemaciclib + 200 mg LY3023414
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
1
8
4
8
8
8
EG013
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab
100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
0
3
0
3
3
3
EG014
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
2
17
9
17
16
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0013 events3 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0013 events3 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Stress cardiomyopathy
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Death
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Device related infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Scrotal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Myocardial strain
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0021 events1 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Subclavian artery thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 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
EG00020 events6 affected8 at risk
EG00124 events12 affected15 at risk
EG0022 events1 affected3 at risk
EG00344 events10 affected21 at risk
EG0040 events0 affected4 at risk
EG00513 events5 affected19 at risk
EG0063 events2 affected12 at risk
EG0070 events0 affected4 at risk
EG0083 events2 affected3 at risk
EG0098 events3 affected9 at risk
EG0102 events2 affected10 at risk
EG0110 events0 affected6 at risk
EG0123 events3 affected8 at risk
EG0134 events2 affected3 at risk
EG01412 events6 affected17 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0014 events3 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0006 events1 affected8 at risk
EG00112 events4 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0015 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Ventricular dysfunction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Eye swelling
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected3 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG00119 events5 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal tenderness
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 events3 affected8 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0007 events4 affected8 at risk
EG00131 events14 affected15 at risk
EG0021 events1 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected15 at risk
EG0022 events1 affected3 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0006 events5 affected8 at risk
EG00113 events6 affected15 at risk
EG0023 events3 affected3 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Oral mucosal discolouration
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 events3 affected8 at risk
EG00118 events4 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Face oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG00014 events5 affected8 at risk
EG00132 events12 affected15 at risk
EG0024 events2 affected3 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
General physical health deterioration
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Generalised oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0014 events4 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected8 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected8 at risk
EG0013 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Temperature intolerance
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Furuncle
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0022 events2 affected3 at risk
EG003
Nasal vestibulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pyoderma
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Scrotal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Tongue fungal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Viral rash
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Procedural anxiety
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Spinal column injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG00013 events5 affected8 at risk
EG0015 events3 affected15 at risk
EG0022 events1 affected3 at risk
EG003
Electrocardiogram qt prolonged
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram t wave abnormal
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0014 events3 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Heart rate increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0009 events5 affected8 at risk
EG00117 events4 affected15 at risk
EG0029 events2 affected3 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0009 events3 affected8 at risk
EG0017 events4 affected15 at risk
EG0021 events1 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0014 events4 affected15 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0009 events3 affected8 at risk
EG0013 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected8 at risk
EG00117 events9 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0016 events2 affected15 at risk
EG0022 events1 affected3 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Fluid intake reduced
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0015 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0013 events3 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0013 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0005 events2 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0004 events1 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected3 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day 1
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG006
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG007
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG008
Part D: 100 mg Abemaciclib + 100 mg LY3023414
100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG009
Part D: 150 mg Abemaciclib + 100 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG010
Part D: 150 mg Abemaciclib + 150 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG011
Part D: 200 mg Abemaciclib + 150 mg LY3023414
200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG012
Part D: 150 mg Abemaciclib + 200 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG013
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab
100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG014
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
21
OG0044
OG00519
OG00612
OG0074
OG0083
OG0099
OG01010
OG0116
OG0128
OG0133
OG01417
5
OG0041
OG0054
OG0061
OG0073
OG0081
OG0091
OG0101
OG0111
OG0122
OG0130
OG0140
OG002
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG003
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG004
Part C:150 mg Abemaciclib+10mg/kg Ramucirumab Day1
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG005
Part C: 200 mg Abemaciclib + 10 mg/kg Ramucirumab Day 1
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG006
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG007
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG008
Part D: 100 mg Abemaciclib + 100 mg LY3023414
100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG009
Part D: 150 mg Abemaciclib + 100 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG010
Part D: 150 mg Abemaciclib + 150 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG011
Part D: 200 mg Abemaciclib + 150 mg LY3023414
200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG012
Part D: 150 mg Abemaciclib + 200 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG013
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab
100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG014
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG0008
OG00115
OG0023
OG00321
OG0044
OG00519
OG00612
OG0074
OG0083
OG0099
OG01010
OG0116
OG0128
OG0133
OG01417
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0041
OG0051
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
OG0130
OG0142
OG001
Part B: Abemaciclib + 1250 mg/m^2 Gemcitabine
150/200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part C:Abemaciclib+ 8/10mg/kg Ramucirumab Day1/8
150 /200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg /10 mg/kg ramucirumab / given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG003
Part D: Abemaciclib + 100 mg/150 mg/ 200 mg LY3023414
100 mg/ 150 mg / 200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg / 150 mg/ 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG004
Part E: 100 mg/150 mg Abemaciclib + 200 mg Pembrolizumab
100 mg / 150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG00023
OG00124
OG00239
OG00336
OG00420
Title
Denominators
Categories
Title
Measurements
OG0005.55(1.81 to 22.47)
OG0011.58(1.18 to 2.46)
OG0024.83(1.61 to 7.16)
OG0031.87(1.41 to 5.32)
OG0044.11(3.02 to NA)The upper limit of the 95% confidence Interval (CI) was not calculated due to the high censoring rate.
OG001
Part A: 200 mg Abemaciclib + 500 mg/m^2 Pemetrexed
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 500 mg/m^2 pemetrexed given intravenously (IV) over approximately 10 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG002
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG003
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG004
Part C:150 mg Abemaciclib+10mg/kg Ramucirumab Day1
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG005
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG006
Part C: 150 mg Abemaciclib + 8 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 8 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG007
Part C: 150 mg Abemaciclib + 10 mg/kg Ramucirumab Days 1 and 8
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 mg/kg ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG008
Part D: 100 mg Abemaciclib + 100 mg LY3023414
100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG009
Part D: 150 mg Abemaciclib + 100 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG010
Part D: 150 mg Abemaciclib + 150 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG011
Part D: 200 mg Abemaciclib + 150 mg LY3023414
200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG012
Part D: 150 mg Abemaciclib + 200 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG013
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab
100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG014
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG0008
OG00115
OG0022
OG00321
OG0044
OG00519
OG00612
OG0074
OG0083
OG0099
OG01010
OG0116
OG0128
OG0133
OG01417
Title
Denominators
Categories
Mean core symptom severity
ParticipantsOG0006
ParticipantsOG00112
ParticipantsOG0021
ParticipantsOG00314
ParticipantsOG0042
ParticipantsOG00512
ParticipantsOG0069
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0107
ParticipantsOG0113
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG01413
Title
Measurements
OG000-0.16(-1.46 to 0.31)
OG0010.89(-0.96 to 2.24)
OG002-0.54(-0.54 to -0.54)
OG003
Mean symptom severity
ParticipantsOG0006
ParticipantsOG00112
ParticipantsOG0021
ParticipantsOG00314
Mean lung cancer symptom
ParticipantsOG0006
ParticipantsOG00112
ParticipantsOG0021
ParticipantsOG00312
Mean interference severity
ParticipantsOG0006
ParticipantsOG00112
ParticipantsOG0021
ParticipantsOG00312
Part B: 150 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG003
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG004
Part C: 150 mg Abemaciclib + 8 mg/kg or 10 mg/kg Ramucirumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1, or 8 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8, or 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG005
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day 1
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG006
Part D: 100 mg Abemaciclib + 100 mg LY3023414
100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG007
Part D: 150 mg Abemaciclib + 100 or 150 or 200 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 or 150 or 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG008
Part D: 200 mg Abemaciclib + 150 mg LY3023414
200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG009
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab
100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG010
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG0008
OG00115
OG0023
OG00320
OG00420
OG00519
OG0063
OG00727
OG0086
OG0093
OG01017
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG00115
ParticipantsOG0023
ParticipantsOG00320
ParticipantsOG00420
ParticipantsOG00519
ParticipantsOG0063
ParticipantsOG00727
ParticipantsOG0086
ParticipantsOG0093
ParticipantsOG01017
Title
Measurements
OG000114± 67.4
OG001212± 79.8
OG00280.6± 14.7
OG003
Steady State
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0022
ParticipantsOG0033
Participants
OG0007
OG00112
Title
Denominators
Categories
Title
Measurements
OG00098.1± 29
OG00193.5± 30
OG002
Part B: 200 mg or MTD Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib or maximum tolerated dose (MTD) under the combination treatment abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG0003
OG0014
OG00216
Title
Denominators
Categories
Day 1
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG00216
Title
Measurements
OG00035600± 14
OG00149600± 12
OG00241900± 21
Steady State
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0028
Title
Measurements
OG000
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG003
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG00012
OG0014
OG0024
OG00318
Title
Denominators
Categories
C1D1
ParticipantsOG00012
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG00318
Title
Measurements
OG000174± 19.6
OG001226± 10.0
OG002193± 27.0
OG003
C2D1
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0037
Units
Counts
Participants
OG00012
OG00115
OG0028
Title
Denominators
Categories
Day 1
ParticipantsOG00012
ParticipantsOG00115
ParticipantsOG0028
Title
Measurements
OG000298± 104
OG001454± 81
OG002578± 119
Steady State
ParticipantsOG00012
ParticipantsOG0014
ParticipantsOG0021
Title
Measurements
OG000
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG003
Part B: 200 mg Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG004
Part C: 150 mg Abemaciclib + 8 mg/kg or 10 mg/kg Ramucirumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1, or 8 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8, or 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG005
Part C: 200 mg Abemaciclib + 10mg/kg Ramucirumab Day1
200 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Day 1 or 8 to 10 milligram/kilogram (mg/kg) ramucirumab given intravenously over approximately 60 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG006
Part D: 100 mg Abemaciclib + 100 mg LY3023414
100 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG007
Part D: 150 mg Abemaciclib + 100 or 150 or 200 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 100 or 150 or 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG008
Part D: 200 mg Abemaciclib + 150 mg LY3023414
200 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 150 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG009
Part E: 100 mg Abemaciclib + 200 mg Pembrolizumab
100 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
OG010
Part E: 150 mg Abemaciclib + 200 mg Pembrolizumab
150 mg abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg pembrolizumab given intravenously over approximately 30 minutes on day 1 of a 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG0008
OG00115
OG0023
OG00320
OG00420
OG00519
OG0063
OG00727
OG0086
OG0093
OG01017
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG00115
ParticipantsOG0023
ParticipantsOG00320
ParticipantsOG00420
ParticipantsOG00519
ParticipantsOG0063
ParticipantsOG00727
ParticipantsOG0086
ParticipantsOG0091
ParticipantsOG01017
Title
Measurements
OG000533± 69.6
OG001979± 77.5
OG002393± 31.0
OG003
Steady State
ParticipantsOG0001
ParticipantsOG0018
ParticipantsOG0021
ParticipantsOG0033
Counts
Participants
OG0007
OG00112
Title
Denominators
Categories
Title
Measurements
OG000201± 30
OG001198± 32
OG002
200 mg or MTD Abemaciclib + 1250 mg/m^2 Gemcitabine
200 mg abemaciclib or maximum tolerated dose (MTD) under the combination treatment abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 1250 mg/m^2 gemcitabine given intravenously over approximately 30 minutes on Days 1 and 8 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG0003
OG0014
OG00216
Title
Denominators
Categories
Day 1
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG00215
Title
Measurements
OG000175000± 16
OG001246000± 29
OG002198000± 26
Steady State
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0028
Title
Measurements
OG000
OG002
Part D: 150 mg Abemaciclib + 200 mg LY3023414
150 mg Abemaciclib given orally every 12 hours on Days 1 through 21 of a 21-day cycle in combination with 200 mg LY3023414 given orally every 12 hours on Days 1 through 21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Units
Counts
Participants
OG00012
OG00115
OG0028
Title
Denominators
Categories
Day 1
ParticipantsOG00012
ParticipantsOG00115
ParticipantsOG0028
Title
Measurements
OG0001005± 63
OG0011751± 56
OG0023809± 95
Steady State
ParticipantsOG00012
ParticipantsOG0014
ParticipantsOG0021
Title
Measurements
OG000
1 events
1 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
1 events
1 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
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21 at risk
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21 at risk
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21 at risk
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EG0121 events1 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
2 events
1 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0092 events2 affected9 at risk
EG0103 events2 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0101 events1 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected17 at risk
1 events
1 affected
21 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0103 events1 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0061 events1 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0063 events2 affected12 at risk
EG0072 events2 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected17 at risk
1 events
1 affected
21 at risk
EG0042 events1 affected4 at risk
EG0051 events1 affected19 at risk
EG0061 events1 affected12 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected9 at risk
EG0105 events5 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected17 at risk
0 events
0 affected
21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected8 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected17 at risk
-0.08
(-1.54 to 1.08)
OG004-0.35(-2.47 to 1.77)
OG0050.61(-1.04 to 2.70)
OG006-0.64(-1.54 to 1.23)
OG007-1.39(-2.31 to -0.46)
OG0080.61(-1.85 to 2.15)
OG0091.89(1.00 to 3.85)
OG0101.60(-1.15 to 2.77)
OG011-0.80(-2.93 to 0.38)
OG0120.28(-1.62 to 2.18)
OG0130.91(0.19 to 1.93)
OG0140.88(0.47 to 2.08)
ParticipantsOG0042
ParticipantsOG00512
ParticipantsOG0069
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0107
ParticipantsOG0113
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG01413
Title
Measurements
OG000-0.05(-1.43 to 0.68)
OG0010.83(-0.86 to 1.82)
OG002-0.44(-0.44 to -0.44)
OG003-0.03(-1.44 to 1.19)
OG004-0.41(-2.31 to 1.50)
OG0050.72(-0.88 to 2.41)
OG006-0.61(-1.25 to 1.06)
OG007-1.01(-2.13 to 0.12)
OG0080.64(-1.63 to 1.94)
OG0091.86(1.50 to 3.62)
OG0101.60(-0.94 to 2.88)
OG011-0.73(-2.82 to 0.37)
OG0120.19(-1.35 to 1.73)
OG0130.99(0.59 to 1.69)
OG0140.75(0.56 to 1.94)
ParticipantsOG0042
ParticipantsOG00513
ParticipantsOG0069
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0107
ParticipantsOG0113
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG01413
Title
Measurements
OG0001.22(-1.00 to 3.33)
OG0010.71(-1.00 to 1.00)
OG0021.67(1.67 to 1.67)
OG0030.19(-1.00 to 1.00)
OG004-0.67(-1.67 to 0.33)
OG0051.13(-1.00 to 2.00)
OG006-0.78(-3.00 to 0.67)
OG0073.01(2.67 to 3.34)
OG0080.78(-0.67 to 2.00)
OG0091.40(-0.34 to 2.66)
OG0102.19(0.67 to 3.33)
OG011-0.44(-2.33 to 1.34)
OG0120.67(-1.00 to 2.34)
OG0131.67(0.67 to 2.33)
OG0140.23(-1.00 to 1.67)
ParticipantsOG0042
ParticipantsOG00513
ParticipantsOG0069
ParticipantsOG0072
ParticipantsOG0083
ParticipantsOG0095
ParticipantsOG0107
ParticipantsOG0113
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG01413
Title
Measurements
OG0002.32(1.50 to 4.20)
OG0010.49(-3.00 to 3.59)
OG0020.00(0.00 to 0.00)
OG0030.95(-0.51 to 4.76)
OG004-1.33(-3.83 to 1.17)
OG0050.15(-3.00 to 3.16)
OG006-1.00(-5.16 to 1.33)
OG007-3.08(-4.50 to -1.66)
OG0080.72(-1.17 to 3.50)
OG0091.47(0.17 to 1.67)
OG0101.81(-0.83 to 5.17)
OG011-0.22(-3.17 to 2.17)
OG012-0.38(-4.25 to 3.50)
OG0131.44(0.33 to 2.83)
OG0141.00(-1.67 to 2.84)
201
± 71.7
OG004140± 95.7
OG005195± 85.8
OG00686.2± 91.1
OG007159± 74.1
OG008225± 103
OG009125± 57.2
OG010114± 68.8
Participants
OG004
11
ParticipantsOG0056
ParticipantsOG0063
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0093
ParticipantsOG01010
Title
Measurements
OG000NA± NANA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmax = 146 ng/mL and 183 ng/mL.
OG001509± 40.5
OG002NA± NANA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmax = 308 ng/mL and 606 ng/mL.
OG003417± 77.7
OG004322± 112
OG005228± 152
OG006227± 85.1
OG007305± 55.8
OG009270± 47.7
OG010240± 87.5
NA
± NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of Cmax = 33414 ng/mL, 49416 ng/mL.
OG00138700± 18
OG00235800± 17
221
± 30.6
Title
Measurements
OG000221± 15.0
OG001NA± NANA = Data reported as individual values when participants analyzed (n) were less than 3. Individual value of Cmax = 283 μg/mL and 264 μg/mL.
OG002NA± NAData reported as individual values when participants analyzed (n) were less than 3. Individual value of Cmax = 158 μg/mL.
OG003226± 32.3
438
± 63
OG001491± 52
OG002NA± NANA = Data reported as individual values when participants analyzed (n) were less than 3. Individual value of Cmax = 165 ng/mL.
886
± 53.4
OG004797± 69.0
OG0051030± 127
OG006394± 71.7
OG007719± 77.3
OG008967± 139
OG009NA± NANA = Data reported as individual values when participants analyzed (n) were less than 3. Individual value of AUC = 482 ng\*h/mL.
OG010518± 21.6
Participants
OG004
11
ParticipantsOG0056
ParticipantsOG0062
ParticipantsOG00710
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG01010
Title
Measurements
OG000NA± NANA = Data reported as individual values when participants analyzed (n) were less than 3. Individual value of AUC = 1350 ng\*h/mL.
OG0013710± 41.1
OG002NA± NANA = Data reported as individual values when participants analyzed (n) were less than 3. Individual value of AUC = 2270 ng\*h/mL.
OG0032690± 53.4
OG0041720± 119
OG0051840± 115
OG006NA± NANA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of AUC = 1030 ng\*h/mL and 1050 ng\*h/mL.
OG0071550± 83.7
OG0101400± 184
NA
± NA
NA = Data reported as individual values when participants analyzed (n) were less than 3. Individual values of AUC\[0-12h\] = 201000 ng\*h/mL and 249000 ng\*h/mL.
OG001208000± 20
OG002210000± 23
1303
± 64
OG0011293± 49
OG002NA± NANA = No participants had sufficient PK data to compute AUC0-tau.