A Phase I Study of MK-2206 in Combination With Standard C... | NCT00848718 | Trialant
NCT00848718
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 12, 2019Actual
Enrollment
77Actual
Phase
Phase 1
Conditions
Locally Advanced, Metastatic Solid Tumors
Interventions
MK-2206
docetaxel
erlotinib
carboplatin
paclitaxel
corticosteroid
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00848718
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2206-003
Secondary IDs
ID
Type
Description
Link
2009_547
MK-2206-003
Other Identifier
Merck
Brief Title
A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003)
Official Title
A Phase I Dose Escalation Study of MK-2206 in Combination With Standard Doses of Selected Chemotherapies or Targeted Agents in Patients With Locally Advanced or Metastatic Solid Tumors
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Nov 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 17, 2009Actual
Primary Completion Date
May 19, 2011Actual
Completion Date
May 17, 2012Actual
First Submitted Date
Feb 19, 2009
First Submission Date that Met QC Criteria
Feb 19, 2009
First Posted Date
Feb 20, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 14, 2019
Results First Submitted that Met QC Criteria
Nov 8, 2019
Results First Posted Date
Nov 12, 2019Actual
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
Nov 8, 2019
Last Update Posted Date
Nov 12, 2019Actual
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
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors.
The primary hypotheses are that administration of MK-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (DLT) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (MTD) in each of the 3 combinations.
Detailed Description
Not provided
Conditions Module
Conditions
Locally Advanced, Metastatic Solid Tumors
Keywords
Tumors, cancer
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
77Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-2206 + carboplatin + paclitaxel
Experimental
MK-2206 combined with carboplatin and paclitaxel
Drug: MK-2206
Drug: carboplatin
Drug: paclitaxel
MK-2206 + docetaxel
Experimental
MK-2206 combined with docetaxel plus pretreatment with a corticosteroid
Drug: MK-2206
Drug: docetaxel
Drug: corticosteroid
MK-2206 + erlotinib
Experimental
MK-2206 combined with erlotinib
Drug: MK-2206
Drug: erlotinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-2206
Drug
MK-2206 given by mouth (PO) on Days 1, 3, 5, and 7 of each 21-day cycle (30 mg, 45 mg, or 60 mg) OR MK-2206 PO on Day 1 of each 21-day cycle (60 mg, 90 mg, 135 mg, 200 mg , or 250 mg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1
A DLT was any of the following deemed drug related by investigator and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria: Grade (G)4 hematologic toxicity lasting ≥7 days; G4 thrombocytopenia; G3 or 4 febrile neutropenia and/or infection requiring treatment; G3, 4, 5 non-hematologic toxicity(with the exception of G3 nausea, vomiting, diarrhea, dehydration, or hyperglycemia that as a result of inadequate compliance with supportive care measures; alopecia, inadequately treated hypersensitivity reactions G3 elevated transaminases of ≤1 week in duration); adverse experience (AE) leading to dose reduction; unresolved toxicity causing ≥3 week delay in treatment; ≥G3 hyperglycemia; persistent increases in QTc interval; clinically significant bradycardia; and missing MK-2206 doses due to toxicity. The number of participants who experienced a DLT is presented.
Cycle 1 (Up to 21 days)
Maximum Tolerated Dose (MTD) of MK-2206 Administered Every Other Day (QOD) in Combination With Carboplatin and Paclitaxel
Participants received MK-2206 (45 or 60 mg) administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. The MTD was determined by the number of participants who experienced a dose limiting toxicity (DLT). DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Cycle 1 (Up to 21 days)
MTD of MK-2206 Administered Every Three Weeks (Q3W) in Combination With Carboplatin and Paclitaxel
Participants received MK-2206 (90, 135, or 200 mg) administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Who Had a Tumor Response of Complete Response (CR) or Partial Response (PR)
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and was recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): disappearance of all target lesions and Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions. The number of participants who had a tumor response of either CR or PR is presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria :
Participants must have locally advanced or metastatic solid tumors.
Participant is male or female greater than or equal to 18 years of age.
Participant must have a performance status less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Female participants of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication.
Participants in the MK-2206 + carboplatin/paclitaxel and MK-2206 + docetaxel treatment arms will be limited to no more than 3 prior cytotoxic therapies for metastatic or recurrent diseases.
Participant is able to swallow capsules and has no surgical or anatomical condition that will prevent the Participant from swallowing.
Exclusion Criteria:
Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks.
Participants must be least 4 weeks post-surgery and do not expect major surgery in the study duration.
Participant is currently participating or has participated in a study with an investigational compound or device within 30 days.
Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Participant with a primary central nervous system tumor.
Participant has known hypersensitivity to the components of study drug.
Participant has a history or current evidence of heart disease.
Participant has evidence of clinically significant bradycardia (slow heart rate).
Participant has uncontrolled high blood pressure.
Participant at significant risk for hypokalemia (low potassium levels).
Participant is a known diabetic
Participant has known psychiatric or substance abuse disorders.
Participant is a user of illicit drugs.
Participant is pregnant or breastfeeding.
Participant is Human Immunodeficiency Virus (HIV) positive.
Participant has known history of Hepatitis B or C or active Hepatitis A.
Participant has symptomatic ascites or pleural effusion.
Participant is receiving treatment with oral corticosteroids.
Participant is using a potent cytochrome P(450) 3A4 (CYP3A4) inhibitor or inducer.
Molife LR, Yan L, Vitfell-Rasmussen J, Zernhelt AM, Sullivan DM, Cassier PA, Chen E, Biondo A, Tetteh E, Siu LL, Patnaik A, Papadopoulos KP, de Bono JS, Tolcher AW, Minton S. Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors. J Hematol Oncol. 2014 Jan 3;7:1. doi: 10.1186/1756-8722-7-1.
77 participants were allocated to one of 3 treatment combinations with MK-2206 according to clinical presentation but 5 participants were not treated due to disease progression before initiation of treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
FG001
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
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
Jul 10, 2026
Removed Countries
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MK-2206 + carboplatin + paclitaxel
MK-2206 + docetaxel
MK-2206 + erlotinib
docetaxel
Drug
Administered as an IV infusion on Day 1 of each 21-day cycle
MK-2206 + docetaxel
Taxotere®
erlotinib
Drug
Administered daily (QD) PO in each 21-day cycle
MK-2206 + erlotinib
Tarceva®
carboplatin
Drug
Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle
MK-2206 + carboplatin + paclitaxel
Paraplatin®
paclitaxel
Drug
Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle
MK-2206 + carboplatin + paclitaxel
Taxol®
corticosteroid
Drug
Administered PO twice a day (BID) on Days 1-3 of each 21-day cycle
MK-2206 + docetaxel
Cycle 1 (up to 21 days)
MTD of MK-2206 Administered QOD in Combination With Docetaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Cycle 1 (up to 21 days)
MTD of MK-2206 Administered Q3W in Combination With Docetaxel
Participants received MK-2206 (90, 135, or 200 mg) administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Cycle 1 (up to 21 days)
MTD of MK-2206 Administered QOD in Combination With Erlotinib
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib (100 or 150 mg) administered PO once every day of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Cycle 1 (up to 21 days)
MTD of MK-2206 Administered Once Every Week (QW) in Combination With Erlotinib
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib (100 or 150 mg) administered PO once every day of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
Cycle 1 (up to 21 days)
Maximum Plasma Concentration of MK-2206 (Cmax)
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose) for the determination of MK-2206 Cmax after Dose 1. The Cmax of MK-2206 after Dose 1 will be presented.
At designated time points on Cycle 1 Day 1 (Up to 96 hours)
Time to Maximum Plasma Concentration of MK-2206 (Tmax)
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose) for the determination of MK-2206 Tmax after Dose 1. The Tmax of MK-2206 after Dose 1 will be presented.
At designated time points on Cycle 1 Day 1 (Up to 96 hours)
Minimum Plasma Concentration of MK-2206 (Ctrough)
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose) for the determination of MK-2206 Ctrough after Dose 1. The Ctrough after Dose 1 is presented and is the 48-hour postdose concentration.
At designated time points on Cycle 1 Day 1 (Up to 48 hours)
Area Under the MK-2206 Concentration Versus Time Curve From Time Zero to 48 Hours Postdose (AUC 0-48h)
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose) for the determination of MK-2206 AUC0-48h after Dose 1. The AUC0-48h after Dose 1 is presented.
At designated time points on Cycle 1 Day 1 (Up to 48 hours)
Up to approximately 4 months (6 cycles)
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
FG002
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
FG003
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
FG004
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
FG005
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
FG006
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
FG007
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
FG008
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
FG009
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
FG010
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
FG011
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
FG012
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
FG0007 subjects
FG0019 subjects
FG0026 subjects
FG0035 subjects
FG0046 subjects
FG0055 subjects
FG0063 subjects
FG0075 subjects
FG0084 subjects
FG0099 subjects
FG0104 subjects
FG0116 subjects
FG0128 subjects
Treated
FG0006 subjects1 participant was allocated but did not receive treatment due to progression of disease
FG0019 subjects
FG0025 subjects1 participant was allocated but did not receive treatment due to progression of disease
FG0035 subjects
FG0046 subjects
FG0055 subjects
FG0063 subjects
FG0074 subjects1 participant was allocated but did not receive treatment due to progression of disease
FG0084 subjects
FG0099 subjects
FG0104 subjects
FG0116 subjects
FG0126 subjects2 participants were allocated but did not receive treatment due to progression of disease
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0007 subjects
FG0019 subjects
FG0026 subjects
FG0035 subjects
FG0046 subjects
FG0055 subjects
FG0063 subjects
FG0075 subjects
FG0084 subjects
FG0099 subjects
FG0104 subjects
FG0116 subjects
FG0128 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0122 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive disease before treatment
FG0001 subjects
FG0015 subjects
FG0021 subjects
FG0033 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Progressive disease during treatment
FG0003 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
All participants who were allocated to receive treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
BG001
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
BG002
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
BG003
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
BG004
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
BG005
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
BG006
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
BG007
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
BG008
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
BG009
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
BG010
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
BG011
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
BG012
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0007
BG0019
BG0026
BG0035
BG0046
BG0055
BG0063
BG0075
BG0084
BG0099
BG0104
BG0116
BG0128
BG01377
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00051.6± 15.3
BG00158.4± 13.6
BG00256.2± 10.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0016
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1
A DLT was any of the following deemed drug related by investigator and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria: Grade (G)4 hematologic toxicity lasting ≥7 days; G4 thrombocytopenia; G3 or 4 febrile neutropenia and/or infection requiring treatment; G3, 4, 5 non-hematologic toxicity(with the exception of G3 nausea, vomiting, diarrhea, dehydration, or hyperglycemia that as a result of inadequate compliance with supportive care measures; alopecia, inadequately treated hypersensitivity reactions G3 elevated transaminases of ≤1 week in duration); adverse experience (AE) leading to dose reduction; unresolved toxicity causing ≥3 week delay in treatment; ≥G3 hyperglycemia; persistent increases in QTc interval; clinically significant bradycardia; and missing MK-2206 doses due to toxicity. The number of participants who experienced a DLT is presented.
All participants that have received one dose of study treatment
Posted
Count of Participants
Participants
Cycle 1 (Up to 21 days)
ID
Title
Description
OG000
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG001
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG002
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG003
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG004
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG005
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG006
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
Units
Counts
Participants
OG0006
OG0019
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0021
OG003
Primary
Maximum Tolerated Dose (MTD) of MK-2206 Administered Every Other Day (QOD) in Combination With Carboplatin and Paclitaxel
Participants received MK-2206 (45 or 60 mg) administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. The MTD was determined by the number of participants who experienced a dose limiting toxicity (DLT). DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
All participants who received MK-2206 QOD+carboplatin+paclitaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Posted
Number
mg
Cycle 1 (Up to 21 days)
ID
Title
Description
OG000
MK-2206 Administered QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg or 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
Primary
MTD of MK-2206 Administered Every Three Weeks (Q3W) in Combination With Carboplatin and Paclitaxel
Participants received MK-2206 (90, 135, or 200 mg) administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
All participants who received MK-2206 Q3W+carboplatin+paclitaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Posted
Number
mg
Cycle 1 (up to 21 days)
ID
Title
Description
OG000
MK-2206 Administered Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg, 135 mg, or 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
Units
Primary
MTD of MK-2206 Administered QOD in Combination With Docetaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
All participants who received MK-2206 QOD+docetaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Posted
Number
mg
Cycle 1 (up to 21 days)
ID
Title
Description
OG000
MK-2206 Administered QOD+Docetaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
Primary
MTD of MK-2206 Administered Q3W in Combination With Docetaxel
Participants received MK-2206 (90, 135, or 200 mg) administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
All participants who received MK-2206 Q3W+docetaxel and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Posted
Number
mg
Cycle 1 (up to 21 days)
ID
Title
Description
OG000
MK-2206 Administered Q3W+Docetaxel
Participants received MK-2206 90 mg, 135 mg or 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
Primary
MTD of MK-2206 Administered QOD in Combination With Erlotinib
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib (100 or 150 mg) administered PO once every day of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
All participants who received MK-2206 QOD+erlotinib and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Posted
Number
mg
Cycle 1 (up to 21 days)
ID
Title
Description
OG000
MK-2206 Administered QOD+Erlotinib
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg or 150 mg administered PO once every day of each 21-day cycle.
Units
Primary
MTD of MK-2206 Administered Once Every Week (QW) in Combination With Erlotinib
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib (100 or 150 mg) administered PO once every day of each 21-day cycle. The MTD was determined by the number of participants who experienced a DLT. DLT was defined using the NCI CTCAE version 3.0 criteria. See primary DLT outcome measure for the DLT definition. The MTD was defined as the dose level, at which the percentage of patients who experienced a DLT rate in Cycle 1 that was closest to 30%. A minimum of 13 participants were required to be enrolled per dose to calculate DLT. If the DLT threshold or enrollment quota per dose were not reached then the MTD could not be determined.
All participants who received MK-2206 QW+erlotinib and had a DLT in Cycle 1 or received 90% of the planned doses and completed all safety evaluations ≤21 days after the first administration of treatment without experiencing a DLT. MTD could not be determined according to pre-defined protocol criteria based on the enrollment number.
Posted
Number
mg
Cycle 1 (up to 21 days)
ID
Title
Description
OG000
MK-2206 Administered QW+Erlotinib
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg or 150 mg administered PO once every day of each 21-day cycle.
Units
Counts
Primary
Maximum Plasma Concentration of MK-2206 (Cmax)
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose) for the determination of MK-2206 Cmax after Dose 1. The Cmax of MK-2206 after Dose 1 will be presented.
All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed
Posted
Mean
Standard Deviation
nmol/L
At designated time points on Cycle 1 Day 1 (Up to 96 hours)
ID
Title
Description
OG000
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG001
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
Primary
Time to Maximum Plasma Concentration of MK-2206 (Tmax)
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48, 96h postdose) for the determination of MK-2206 Tmax after Dose 1. The Tmax of MK-2206 after Dose 1 will be presented.
All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed
Posted
Median
Full Range
hours
At designated time points on Cycle 1 Day 1 (Up to 96 hours)
ID
Title
Description
OG000
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG001
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
Primary
Minimum Plasma Concentration of MK-2206 (Ctrough)
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose) for the determination of MK-2206 Ctrough after Dose 1. The Ctrough after Dose 1 is presented and is the 48-hour postdose concentration.
All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed
Posted
Mean
Standard Deviation
nmol/L
At designated time points on Cycle 1 Day 1 (Up to 48 hours)
ID
Title
Description
OG000
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG001
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
Primary
Area Under the MK-2206 Concentration Versus Time Curve From Time Zero to 48 Hours Postdose (AUC 0-48h)
Blood samples are to be collected at specified time points according to arm and schedule: QOD schedule for MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48 hours(h) postdose); Q3W schedule MK-2206+carboplatin+paclitaxel and MK-2206+docetaxel (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); QOD schedule for the MK-2206+erlotinib (Cycle 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose); and QW schedule for MK-2206+erlotinib (Cycles 1 Day 1: predose and 2, 4, 6, 10, 24, 48h postdose) for the determination of MK-2206 AUC0-48h after Dose 1. The AUC0-48h after Dose 1 is presented.
All participants who received MK-2206 on Cycle 1 Day 1 and had blood samples drawn for the PK parameter being analyzed
Posted
Mean
Standard Deviation
nmol•hr/L
At designated time points on Cycle 1 Day 1 (Up to 48 hours)
ID
Title
Description
OG000
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG001
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
Secondary
Number of Participants Who Had a Tumor Response of Complete Response (CR) or Partial Response (PR)
Tumor response was assessed using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and was recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): disappearance of all target lesions and Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions. The number of participants who had a tumor response of either CR or PR is presented.
All participants who received at least one dose of study treatment and had measurable disease at baseline.
Posted
Count of Participants
Participants
Up to approximately 4 months (6 cycles)
ID
Title
Description
OG000
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG001
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG002
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Time Frame
Up to approximately 14 months (Up to 30 days after last dose of study treatment)
Description
All participants who received at least one dose of study treatment
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
MK-2206 45 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
0
6
2
6
6
6
EG001
MK-2206 60 mg QOD+Carboplatin+Paclitaxel
Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
1
9
8
9
8
9
EG002
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
0
5
3
5
5
5
EG003
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
0
5
1
5
5
5
EG004
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
0
6
2
6
5
6
EG005
MK-2206 45 mg QOD+Docetaxel 75 mg/m2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
1
5
5
5
5
5
EG006
MK-2206 90 mg Q3W+Docetaxel 60 mg/m2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
0
3
1
3
3
3
EG007
MK-2206 135 mg Q3W+Docetaxel 60 mg/m2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
0
4
3
4
3
4
EG008
MK-2206 200 mg Q3W+Docetaxel 60 mg/m2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
0
4
3
4
4
4
EG009
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
1
9
6
9
9
9
EG010
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
0
4
1
4
4
4
EG011
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
1
6
4
6
6
6
EG012
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
1
6
5
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected4 at risk
EG0080 events0 affected4 at risk
EG0092 events2 affected9 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected6 at risk
EG0121 events1 affected6 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Transaminases increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG00111 events5 affected9 at risk
EG0023 events3 affected5 at risk
EG0033 events3 affected5 at risk
EG0041 events1 affected6 at risk
EG0057 events2 affected5 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected4 at risk
EG0080 events0 affected4 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected4 at risk
EG0111 events1 affected6 at risk
EG0123 events3 affected6 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG00123 events6 affected9 at risk
EG0029 events4 affected5 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG00112 events3 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG00113 events5 affected9 at risk
EG00213 events4 affected5 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG00110 events5 affected9 at risk
EG0026 events3 affected5 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hyperacusis
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0022 events2 affected5 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Diplopia
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Eye irritation
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Orbital oedema
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Photophobia
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Vision blurred
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Visual impairment
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0011 events1 affected9 at risk
EG0023 events2 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0016 events4 affected9 at risk
EG0022 events2 affected5 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0004 events3 affected6 at risk
EG0016 events6 affected9 at risk
EG0024 events3 affected5 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Post-tussive vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Steatorrhoea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events2 affected9 at risk
EG0022 events2 affected5 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0014 events3 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Application site erythema
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Catheter site swelling
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Chest discomfort
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Chest pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Chills
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Early satiety
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 13.1
Systematic Assessment
EG0005 events4 affected6 at risk
EG0017 events6 affected9 at risk
EG0028 events4 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Malaise
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Oedema
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 13.1
Systematic Assessment
EG0004 events2 affected6 at risk
EG0013 events3 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Thirst
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Ulcer
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Candidiasis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Lung infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Paronychia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pelvic infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Viral infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Wound infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Ear abrasion
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected5 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected9 at risk
EG0022 events1 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Platelet count decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Transaminases increased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0003 events2 affected6 at risk
EG0016 events5 affected9 at risk
EG0023 events2 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0024 events1 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events3 affected9 at risk
EG0025 events3 affected5 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events4 affected9 at risk
EG0025 events2 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected9 at risk
EG0022 events2 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0004 events2 affected6 at risk
EG0013 events3 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0004 events2 affected6 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected9 at risk
EG0022 events2 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypercreatinaemia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0012 events2 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events2 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Migraine
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Multifocal motor neuropathy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events4 affected9 at risk
EG0025 events4 affected5 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Parkinsonism
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0003 events2 affected6 at risk
EG0011 events1 affected9 at risk
EG0023 events1 affected5 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Syncope
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Tonic convulsion
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Tremor
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hallucination, visual
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0023 events2 affected5 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Urogenital fistula
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0014 events4 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0014 events3 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0006 events4 affected6 at risk
EG0017 events6 affected9 at risk
EG0025 events5 affected5 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0005 events4 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0006 events4 affected6 at risk
EG0012 events2 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rash follicular
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rash morbilliform
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Angiopathy
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Flushing
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hot flush
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Raynaud's phenomenon
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected5 at risk
EG003
Enrollment in this study was discontinued with Amendment 5.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
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
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C548887
MK 2206
D000077143
Docetaxel
D000069347
Erlotinib Hydrochloride
D016190
Carboplatin
D017239
Paclitaxel
D000305
Adrenal Cortex Hormones
Ancestor Terms
ID
Term
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
D011799
Quinazolines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D056831
Coordination Complexes
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0092 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
4 subjects
FG0054 subjects
FG0062 subjects
FG0071 subjects
FG0082 subjects
FG0097 subjects
FG0103 subjects
FG0116 subjects
FG0122 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0122 subjects
63.6
± 7.8
BG00438.8± 12.4
BG00557.4± 19.7
BG00664.7± 12.0
BG00757.4± 8.0
BG00854.0± 9.4
BG00961.6± 6.1
BG01061.0± 6.4
BG01155.7± 12.7
BG01254.1± 10.9
BG01356.2± 12.4
2
BG0034
BG0041
BG0052
BG0061
BG0074
BG0083
BG0092
BG0101
BG0112
BG0124
BG01336
Male
BG0003
BG0013
BG0024
BG0031
BG0045
BG0053
BG0062
BG0071
BG0081
BG0097
BG0103
BG0114
BG0124
BG01341
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
Asian
BG0000
BG0010
BG0020
BG0030
BG0041
BG0051
BG0060
BG0070
BG0080
BG0091
BG0100
BG0110
BG0120
BG0133
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
Black or African American
BG0000
BG0011
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0132
White
BG0007
BG0018
BG0026
BG0035
BG0044
BG0054
BG0063
BG0075
BG0084
BG0098
BG0104
BG0116
BG0128
BG01372
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
OG007
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG008
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG009
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG010
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
OG011
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG012
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
5
OG0046
OG0055
OG0063
OG0074
OG0084
OG0099
OG0104
OG0116
OG0126
1
OG0042
OG0053
OG0060
OG0070
OG0081
OG0092
OG0101
OG0110
OG0121
Units
Counts
Participants
OG0009
Title
Denominators
Categories
Title
Measurements
OG000NAMTD could not be determined
Counts
Participants
OG00015
Title
Denominators
Categories
Title
Measurements
OG000NAMTD could not be determined
Units
Counts
Participants
OG0005
Title
Denominators
Categories
Title
Measurements
OG000NAMTD could not be determined
Units
Counts
Participants
OG00010
Title
Denominators
Categories
Title
Measurements
OG000NAMTD could not be determined
Counts
Participants
OG00011
Title
Denominators
Categories
Title
Measurements
OG000NAMTD could not be determined
Participants
OG0009
Title
Denominators
Categories
Title
Measurements
OG000NAMTD could not be determined
OG002
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG003
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG004
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG005
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG006
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG007
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG008
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG009
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG010
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
OG011
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG012
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
Units
Counts
Participants
OG0006
OG0018
OG0025
OG0035
OG0046
OG0055
OG0063
OG0073
OG0084
OG0099
OG0104
OG0116
OG0126
Title
Denominators
Categories
Title
Measurements
OG00057.7± 13.8
OG00188.3± 24.2
OG002144± 57.0
OG003247± 52.5
OG004431± 249
OG00542.9± 13.3
OG006106± 42.5
OG007278± 35.5
OG008287± 67.6
OG00948.8± 11.2
OG01065.6± 29.3
OG011212± 75.9
OG012244± 84.2
OG002
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG003
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG004
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG005
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG006
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG007
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG008
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG009
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG010
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
OG011
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG012
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
Units
Counts
Participants
OG0006
OG0018
OG0025
OG0035
OG0046
OG0055
OG0063
OG0073
OG0084
OG0099
OG0104
OG0116
OG0126
Title
Denominators
Categories
Title
Measurements
OG0004.0(4.0 to 6.0)
OG0018.0(6.0 to 10.0)
OG0026.0(4.0 to 10.0)
OG00310.0(6.0 to 10.0)
OG0045.0(4.0 to 10.0)
OG0056.0(4.0 to 10.0)
OG0064.0(4.0 to 10.0)
OG0076.0(4.0 to 10.0)
OG0086.0(4.0 to 6.0)
OG0096.0(4.0 to 10.0)
OG0107.0(4.0 to 24.0)
OG0116.0(2.0 to 6.0)
OG0124.0(4.0 to 10.0)
OG002
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG003
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG004
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG005
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG006
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG007
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG008
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG009
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG010
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
OG011
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG012
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
Units
Counts
Participants
OG0006
OG0018
OG0025
OG0035
OG0046
OG0055
OG0063
OG0071
OG0084
OG0099
OG0104
OG0116
OG0126
Title
Denominators
Categories
Title
Measurements
OG00024.9± 10.7
OG00140.6± 11.2
OG0021.36± 0.898
OG0034.67± 3.33
OG0042.21± 1.04
OG00517.1± 3.66
OG0062.27± 1.04
OG0073.80± NAStandard deviation could not be calculated for 1 participant
OG0083.24± 0.638
OG00923.8± 8.12
OG01036.8± 10.6
OG01196.6± 43.6
OG01295.5± 43.1
OG002
MK-2206 90 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG003
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG004
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG005
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG006
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG007
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG008
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG009
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG010
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
OG011
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG012
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
Units
Counts
Participants
OG0006
OG0018
OG0025
OG0035
OG0046
OG0055
OG0063
OG0073
OG0084
OG0099
OG0104
OG0116
OG0126
Title
Denominators
Categories
Title
Measurements
OG0001630± 496
OG0012700± 619
OG0024130± 1520
OG0037420± 1250
OG0049730± 2320
OG0051320± 395
OG0063000± 1250
OG0078090± 542
OG0087690± 1550
OG0091460± 417
OG0102110± 637
OG0116420± 2760
OG0126560± 2650
Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG003
MK-2206 135 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG004
MK-2206 200 mg Q3W+Carboplatin+Paclitaxel
Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle.
OG005
MK-2206 45 mg QOD+Docetaxel 75 mg/m^2
Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG006
MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG007
MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG008
MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2
Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily.
OG009
MK-2206 45 mg QOD+Erlotinib 100 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG010
MK-2206 45 mg QOD+Erlotinib 150 mg
Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.
OG011
MK-2206 135 mg QW+Erlotinib 100 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle.
OG012
MK-2206 135 mg QW+Erlotinib 150 mg
Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle.