Study of MK-8242 Alone and in Combination With Cytarabine... | NCT01451437 | Trialant
NCT01451437
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Aug 27, 2018Actual
Enrollment
26Actual
Phase
Phase 1
Conditions
Acute Myelogenous Leukemia (AML)
Interventions
MK-8242
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01451437
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P07649
Secondary IDs
ID
Type
Description
Link
2011-000709-31
EudraCT Number
MK-8242-005
Other Identifier
Merck study number
Brief Title
Study of MK-8242 Alone and in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia (P07649)
Official Title
A Phase I Study to Evaluate the Safety and Tolerability and Pharmacokinetic/Pharmacodynamics of MK-8242 Administered Alone and in Combination With Chemotherapy in Subjects With Refractory or Recurrent Acute Myelogenous Leukemia (Protocol No. P07649 (005))
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jul 2018
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated early due to business reasons.
Expanded Access Info
No
Start Date
Nov 18, 2011Actual
Primary Completion Date
Sep 5, 2014Actual
Completion Date
Sep 5, 2014Actual
First Submitted Date
Oct 11, 2011
First Submission Date that Met QC Criteria
Oct 11, 2011
First Posted Date
Oct 13, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 5, 2016
Results First Submitted that Met QC Criteria
Feb 5, 2016
Results First Posted Date
Mar 4, 2016Estimated
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
Jul 26, 2018
Last Update Posted Date
Aug 27, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
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 is a study of MK-8242 alone and in combination with cytarabine in adult participants with refractory or recurrent acute myelogenous leukemia (AML). The study will have 2 Arms. Arm A is for participants with refractory or recurrent AML who are considered ineligible for standard chemotherapy. In Part 1 of Arm A, participants will receive MK-8242 monotherapy in escalating doses to determine the recommended phase 2 dose [RP2D]. In Part 2, participants will receive monotherapy with MK-8242 to confirm the RP2D and assess preliminary efficacy. Arm B is for participants with recurrent AML following an initial complete remission (CR) or CR with incomplete marrow recovery (CRi) of 6 to 12 months duration. In Part 1 of Arm B, participants will receive MK-8242 in escalating doses + cytarabine to determine the RP2D in combination with cytarabine. In Part 2, participants will receive MK-8242 + cytarabine to confirm the RP2D and assess preliminary efficacy. The pharmacokinetics of MK-8242 will be studied in both arms. With Amendment 4 (22 August 2013) a 21-day dosing cycle is added, with MK-8242 being given on Days 1-7 of each 21-day cycle in both the monotherapy and combination therapy arms; data from Arm A will be used to determine whether a participant receives 21-day or 28-day therapy in Arm B.
Detailed Description
Not provided
Conditions Module
Conditions
Acute Myelogenous Leukemia (AML)
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
26Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pt 1 Arm A: MK-8242 30 mg QD
Experimental
Participants received MK-8242 30 mg once daily (QD) monotherapy on Days 1-7 and Days 15-21 of a 28-day cycle up to a maximum of 12 cycles in Part 1 Arm A.
Drug: MK-8242
Pt 1 Arm A: MK-8242 60 mg QD
Experimental
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of a 28-day cycle up to a maximum of 12 cycles in Part 1 Arm A.
Drug: MK-8242
Pt 1 Arm A: MK-8242 120 mg QD
Experimental
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of a 28-day cycle up to a maximum of 12 cycles in Part 1 Arm A.
Drug: MK-8242
Pt 1 Arm A: MK-8242 250 mg QD
Experimental
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of a 28-day cycle up to a maximum of 12 cycles in Part 1 Arm A.
Drug: MK-8242
Pt 1 Arm A: MK-8242 120 mg BID
Experimental
Participants received MK-8242 120 mg twice daily (BID) monotherapy on Days 1-7 and Days 15-21 of a 28-day cycle up to a maximum of 12 cycles (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-8242
Drug
MK-8242 capsules, orally, once per day on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7) up to a maximum of 12 cycles. Starting dose will be 30 mg and will be escalated in successive cohorts until maximum tolerated dose (MTD) is established. Beginning at a dose level of ≥120 mg total daily dose (TDD), the dosing regimen will switch to twice daily (BID). Amendment 4 added a 21-day dosing cycle in which MK-8242 would be given BID on Days 1-7 of each cycle, at the assigned dose level.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were identified using Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 for toxicities attributable to the study drug. Hematologic DLTs were defined in the absence of morphological evidence of acute leukemia in the marrow if 1) bone marrow: aplastic marrow with <5% cellularity without erythroid, myeloid, or megakaryocytic precursors and 2) peripheral blood: absolute neutrophil count (ANC) <100/µL, platelet count <10,000/µL, and transfusion-dependent anemia. Non-hematologic DLTs were defined as any ≥Grade 3 toxicity with the following exceptions/clarifications: 1) infection, fatigue, anorexia, or alopecia are not included in determination of the DLT 2) Grade 3 nausea, vomiting, diarrhea, or dehydration occurring in a setting of inadequate treatment 3) any abnormal non-hematological laboratory value ≥Grade 3 will be considered a DLT after 72 hours of appropriate medical intervention if not related to an underlying disease or not attributable to another event.
Up to 28 days (Cycle 1) for non-hematologic toxicities and 42 days (Cycle 1) for hematologic toxicities
Number of Participants With Complete Remission (CR) at RP2D
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
End of Treatment (up to 198 days)
Number of Participants With Complete Remission With Incomplete Marrow Recovery (CRi) at RP2D
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
End of Treatment (up to 198 days)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With CR at Dose Levels Other Than RP2D
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at dose levels other than RP2D. CR is defined as a morphologic leukemia-free state with a neutrophil count ≥1,000/µL, a platelet count ≥100,000/µL, no extramedullary disease, and RBC transfusion independence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
For Arm A Part 1 (monotherapy/dose escalation): refractory or recurrent AML, not an appropriate candidate for standard therapy
For Arm A Part 2 (monotherapy/dose confirmation/cohort expansion): refractory or recurrent AML, not an appropriate candidate for standard therapy, and have wild type p53 gene mutation analysis
For Arm B Part 1 (combination therapy/dose escalation): recurrent AML having achieved an initial CR or CRi of 6-12 months duration and age ≥18 years old and <70 years old
For Arm B Part 2 (combination therapy/dose confirmation/cohort expansion): recurrent AML having achieved an initial CR or CRi of 6-12 months duration, age ≥18 years old and <70 years old, and have wild type P53 gene mutation analysis
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 for all Arm A, or 0 or 1 for all Arm B
Negative pregnancy test within 72 hours of the first dose of study medication
Female participants and male participants and their partners who are of childbearing potential must agree to abstain from sexual intercourse or to use an acceptable method of contraception during the study and for 90 days following the last dose of study therapy
Adequate organ function
Recovered from the effects of any prior surgery, radiotherapy or anti-neoplastic treatment, with the exception of alopecia
Must be able to swallow, retain, and absorb oral medications and oral nutrition
Must follow the appropriate washout period for prohibited treatments
For Arm A and B, Part 1 only: history of myelodysplastic syndrome (MDS)
For Arm A and B, Part 2: AML in the background of MDS may be included
Isolated extramedullary leukemia without also meeting bone marrow criteria for acute leukemia
AML blast crisis of chronic myelogenous leukemia (CML)
Bone marrow transplant with active graft-versus host disease (GVHD) or who receives immunosuppressive therapy
Uncontrolled active infection that requires systemic treatment
Clinically significant hepatitis at Screening, or hepatitis C antibody positive, hepatitis B surface antigen positive, or human immunodeficiency virus (HIV) seropositive
Persistent, unresolved, drug-related toxicity
Breast-feeding, pregnant, intends to become pregnant or intends to breast feed during the study or has a positive pregnancy test at Screening
A person participating in any other clinical study with a potentially therapeutic agent or who has received another investigational product within 5 half-lives (if the half-life is known) or 28 days (if the half-life is unknown) prior to Day 1 of cycle 1
A participant who, within the past 6 months, has had any of the following: myocardial infarction, coronary/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack, or uncontrolled seizure disorder (i.e., seizures within the past 6 months)
A participant who, at the time of Screening, presents with: unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality
Known bleeding disorder, e.g. hemophilia or disseminated intravascular coagulopathy or on anti-coagulation therapy
For Arm B only: Known hypersensitivity to cytarabine
Ravandi F, Gojo I, Patnaik MM, Minden MD, Kantarjian H, Johnson-Levonas AO, Fancourt C, Lam R, Jones MB, Knox CD, Rose S, Patel PS, Tibes R. A phase I trial of the human double minute 2 inhibitor (MK-8242) in patients with refractory/recurrent acute myelogenous leukemia (AML). Leuk Res. 2016 Sep;48:92-100. doi: 10.1016/j.leukres.2016.07.004. Epub 2016 Jul 25.
No participant in Part 1 received combination therapy (MK-8242 + cytarabine). Study Part 2 was not performed due to early termination of the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
FG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
FG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
FG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
FG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
FG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
FG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
FG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
FG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG0044 subjects
FG0053 subjects
FG0066 subjects
FG0073 subjects
FG0084 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
BG001
Pt 1 Arm A: MK-8242 60 mg QD
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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 (DLTs)
DLTs were identified using Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 for toxicities attributable to the study drug. Hematologic DLTs were defined in the absence of morphological evidence of acute leukemia in the marrow if 1) bone marrow: aplastic marrow with <5% cellularity without erythroid, myeloid, or megakaryocytic precursors and 2) peripheral blood: absolute neutrophil count (ANC) <100/µL, platelet count <10,000/µL, and transfusion-dependent anemia. Non-hematologic DLTs were defined as any ≥Grade 3 toxicity with the following exceptions/clarifications: 1) infection, fatigue, anorexia, or alopecia are not included in determination of the DLT 2) Grade 3 nausea, vomiting, diarrhea, or dehydration occurring in a setting of inadequate treatment 3) any abnormal non-hematological laboratory value ≥Grade 3 will be considered a DLT after 72 hours of appropriate medical intervention if not related to an underlying disease or not attributable to another event.
DLT-evaluable Population: participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 or discontinued due to reason of toxicity.
Posted
Number
Participants
Up to 28 days (Cycle 1) for non-hematologic toxicities and 42 days (Cycle 1) for hematologic toxicities
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to approximately 7.6 months
Description
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
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
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Canada
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D015470
Leukemia, Myeloid, Acute
Ancestor Terms
ID
Term
D007951
Leukemia, Myeloid
D007938
Leukemia
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
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: MK-8242
Pt 1 Arm A: MK-8242 170 mg BID
Experimental
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of a 28-day cycle up to a maximum of 12 cycles (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
Drug: MK-8242
Pt 1 Arm A: MK-8242 210 mg BID
Experimental
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of a 21-day cycle up to a maximum of 12 cycles (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
Drug: MK-8242
Pt 1 Arm A: MK-8242 250 mg BID
Experimental
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of a 28-day cycle up to a maximum of 12 cycles (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
Drug: MK-8242
Pt 1 Arm A: MK-8242 300 mg BID
Experimental
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of a 21-day cycle up to a maximum of 12 cycles (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Drug: MK-8242
Pt 1 Arm A: MK-8242 120 mg BID
Pt 1 Arm A: MK-8242 120 mg QD
Pt 1 Arm A: MK-8242 170 mg BID
Pt 1 Arm A: MK-8242 210 mg BID
Pt 1 Arm A: MK-8242 250 mg BID
Pt 1 Arm A: MK-8242 250 mg QD
Pt 1 Arm A: MK-8242 30 mg QD
Pt 1 Arm A: MK-8242 300 mg BID
Pt 1 Arm A: MK-8242 60 mg QD
SCH 900242
End of Treatment (up to 198 days)
Number of Participants With CRi at Dose Levels Other Than RP2D
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at dose levels other than RP2D. CRi is defined as fulfillment of all CR criteria with exceptions for residual neutropenia (<1,000/µL), thrombocytopenia (<100,000/µL), and RBC transfusion dependence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
End of Treatment (up to 198 days)
Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24hr) for MK-8242 Alone and in Combination With Cytarabine
AUC(0-24hr) defined as AUC from time zero to 24 hours was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. For the BID arms, a projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 24 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], and 24 [Day 7 only] hrs postdose)
Area Under the Concentration-time Curve From Time 0 to Last (AUC0-last) for MK-8242 Alone and in Combination With Cytarabine
AUC(0-last) defined as AUC from time zero to the time of last quantifiable sample was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for MK-8242 Alone and in Combination With Cytarabine
AUC0-∞ defined as AUC from time zero to infinity was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax (condition not met for 60 QD and 120 BID dose groups). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)
Maximum Plasma Concentration (Cmax) of MK-8242 Alone and in Combination With Cytarabine
Cmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)
Time to Maximum Concentration (Tmax) of MK-8242 Alone and in Combination With Cytarabine
Tmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)
Apparent Terminal Half-life (t1/2) for MK-8242 Alone and in Combination With Cytarabine
Elimination phase t1/2 was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)
Accumulation Ratio (R) of MK-8242 Alone and in Combination With Cytarabine
The accumulation ratio (R) at steady state (based on dosing interval and apparent terminal half-life (t1/2)) for MK-8242 alone was not determined due to confounding of results by significant concentrations of a drug metabolite (M16). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Urine Concentration of MK-8242 (Part 2 Arm A Only)
The urine concentration of MK-8242 assessed as a measure of drug bioavailability was not determined due to early termination of the study (Study Part 2 was not performed).
Day 1 (predose and postdose) and Day 7 (postdose)
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
4 subjects
FG0053 subjects
FG0066 subjects
FG0073 subjects
FG0084 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0072 subjects
FG0081 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Disease Progression
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0043 subjects
FG0052 subjects
FG0063 subjects
FG0071 subjects
FG0083 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
BG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
BG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
BG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
BG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
BG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
BG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
BG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
BG009
Total
Total of all reporting groups
1
BG0011
BG0023
BG0031
BG0044
BG0053
BG0066
BG0073
BG0084
BG00926
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00063.0± NAnot calculated for n=1
BG00174.0± NAnot calculated for n=1
BG00272.3± 6.7
BG00377.0± NAnot calculated for n=1
BG00458.8± 18.5
BG00563.3± 14.6
BG00663.5± 11.5
BG00772.3± 12.5
BG00841.0± 14.3
BG00962.2± 15.5
Age, Customized
Number
Participants
Title
Denominators
Categories
Adults between 18 and 64 years
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0042
BG0051
BG0063
BG0071
BG0084
BG00912
From 65 to 84 years
Title
Measurements
BG0000
BG0011
BG0023
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
BG0063
BG0070
BG0081
BG0096
Male
BG0001
BG0011
BG0022
BG0031
BG004
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0091
Black or African American
Title
Measurements
BG0000
BG0010
BG0020
BG003
White
Title
Measurements
BG0001
BG0011
BG0023
BG003
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Hispanic Or Latino
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0091
Not Hispanic Or Latino
Title
Measurements
BG0001
BG0011
BG0023
BG003
Not Reported
Title
Measurements
BG0000
BG0010
BG0020
BG003
Unknown
Title
Measurements
BG0000
BG0010
BG0020
BG003
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0031
OG0044
OG0053
OG0066
OG0073
OG0084
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0072
OG0080
Primary
Number of Participants With Complete Remission (CR) at RP2D
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
Full Analysis Set for Efficacy: all participants with confirmed p53 wild type (WT) status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.
Posted
End of Treatment (up to 198 days)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Complete Remission With Incomplete Marrow Recovery (CRi) at RP2D
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.
Posted
End of Treatment (up to 198 days)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants With CR at Dose Levels Other Than RP2D
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at dose levels other than RP2D. CR is defined as a morphologic leukemia-free state with a neutrophil count ≥1,000/µL, a platelet count ≥100,000/µL, no extramedullary disease, and RBC transfusion independence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.
Posted
Number
Participants
End of Treatment (up to 198 days)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants With CRi at Dose Levels Other Than RP2D
Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at dose levels other than RP2D. CRi is defined as fulfillment of all CR criteria with exceptions for residual neutropenia (<1,000/µL), thrombocytopenia (<100,000/µL), and RBC transfusion dependence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.
Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.
Posted
Number
Participants
End of Treatment (up to 198 days)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24hr) for MK-8242 Alone and in Combination With Cytarabine
AUC(0-24hr) defined as AUC from time zero to 24 hours was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. For the BID arms, a projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-24hr) at the time of assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*nM
Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 24 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], and 24 [Day 7 only] hrs postdose)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Day 1 (n=1,1,3,1,3,2,4,3,1)
Title
Measurements
OG000604± NAn/a: not calculated for n=1
OG001510± NAn/a: not calculated for n=1
OG0023710± 126
Secondary
Area Under the Concentration-time Curve From Time 0 to Last (AUC0-last) for MK-8242 Alone and in Combination With Cytarabine
AUC(0-last) defined as AUC from time zero to the time of last quantifiable sample was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-last) at the time of assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*nM
Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Day 1
Title
Measurements
OG000323± NAn/a: not calculated for n=1
OG001482± NAn/a: not calculated for n=1
OG0023420± 156
Secondary
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for MK-8242 Alone and in Combination With Cytarabine
AUC0-∞ defined as AUC from time zero to infinity was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax (condition not met for 60 QD and 120 BID dose groups). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-∞) at the time of assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*nM
Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0001
OG0010
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG000650± NAn/a: not calculated for n=1
OG0023570± 61.6
OG0036990± NAn/a: not calculated for n=1
Secondary
Maximum Plasma Concentration (Cmax) of MK-8242 Alone and in Combination With Cytarabine
Cmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Cmax) at the time of assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Day 1 (n=1,1,3,1,4,3,5,3,3)
Title
Measurements
OG00056.7± NAn/a: not calculated for n=1
OG001109± NAn/a: not calculated for n=1
OG002416± 81.4
Secondary
Time to Maximum Concentration (Tmax) of MK-8242 Alone and in Combination With Cytarabine
Tmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Tmax) at the time of assessment.
Posted
Median
Full Range
Hours
Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Day 1 (n=1,1,3,1,4,3,5,3,3)
Title
Measurements
OG0006.25(NA to NA)n/a: not calculated for n=1
OG0012.00(NA to NA)n/a: not calculated for n=1
OG0024.00(2.08 to 4.05)
Secondary
Apparent Terminal Half-life (t1/2) for MK-8242 Alone and in Combination With Cytarabine
Elimination phase t1/2 was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (at least three time-points after Tmax).
Posted
Geometric Mean
Geometric Coefficient of Variation
hr
Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)
ID
Title
Description
OG000
Pt 1 Arm A: MK-8242 30 mg QD
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0001
OG0010
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.7± NAn/a: not calculated for n=1
OG0025.33± 23.5
OG0034.57± NAn/a: not calculated for n=1
Secondary
Accumulation Ratio (R) of MK-8242 Alone and in Combination With Cytarabine
The accumulation ratio (R) at steady state (based on dosing interval and apparent terminal half-life (t1/2)) for MK-8242 alone was not determined due to confounding of results by significant concentrations of a drug metabolite (M16). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).
Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (R) at the time of assessment.
Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
OG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
OG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
OG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
OG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
OG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Urine Concentration of MK-8242 (Part 2 Arm A Only)
The urine concentration of MK-8242 assessed as a measure of drug bioavailability was not determined due to early termination of the study (Study Part 2 was not performed).
Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (urine concentration) at the time of assessment
Posted
Day 1 (predose and postdose) and Day 7 (postdose)
ID
Title
Description
OG000
Pt 2 Arm A: MK-8242 30 mg QD
Participants to receive MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
OG001
Pt 2 Arm A: MK-8242 60 mg QD
Participants to receive MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
OG002
Pt 2 Arm A: MK-8242 120 mg QD
Participants to receive MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
OG003
Pt 2 Arm A: MK-8242 250 mg QD
Participants to receive MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
OG004
Pt 2 Arm A: MK-8242 120 mg BID
Participants to receive MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg to be administered QD in the morning) in Part 2 Arm A.
OG005
Pt 2 Arm A: MK-8242 170 mg BID
Participants to receive MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg to be administered QD in the morning) in Part 2 Arm A.
OG006
Pt 2 Arm A: MK-8242 210 mg BID
Participants to receive MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg to be administered QD in the morning) in Part 2 Arm A.
OG007
Pt 2 Arm A: MK-8242 250 mg BID
Participants to receive MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg to be administered QD in the morning) in Part 2 Arm A.
OG008
Pt 2 Arm A: MK-8242 300 mg BID
Participants to receive MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg to be administered QD in the morning) in Part 2 Arm A.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
1
1
1
1
EG001
Pt 1 Arm A: MK-8242 60 mg QD
Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
0
1
1
1
EG002
Pt 1 Arm A: MK-8242 120 mg QD
Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
2
3
3
3
EG003
Pt 1 Arm A: MK-8242 250 mg QD
Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
1
1
1
1
EG004
Pt 1 Arm A: MK-8242 120 mg BID
Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
1
4
4
4
EG005
Pt 1 Arm A: MK-8242 170 mg BID
Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
1
3
3
3
EG006
Pt 1 Arm A: MK-8242 210 mg BID
Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
5
6
6
6
EG007
Pt 1 Arm A: MK-8242 250 mg BID
Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
3
3
3
3
EG008
Pt 1 Arm A: MK-8242 300 mg BID
Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
2
4
3
4
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected3 at risk
EG0063 events2 affected6 at risk
EG0073 events3 affected3 at risk
EG0080 events0 affected4 at risk
Acute coronary syndrome
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Extrasystoles
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Pyrexia
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
Cellulitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Escherichia infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Lung infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Pneumonia
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Pneumonia fungal
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected3 at risk
EG0080 events0 affected4 at risk
Sepsis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Sinusitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Neuralgia
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
Confusional state
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Depression
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Suicide attempt
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Renal failure acute
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
Hypertension
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events2 affected3 at risk
EG0080 events0 affected4 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0082 events1 affected4 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0003 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0055 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
Palpitations
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Pericardial effusion
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Tachycardia
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Photophobia
Eye disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected4 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Constipation
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0053 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events2 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0052 events1 affected3 at risk
EG0062 events1 affected6 at risk
EG0076 events2 affected3 at risk
EG0083 events1 affected4 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Glossodynia
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Haematochezia
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Melaena
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Nausea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected1 at risk
EG0043 events2 affected4 at risk
EG0054 events1 affected3 at risk
EG0064 events4 affected6 at risk
EG0072 events2 affected3 at risk
EG0083 events2 affected4 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Tongue ulceration
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Vomiting
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG0033 events1 affected1 at risk
EG0042 events2 affected4 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected6 at risk
EG0074 events3 affected3 at risk
EG0083 events1 affected4 at risk
Asthenia
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Catheter site rash
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Chest pain
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Chills
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0073 events2 affected3 at risk
EG0080 events0 affected4 at risk
Fatigue
General disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected3 at risk
EG0031 events1 affected1 at risk
EG0041 events1 affected4 at risk
EG0052 events1 affected3 at risk
EG0061 events1 affected6 at risk
EG0073 events2 affected3 at risk
EG0081 events1 affected4 at risk
Infusion site erythema
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Malaise
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Mucosal inflammation
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Oedema
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Oedema peripheral
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0073 events2 affected3 at risk
EG0080 events0 affected4 at risk
Pain
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Pyrexia
General disorders
MedDRA 17.1
Systematic Assessment
EG0002 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Hypersensitivity
Immune system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Candida infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Fungal cystitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Gastrointestinal infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Gingivitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Oral candidiasis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Pneumonia
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Sunburn
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Blood bilirubin increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Blood creatinine decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Blood creatinine increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
Electrocardiogram QT prolonged
Investigations
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
International normalised ratio decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
International normalised ratio increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Platelet count decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Weight decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events2 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected6 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected4 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0042 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected6 at risk
EG0074 events1 affected3 at risk
EG0080 events0 affected4 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0074 events1 affected3 at risk
EG0083 events2 affected4 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0074 events2 affected3 at risk
EG0080 events0 affected4 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events1 affected3 at risk
EG0081 events1 affected4 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0053 events2 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
Leukaemia cutis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Balance disorder
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Depressed level of consciousness
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Dizziness
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Dizziness postural
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Dysgeusia
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Headache
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0072 events1 affected3 at risk
EG0081 events1 affected4 at risk
Syncope
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Agitation
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
Anxiety
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Delirium
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Depression
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0062 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Hallucination
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Insomnia
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Restlessness
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
Haematuria
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 affected4 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected4 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Mediastinal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0073 events1 affected3 at risk
EG0081 events1 affected4 at risk
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Vocal cord disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Blister
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected4 at risk
Purpura
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0072 events1 affected3 at risk
EG0080 events0 affected4 at risk
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0073 events1 affected3 at risk
EG0080 events0 affected4 at risk
Embolism
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Haematoma
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
Hypertension
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected3 at risk
EG0081 events1 affected4 at risk
Hypotension
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0073 events2 affected3 at risk
EG0080 events0 affected4 at risk
Orthostatic hypotension
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected4 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the Sponsor. The Investigator further agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.