A Study of Abemaciclib in Participants With Cancer That i... | NCT02688088 | Trialant
NCT02688088
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Oct 18, 2022Actual
Enrollment
48Actual
Phase
Phase 1
Conditions
Neoplasm Metastasis
Interventions
Drug Cocktail
Abemaciclib
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02688088
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15537
Secondary IDs
ID
Type
Description
Link
I3Y-MC-JPCB
Other Identifier
Eli Lilly and Company
Brief Title
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
Official Title
Effects of Multiple Doses of Abemaciclib on the Pharmacokinetics of Cytochrome P450 (CYP) 1A2, CYP2C9, CYP2D6, and CYP3A Substrates (Caffeine, Warfarin, Dextromethorphan, and Midazolam) in Cancer Patients
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Apr 1, 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03763604Approved for marketing
Start Date
Mar 8, 2016Actual
Primary Completion Date
Feb 4, 2018Actual
Completion Date
Jan 6, 2021Actual
First Submitted Date
Feb 17, 2016
First Submission Date that Met QC Criteria
Feb 17, 2016
First Posted Date
Feb 23, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 1, 2022
Results First Submitted that Met QC Criteria
Apr 1, 2022
Results First Posted Date
Oct 18, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 1, 2022
Last Update Posted Date
Oct 18, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
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
This study is known as a "drug interaction study" and is being done to see how abemaciclib may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin, dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant will complete screening and four study periods in a fixed sequence, with the option to continue to receive abemaciclib in a safety extension phase. All participants will complete a safety follow-up.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasm Metastasis
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
48Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Drug Cocktail - Period 1
Active Comparator
Single dose of drug cocktail: 100 milligram (mg) caffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
Drug: Drug Cocktail
200 mg Abemaciclib + Drug Cocktail - Period 2
Experimental
200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 - 12 in Period 2 with a single dose of drug cocktail: 100 mgcaffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
Drug: Drug Cocktail
Drug: Abemaciclib
200 mg Abemaciclib - Period 3
Experimental
200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3. Participants may continue to receive abemaciclib until discontinuation criteria are met.
Drug: Abemaciclib
200 mg Abemaciclib - Period 4
Experimental
200 mg Abemaciclib administered orally Q12H on Days 1 to 28 in Period 4. Participants may continue to receive abemaciclib until discontinuation criteria are met.
Drug: Abemaciclib
Safety Extension Period
Experimental
200 mg Abemaciclib administered orally Q12H on Days 1 to 28 onwards in extension period. Participants may continue to receive abemaciclib until discontinuation criteria are met.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Drug Cocktail
Drug
Administered orally
200 mg Abemaciclib + Drug Cocktail - Period 2
Drug Cocktail - Period 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine
Maximum concentration of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours (hr) Postdose
Pharmacokinetics: Maximum Concentration (Cmax) S-Warfarin
Maximum concentration of S-warfarin after single dose of drug cocktail on Day 1 in Period 1and in combination with Abemaciclib on Day 8 in Period 2.
Days 1 and 8: Predose, 0.5 1, 2, 3, 4, 6, 8, 12, 48, 72, 96 hr Postdose
Pharmacokinetics: Maximum Concentration (Cmax) of Dextromethorphan
Maximum concentration of dextromethorphan after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Days 1 and 8: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72 hr postdose
Pharmacokinetics: Maximum Concentration (Cmax) of Midazolam
Maximum concentration of midazolam after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Caffeine
PK: AUC zero to infinity of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hr Postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of S-Warfarin
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 1
Mean change from predose in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose drug cocktail in Period 1.
Day 8: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic
Have adequate organ function
Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, cancer-related hormone therapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug and have recovered from the acute effects of therapy(treatment related toxicity resolved to baseline), except for residual alopecia
Exclusion Criteria:
Require treatment with inducers or inhibitors of cytochrome P450 (CYP)1A2, CYP2C9, CYP2D6, and CYP3A within 14 days before the first dose of study drug through the end of Period 2
History or presence of significant bleeding disorders
Have known active uncontrolled or symptomatic CNS metastases
Have a primary liver tumor
Have lymphoma or leukemia
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)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sarah Cannon Research Institute at HealthOne
Denver
Colorado
80218
United States
IU Simon Cancer Center
References Module
Citations
Not provided
See Also Links
Label
URL
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
Abemaciclib dose adjustments were allowed due to drug-related toxicity. Before the start of each cycle, drug-related toxicities must have resolved to either baseline or at least Grade 2. Participants not recovered from toxicities within 14 days were discontinued from the study. For Period 2, if abemaciclib dose adjustments occurred, dosing with the drug cocktail was permitted to be delayed to allow for adequate exposure.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Drug Cocktail - Period 1
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
AUC (zero to infinity) of S-warfarin after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hr Postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Dextromethorphan
PK: AUC (zero to infinity) of dextromethorphan after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Days 1 and 8: 1, 2, 4, 6, 8, 10, 24, 48, 72 hr Postdose
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Midazolam
PK: AUC (zero to infinity) of midazolam after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 1.
Day 8: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Mean change from baseline in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose of abemaciclib in Period 2, Day 1.
Day 1: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 2, Day 1.
Day 1: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Mean change from baseline in systolic and diastolic blood pressure (BP) at 24 h postdose following 200 mg abemaciclib and drug cocktail.
Day 8: Baseline, 24 h postdose
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
Mean change from baseline in pulse rate at 24 h postdose following 200 mg abemaciclib and drug cocktail.
Day 8: Baseline, 24 h postdose
Indianapolis
Indiana
46202
United States
University of Kansas Hospital
Fairway
Kansas
66160
United States
Mary Crowley Cancer Research Center
Dallas
Texas
75230
United States
South Texas Accelerated Research Therapeutics, LCC
San Antonio
Texas
78229-3307
United States
200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
FG002
200 mg Abemaciclib - Period 3
200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3.
.
FG003
200 mg Abemaciclib Period - 4
200 mg Abemaciclib administered orally Q12H on Days 1 to 28 in Period 4.
FG004
Abemaciclib Safety Extension Period
200 mg Abemaciclib administered orally Q12H on Days 1 to 28 onwards in extension period.
FG00044 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Received One Dose of Drug Cocktail
FG00044 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00044 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Abemaciclib + Drug Cocktail - Period 2
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants received Drug Cocktail in Period 1 only.
FG00144 subjectsParticipants entered Period 2 to receive Abemaciclib on Days 1 to 12 and Drug Cocktail on Day 8.
FG0020 subjects
FG0030 subjects
FG0040 subjects
Received at Least One Dose of Study Drug
FG0000 subjects
FG00142 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG00137 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Abemaciclib Days 13 to 28 - Period 3
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjectsParticipants completed Period 2.
FG00237 subjectsParticipants continue Abemaciclib in Period 3.
FG0030 subjects
FG0040 subjects
Received at Least One Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG00236 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00229 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0028 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG003
Abemaciclib Days 1 to 28 - Period 4
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjectsParticipants completed Abemaciclib Period 3.
FG00329 subjectsParticipants continued to receive Abemaciclib in Period 4.
FG0040 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00321 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Abemaciclib Safety Extension Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjectsParticipants completed Period 4.
FG00418 subjectsParticipants had option of continuing Abemaciclib in Safety Extension Period.
Received at Least One Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Met Discontinuation Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All participants who received at least one dose of drug cocktail.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Overall
A single dose of drug cocktail was administered on Day 1 of Period 1. Abemaciclib 200 mg was administered Q12H starting on Day 1 of Period 2 with coadministration of drug cocktail on Day 8. Participants continued to receive 200 mg abemaciclib (or modified dose as required) Q12H up to 16 days in Period 3 and up to 28 days in Period 4. Participants could participate in a safety extension phase in which they received 200 mg abemaciclib (or modified dose as required) Q12H until discontinuation criteria are met.
Denominators
Units
Counts
Participants
BG00044
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
BG00060.1± 11.0
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00020
Male
BG00024
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
Not Hispanic or Latino
BG00041
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
Asian
BG0001
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG00044
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
Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine
Maximum concentration of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours (hr) Postdose
ID
Title
Description
OG000
100 mg Caffeine
Single oral dose of 100 mg caffeine administered orally on Day 1 in Period 1.
OG001
Abemaciclib + 100 mg Caffeine
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
Units
Counts
Participants
OG00039
OG00132
Title
Denominators
Categories
Title
Measurements
OG0002890± 29
OG0012950± 33
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ratio of Geometric LS Means
1.01
2-Sided
90
0.965
1.06
Superiority
Primary
Pharmacokinetics: Maximum Concentration (Cmax) S-Warfarin
Maximum concentration of S-warfarin after single dose of drug cocktail on Day 1 in Period 1and in combination with Abemaciclib on Day 8 in Period 2.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Days 1 and 8: Predose, 0.5 1, 2, 3, 4, 6, 8, 12, 48, 72, 96 hr Postdose
ID
Title
Description
OG000
10 mg Warfarin
10 mg warfarin administered orally on Day 1 in Period 1.
OG001
200 mg Abemaciclib + 10 mg Warfarin
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
Units
Counts
Participants
OG000
Primary
Pharmacokinetics: Maximum Concentration (Cmax) of Dextromethorphan
Maximum concentration of dextromethorphan after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Days 1 and 8: Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72 hr postdose
ID
Title
Description
OG000
30 mg Dextromethorphan
30 mg dextromethorphan administered orally on Day 1 in Period 1.
OG001
200 Abemaciclib + 30 mg Dextromethorphan
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
Units
Counts
Participants
OG000
Primary
Pharmacokinetics: Maximum Concentration (Cmax) of Midazolam
Maximum concentration of midazolam after single dose of drug cocktail on Day 1 of Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
All subjects who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose
ID
Title
Description
OG000
0.2 mg Midazolam (Drug Cocktail)
Single dose of 0.2 mg midazolam administered orally on Day 1 in Period 1.
OG001
200 mg Abemaciclib + 0.2 mg Midazolam
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
Units
Counts
Participants
OG000
Primary
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Caffeine
PK: AUC zero to infinity of caffeine after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Least Squares Mean
Geometric Coefficient of Variation
nanograms*hour per milliliter (ng*h/mL)
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hr Postdose
ID
Title
Description
OG000
100 mg Caffeine
Single dose of 100 mg caffeine administered orally on Day of Period 1.
OG001
200 mg Abemaciclib + 100 mg Caffeine
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
Units
Counts
Participants
OG000
Primary
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of S-Warfarin
AUC (zero to infinity) of S-warfarin after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hr Postdose
ID
Title
Description
OG000
10 mg Warfarin
Single dose 10 mg warfarin administered orally on Day of Period 1.
OG001
200 mg Abemaciclib + 10 mg Warfarin
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
Units
Counts
Participants
OG000
Primary
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Dextromethorphan
PK: AUC (zero to infinity) of dextromethorphan after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Days 1 and 8: 1, 2, 4, 6, 8, 10, 24, 48, 72 hr Postdose
ID
Title
Description
OG000
30 mg Dextromethorphan
Single dose 30 mg administered orally on Day 1 of Period 1.
OG001
200 mg Abemaciclib + 30 mg Dextromethorphan
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
Units
Counts
Participants
OG000
Primary
Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Midazolam
PK: AUC (zero to infinity) of midazolam after single dose of drug cocktail on Day 1 in Period 1 and in combination with Abemaciclib on Day 8 in Period 2.
All participants who received at least one dose of study drug and had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Days 1 and 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hr Postdose
ID
Title
Description
OG000
0.2 mg Midazolam
Single dose 0.2 mg midazolam administered orally on Day 1 of Period 1.
OG001
200 mg Abemaciclib + 0.2 mg Midazolam
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
Units
Counts
Participants
OG000
Secondary
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 1
Mean change from predose in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose drug cocktail in Period 1.
All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Posted
Mean
Standard Deviation
millimeter of mercury (mmHg)
Day 8: Baseline, 24 h postdose
ID
Title
Description
OG000
Drug Cocktail Period 1
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
Units
Counts
Participants
OG000
Secondary
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 1
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 1.
All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Posted
Mean
Standard Deviation
Beats per minute (bpm)
Day 8: Baseline, 24 h postdose
ID
Title
Description
OG000
Drug Cocktail Period 1
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
Units
Counts
Participants
OG000
Secondary
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Mean change from baseline in systolic and diastolic blood pressure (BP) over 24 hours (h) postdose following single dose of abemaciclib in Period 2, Day 1.
All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Posted
Mean
Standard Deviation
mmHg
Day 1: Baseline, 24 h postdose
ID
Title
Description
OG000
200 mg Abemaciclib
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Units
Counts
Participants
OG000
Secondary
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
Mean change from baseline in pulse rate over 24 hours (h) postdose following single dose drug cocktail in Period 2, Day 1.
All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Posted
Mean
Standard Deviation
bpm
Day 1: Baseline, 24 h postdose
ID
Title
Description
OG000
200 mg Abemaciclib
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Units
Counts
Participants
OG00041
Secondary
Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2
Mean change from baseline in systolic and diastolic blood pressure (BP) at 24 h postdose following 200 mg abemaciclib and drug cocktail.
All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Posted
Mean
Standard Deviation
mmHg
Day 8: Baseline, 24 h postdose
ID
Title
Description
OG000
200 mg Abemaciclib + Drug Cocktail
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
Units
Counts
Participants
OG000
Secondary
Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2
Mean change from baseline in pulse rate at 24 h postdose following 200 mg abemaciclib and drug cocktail.
All subjects who received at least one dose of study drug and had at least one postdose safety assessment.
Posted
Mean
Standard Deviation
bpm
Day 8: Baseline, 24 h postdose
ID
Title
Description
OG000
200 mg Abemaciclib + Drug Cocktail
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2.
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8.
Units
Counts
Participants
OG000
Time Frame
Baseline up to 46 days
Description
All participants who received at least one dose of study drug and have at least one postdose safety assessment.
As dose adjustments due to toxicity were allowed in Periods 2, 3, and 4, a participant may have entered Period 3 or 4 on a dose level other than 200 mg Abemaciclib. As a result, the number of participants for Periods 3 and 4 differ between the Participant Flow and the Adverse Events section.
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
Drug Cocktail - Period 1
Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.
1
44
1
44
22
44
EG001
200 mg Abemaciclib - Period 2
200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 to 12 in Period 2.
0
42
3
42
33
42
EG002
200 mg Abemaciclib + Drug Cocktail - Period 2
200 mg Abemaciclib administered orally Q12H on Days 1 to 12 in Period 2. Single dose of drug cocktail: 100 mg caffeine, 10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.
0
35
2
35
26
35
EG003
200 mg Abemaciclib - Periods 3 and 4
200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3, and Days 1 to 28 in Period 4.
0
28
6
28
25
28
EG004
Abemaciclib Safety Extension Period
200 mg Abemaciclib administered orally Q12H until discontinuation criteria are met.
0
18
2
18
16
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected35 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected18 at risk
Ascites
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected35 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Medical device complication
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Sepsis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Platelet count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected35 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0022 events2 affected35 at risk
EG0036 events6 affected28 at risk
EG0042 events2 affected18 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Vision blurred
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected44 at risk
EG0016 events6 affected42 at risk
EG0022 events2 affected35 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0012 events2 affected42 at risk
EG0022 events2 affected35 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected44 at risk
EG0013 events3 affected42 at risk
EG0024 events4 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG00118 events18 affected42 at risk
EG00211 events11 affected35 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected42 at risk
EG0022 events2 affected35 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected35 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0005 events5 affected44 at risk
EG0019 events8 affected42 at risk
EG0026 events6 affected35 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0003 events2 affected44 at risk
EG0019 events8 affected42 at risk
EG0027 events5 affected35 at risk
EG003
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0016 events6 affected42 at risk
EG0026 events6 affected35 at risk
EG003
Gait disturbance
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Local swelling
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Oedema
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0012 events2 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Portal vein stenosis
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected44 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected44 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0014 events4 affected42 at risk
EG0020 events0 affected35 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0007 events7 affected44 at risk
EG0012 events2 affected42 at risk
EG0023 events3 affected35 at risk
EG003
Lipase increased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Platelet count decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Weight decreased
Investigations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0014 events3 affected42 at risk
EG0024 events4 affected35 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected44 at risk
EG0013 events3 affected42 at risk
EG0025 events4 affected35 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0016 events5 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected35 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0002 events2 affected44 at risk
EG0012 events2 affected42 at risk
EG0021 events1 affected35 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected44 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected35 at risk
EG003
Salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)