A Phase Ib/II Study of LGX818 in Combination With MEK162... | NCT01543698 | Trialant
NCT01543698
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 13, 2024Actual
Enrollment
189Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumors Harboring a BRAF V600 Mutation
Interventions
LGX818
MEK162
LEE011
Countries
United States
Australia
Belgium
Canada
France
Italy
Singapore
Spain
Switzerland
Protocol Section
Identification Module
NCT ID
NCT01543698
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CMEK162X2110
Secondary IDs
ID
Type
Description
Link
C4221005
Other Identifier
Alias Study Number
2011-005875-17
EudraCT Number
Brief Title
A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors
Official Title
A Phase Ib/II, Multicenter, Open-label, Dose Escalation Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF V600 - Dependent Advanced Solid Tumors
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Feb 2024
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
May 28, 2012Actual
Primary Completion Date
Mar 9, 2023Actual
Completion Date
Mar 9, 2023Actual
First Submitted Date
Feb 1, 2012
First Submission Date that Met QC Criteria
Mar 2, 2012
First Posted Date
Mar 5, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 15, 2024
Results First Submitted that Met QC Criteria
Feb 15, 2024
Results First Posted Date
Mar 13, 2024Actual
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
Feb 15, 2024
Last Update Posted Date
Mar 13, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple combination of LGX818 and MEK162 and LEE011, followed each independently by a Phase II part to assess the clinical efficacy and to further assess the safety of the combinations in selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous schedule. Oral LEE011 will be administered once daily on a three weeks on, one week off schedule. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as 28 days. The dose escalation parts of the trial will be conducted in adult patients with BRAF V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for the dual combination and at least 12 patients for the triple combination. The dose escalation will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D declaration, patients will be enrolled in three Phase II arms for the dual combination and one Phase II arm for the triple combination. All patients will be followed for 30 days for safety assessments after study drugs discontinuation. All patients enrolled in the Phase II part of the study will be followed for survival.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors Harboring a BRAF V600 Mutation
Keywords
Advanced solid tumor,
BRAF V600 mutation
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
189Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
dual combination
Experimental
LGX818 QD and MEK162 BID
Drug: LGX818
Drug: MEK162
triple combination
Experimental
LGX818 QD and MEK162 BID and LEE011 QD 3 weeks on, 1 week off.
Drug: LGX818
Drug: MEK162
Drug: LEE011
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LGX818
Drug
dual combination
triple combination
MEK162
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs): Phase 1b
DLT was defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, as clinically relevant, as unrelated to disease, disease progression, inter-current illness, or concomitant medications, which occurred (less than equal to) <=28 days following the first dose of LGX818 and MEK162 or LGX818 and MEK162 and LEE011 (cycle 1) and met the defined criteria for the study.
Phase 1b: Cycle 1 (28 days following the first dose of LGX818 and MEK162 or LGX818 and MEK162 and LEE011)
Disease Control Rate (DCR) at Week 16: Phase 2, Arm 1 (mCRC Participants)
DCR was defined as percentage of participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD). As per Response Evaluation Criteria in Solid tumors Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis less than (<)10 millimeter [mm]). PR was defined as more than equal to (>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD).
Phase 2: Week 16
Objective Response Rate (ORR): Phase 2, Arms 2, 3 and A
ORR was defined as the percentage of participants with a best overall response of CR or PR. As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis <10 mm. PR was defined as >= 30% decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters.
Phase 2: From Day 1 of dosing till complete response or partial response achieved (maximum exposure of treatment for Phase 2 was 111.5 months]
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Overall Grades and AEs of Grade 3/4: Phase 1b
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those events with onset dates occurring during the on-treatment period (the time from the Day 1 up to 30 days after last dose). AEs were graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or confirmed diagnosis of non-resectable advanced metastatic colorectal cancer (mCRC), or any other indication upon agreement with the Sponsor, whose disease has progressed despite previous antineoplastic therapy or for whom no further effective standard therapy is available
Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation
Evidence of measurable disease as determined by RECIST v1.1
World Health Organization (WHO) Performance Status ≤ 2
Negative serum pregnancy test within 72 hours prior to the first study dose in all women of childbearing potential
Exclusion Criteria:
Progressive disease following prior treatment with RAF-inhibitors in combination with MEK-inhibitors
Symptomatic or untreated leptomeningeal disease
Symptomatic brain metastases. Patients are not permitted to receive enzyme inducing anti-epileptic drugs
Known acute or chronic pancreatitis
History or current evidence of retinal disease, retinal vein occlusion or ophthalmopathy
Clinically significant cardiac disease
Patients with abnormal laboratory values at Screening/baseline
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818/MEK162
Previous or concurrent malignancy
Pregnant or nursing (lactating) women
For addition of LEE011 in the triple combination, congenital long QT syndrome or family history of unexpected sudden cardiac death and/or hypokalemia CTCAE Grade ≥ 3, brain metastases at baseline, abnormal coagulation results PT/INR >1.5 x ULN or aPTT >1.5 x ULN.
Other protocol-defined inclusion/exclusion criteria may apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Sullivan RJ, Weber J, Patel S, Dummer R, Carlino MS, Tan DSW, Lebbe C, Siena S, Elez E, Wollenberg L, Pickard MD, Sandor V, Ascierto PA. A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K -mutant Solid Tumors. Clin Cancer Res. 2020 Oct 1;26(19):5102-5112. doi: 10.1158/1078-0432.CCR-19-3550. Epub 2020 Jul 15.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
A total of 189 participants were enrolled. Phase 1 b: 47 participants for dual combination and 21 participants for triple combination. Phase 2: a) Dual combination- Arm 1 (mCRC) =11 participants; Arm 2 (prior BRAFi melanoma) =26 participants; Arm 3 (BRAFi-naïve melanoma) =42 participants and b) Triple combination- Arm A (BRAFi-naïve melanoma) =42 participants. Dual combination of LGX818 (encorafenib) and MEK162 (binimetinib) and triple combination of LGX818, MEK162 and LEE011 (ribociclib).
Recruitment Details
This study had 2 Phases- 1b and 2. Phase 1b enrolled participants with V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600-dependent advanced solid tumors. Phase 2 enrolled participants with: BRAF V600 mutant metastatic colorectal cancer (mCRC) [Arm 1, dual]; BRAF V600 mutant melanoma who progressed after prior selective BRAF inhibitor treatment [Arm 2, dual]; metastatic BRAF mutant melanoma who were naïve to prior treatment with a selective BRAF inhibitor [Arm 3, dual]/ [Arm A, triple].
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Participants received Encorafenib 50 milligram (mg) once daily (QD) and Binimetinib 45 mg twice a daily (BID) orally 4 weeks till sponsor/investigator determined the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
Periods
Title
Milestones
Reasons Not Completed
Phase 1b
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 15, 2021
Feb 15, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug
dual combination
triple combination
LEE011
Drug
triple combination
Phase 1b: Day 1 up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months)
Number of Participants With TEAEs: Overall Grades and AEs of Grade 3/4: Phase 2
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those events with onset dates occurring during the on-treatment period (the time from the Day 1 up to 30 days after last dose). AEs were graded according to CTCAE version 4.03 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE.
Phase 2: Day 1 up to 30 days after last dose (maximum treatment exposure for Phase 2 was 111.5 months)
Area Under the Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUCinf) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
AUCinf was reported in unit of measure as hour*nanogram per millilitre (h*ng/mL).
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hours (hr) post dose on Day 1 of Cycle 1
Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1
AUClast at Steady State (AUClast,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Phase 1b: Pre dose,0.5,1.5, 2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1
Area Under the Concentration-Time Curve From Time Zero to Tau After First Dose (AUCtau) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1
AUCtau at Steady State (AUCtau,ss) of Encorafenib, Binimetinib and Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Phase 1b: Pre dose,0.5,1.5, 2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1
Cmax at Steady State (Cmax,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Phase 1b: Pre dose,0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1
Elimination Half-life (t1/2) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1
t1/2 at Steady State (t1/2,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
Phase 1b: Pre dose,0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1
Accumulation Ratio (RA) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Accumulation ratio was calculated as AUCtau,ss/AUCtau.
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 and 15 of Cycle 1
Objective Response Rate (ORR): Phase 1b
ORR was defined as the percentage of participants with a best overall response of CR or PR. As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis <10 mm. PR was defined as >= 30 % decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters.
Phase 1b: From Day 1 of dosing till complete response or partial response achieved (maximum exposure of treatment in Phase 1b was 118.3 months)
Progression Free Survival (PFS): Phase 2
PFS was defined as the time from the start of study treatment to the date of the event defined as the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate tumor assessment. Per RECIST 1.1, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis.
Phase 2: From start of study drug until documented PD or death due to any cause or censoring date (maximum exposure of treatment in Phase 2 was 111.5 months)
Time to Response (TTR): Phase 2
TTR was defined as the time from the first dose of study treatment to the first documentation of objective tumor response documented in participants with confirmed objective response (CR or PR). As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis <10 mm. PR was defined as >= 30 % decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters. Kaplan-Meier method was used for analysis.
Phase 2: From date of start of treatment until date of first documentation of objective tumor response (maximum exposure of treatment in Phase 2 was 111.5 months)
Duration of Response (DOR): Phase 2
DOR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to underlying cancer, whichever occurred first in participants with confirmed objective response (CR or PR). As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis <10 mm. PR was defined as >= 30 % decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters. Kaplan-Meier method was used for analysis.
Phase 2: From date of first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to underlying cancer, whichever occurred first (maximum exposure of treatment in Phase 2 was 111.5 months)
Overall Survival (OS): Phase 2
OS was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last contact. Analysis was performed using Kaplan-Meier method.
Phase 2: From date of start of study treatment until date of death or censoring date (maximum exposure of treatment in Phase 2 was 111.5 months)
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 1b
Molecular alterations of tumor tissues was determined using the following potential predictive markers: Biomarkers like V-raf murine sarcoma viral oncogene homolog B1 (BRAF),V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS), Phosphatase and tensin homolog (PTEN), Phosphatidylinositol 3' kinase catalytic alphapolypeptide (PIK3CA), Epidermal growth factor receptor (EGFR).
Phase 1b: Baseline
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
Molecular alterations of tumor tissues was determined using the following potential predictive markers: BRAF, HRAS, KRAS, Neuroblastoma RAS viral oncogene homolog (NRAS), PTEN, PIK3CA, Mitogen-activated protein kinase 1 (MAP2K1), Mitogen-activated protein kinase 2 (MAP2K2), EGFR.
Phase 2: Baseline
Tampa
Florida
33612
United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore
Maryland
21287
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Ophthalmic Consultants of Boston Inc (OCB)
Boston
Massachusetts
02114
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Chris O'Brien Lifehouse Hospital
Camperdown
New South Wales
02050
Australia
Melanoma Institute Australia
North Sydney
New South Wales
2060
Australia
Westmead Hospital-Redbank Rd
Northmead
New South Wales
2152
Australia
Westmead Hospital-Redbank Rd
Westmead
New South Wales
2145
Australia
Westmead Hospital
Westmead
New South Wales
2145
Australia
Melanoma Institute Australia
North Sydney
2065
Australia
UZ Leuven- Gasthuisberg Campus
Leuven
Vlaams Brabant
3000
Belgium
Sir Mortimer B. Davis-Jewish General Hospital
Montreal
Quebec
H3T 1E2
Canada
Hôpital Saint louis
Paris
75010
France
Service de radiologie - Hopital Saint Louis
Paris
75475
France
Azienda Ospedaliera Monaldi
Naples
Campania
80131
Italy
Azienda Ospedaliera Universitaria Federico II
Naples
Campania
80131
Italy
IRCCS Fondazione Pascale
Naples
Campania
80131
Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan
20162
Italy
Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale
Naples
80131
Italy
National Cancer Centre Singapore
Singapore
169610
Singapore
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona
08035
Spain
Hospital Universitario HM Sanchinarro ? CIOCC
Madrid
28050
Spain
University Hospital Zürich, Dermatology
Zurich-Airport
Canton of Zurich
8058
Switzerland
Kantonsspital St. Gallen
Sankt Gallen
9007
Switzerland
FG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG002
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG003
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG004
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG005
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG006
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally for 4 weeks till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 100 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 200 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 400 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg BID orally for 3 weeks on, 1 week off schedule, till sponsor/investigator determined MTD and/or RP2D, until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG011
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG012
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG013
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG014
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
FG0006 subjectsPhase 1b participants received dual combination therapy.
FG0015 subjectsPhase 1b participants received dual combination therapy.
FG0024 subjectsPhase 1b participants received dual combination therapy.
FG0035 subjectsPhase 1b participants received dual combination therapy.
FG00413 subjectsPhase 1b participants received dual combination therapy.
FG0058 subjectsPhase 1b participants received dual combination therapy.
FG0066 subjectsPhase 1b participants received dual combination therapy.
FG0074 subjectsPhase 1b participants received triple combination therapy.
FG0085 subjectsPhase 1b participants received triple combination therapy.
FG0096 subjectsPhase 1b participants received triple combination therapy.
FG0106 subjectsPhase 1b participants received triple combination therapy.
FG0110 subjectsNo participants in this arm enrolled in Phase 1b.
FG0120 subjectsNo participants in this arm enrolled in Phase 1b.
FG0130 subjectsNo participants in this arm enrolled in Phase 1b.
FG0140 subjectsNo participants in this arm enrolled in Phase 1b.
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
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG0006 subjects
FG0015 subjects
FG0024 subjects
FG0035 subjects
FG00413 subjects
FG0058 subjects
FG0066 subjects
FG0074 subjects
FG0085 subjects
FG0096 subjects
FG0106 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Disease progression
FG0002 subjects
FG0014 subjects
FG0023 subjects
FG0032 subjects
FG00410 subjects
FG0056 subjects
FG0065 subjects
FG0073 subjects
FG0084 subjects
FG0095 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Administrative problems
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase 2
Type
Comment
Milestone Data
STARTED
FG0000 subjectsNo participants in this arm enrolled in Phase 2.
FG0010 subjectsNo participants in this arm enrolled in Phase 2.
FG0020 subjectsNo participants in this arm enrolled in Phase 2.
FG0030 subjectsNo participants in this arm enrolled in Phase 2.
FG0040 subjectsNo participants in this arm enrolled in Phase 2.
FG0050 subjectsNo participants in this arm enrolled in Phase 2.
FG0060 subjectsNo participants in this arm enrolled in Phase 2.
FG0070 subjectsNo participants in this arm enrolled in Phase 2.
FG0080 subjectsNo participants in this arm enrolled in Phase 2.
FG0090 subjectsNo participants in this arm enrolled in Phase 2.
FG0100 subjectsNo participants in this arm enrolled in Phase 2.
FG01111 subjectsPhase 2 participants received dual combination therapy.
FG01226 subjectsPhase 2 participants received dual combination therapy.
FG01342 subjectsPhase 2 participants received dual combination therapy.
FG01442 subjectsPhase 2 participants received triple combination therapy.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety set included all participants who received at least one dose of Encorafenib or Binimetinib or Ribociclib and had at least one valid post-baseline safety assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
BG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
BG002
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
BG003
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
BG004
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
BG005
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
BG006
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on, 1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on, 1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on, 1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
BG011
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
BG012
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
BG013
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
BG014
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0015
BG0024
BG0035
BG00413
BG0058
BG0066
BG0074
BG0085
BG0096
BG0106
BG01111
BG01226
BG01342
BG01442
BG015189
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
Caucasian
BG0004
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Ethnicity
Title
Measurements
Hispanic/Latino
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 With Dose Limiting Toxicities (DLTs): Phase 1b
DLT was defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, as clinically relevant, as unrelated to disease, disease progression, inter-current illness, or concomitant medications, which occurred (less than equal to) <=28 days following the first dose of LGX818 and MEK162 or LGX818 and MEK162 and LEE011 (cycle 1) and met the defined criteria for the study.
Dose Determining Set (DDS) included all Phase 1b participants from the safety set who either completed a minimum exposure requirement and had sufficient safety evaluations or discontinued prematurely due to a DLT. All participants reported under "Number of Participants Analyzed" contributed data to this outcome measure.
Posted
Count of Participants
Participants
Phase 1b: Cycle 1 (28 days following the first dose of LGX818 and MEK162 or LGX818 and MEK162 and LEE011)
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Disease Control Rate (DCR) at Week 16: Phase 2, Arm 1 (mCRC Participants)
DCR was defined as percentage of participants with a best overall response of complete response (CR), partial response (PR) or stable disease (SD). As per Response Evaluation Criteria in Solid tumors Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis less than (<)10 millimeter [mm]). PR was defined as more than equal to (>=) 30 percent (%) decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD).
Full Analysis Set (FAS) included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
Posted
Number
95% Confidence Interval
Percentage of participants
Phase 2: Week 16
ID
Title
Description
OG000
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
Units
Counts
Primary
Objective Response Rate (ORR): Phase 2, Arms 2, 3 and A
ORR was defined as the percentage of participants with a best overall response of CR or PR. As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis <10 mm. PR was defined as >= 30% decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters.
FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
Posted
Number
95% Confidence Interval
Percentage of participants
Phase 2: From Day 1 of dosing till complete response or partial response achieved (maximum exposure of treatment for Phase 2 was 111.5 months]
ID
Title
Description
OG000
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG001
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG002
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Overall Grades and AEs of Grade 3/4: Phase 1b
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those events with onset dates occurring during the on-treatment period (the time from the Day 1 up to 30 days after last dose). AEs were graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE.
Safety set included all participants who received at least one dose of LGX818 or MEK162 or LEE011 and had at least one valid post-baseline safety assessment.
Posted
Count of Participants
Participants
Phase 1b: Day 1 up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months)
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Secondary
Number of Participants With TEAEs: Overall Grades and AEs of Grade 3/4: Phase 2
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those events with onset dates occurring during the on-treatment period (the time from the Day 1 up to 30 days after last dose). AEs were graded according to CTCAE version 4.03 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE.
Safety set included all participants who received at least one dose of LGX818 or MEK162 or LEE011 and had at least one valid post-baseline safety assessment.
Posted
Count of Participants
Participants
Phase 2: Day 1 up to 30 days after last dose (maximum treatment exposure for Phase 2 was 111.5 months)
ID
Title
Description
OG000
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
OG001
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
Secondary
Area Under the Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUCinf) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
AUCinf was reported in unit of measure as hour*nanogram per millilitre (h*ng/mL).
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
h*ng/mL
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hours (hr) post dose on Day 1 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Secondary
Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
h*ng/mL
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Secondary
AUClast at Steady State (AUClast,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
h*ng/mL
Phase 1b: Pre dose,0.5,1.5, 2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Secondary
Area Under the Concentration-Time Curve From Time Zero to Tau After First Dose (AUCtau) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
h*ng/mL
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Secondary
AUCtau at Steady State (AUCtau,ss) of Encorafenib, Binimetinib and Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
h*ng/mL
Phase 1b: Pre dose,0.5,1.5, 2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Secondary
Maximum Observed Plasma Concentration (Cmax) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
ng/mL
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Secondary
Cmax at Steady State (Cmax,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
ng/mL
Phase 1b: Pre dose,0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg + Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Secondary
Elimination Half-life (t1/2) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
Hour
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Secondary
t1/2 at Steady State (t1/2,ss) of Encorafenib, Binimetinib, Ribociclib, Metabolite of Binimetinib and Ribociclib: Phase 1b
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
Hour
Phase 1b: Pre dose,0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 15 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Secondary
Accumulation Ratio (RA) of Encorafenib, Binimetinib, Ribociclib Metabolite of Binimetinib and Ribociclib: Phase 1b
Accumulation ratio was calculated as AUCtau,ss/AUCtau.
FAS evaluated. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.
Posted
Mean
Standard Deviation
Ratio
Phase 1b: Pre dose, 0.5,1.5,2.5,4,6,8 and 24 hr post dose on Day 1 and 15 of Cycle 1
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Secondary
Objective Response Rate (ORR): Phase 1b
ORR was defined as the percentage of participants with a best overall response of CR or PR. As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis <10 mm. PR was defined as >= 30 % decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters.
FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
Posted
Number
95% Confidence Interval
Percentage of participants
Phase 1b: From Day 1 of dosing till complete response or partial response achieved (maximum exposure of treatment in Phase 1b was 118.3 months)
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Secondary
Progression Free Survival (PFS): Phase 2
PFS was defined as the time from the start of study treatment to the date of the event defined as the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate tumor assessment. Per RECIST 1.1, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis.
FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
Posted
Median
95% Confidence Interval
Months
Phase 2: From start of study drug until documented PD or death due to any cause or censoring date (maximum exposure of treatment in Phase 2 was 111.5 months)
ID
Title
Description
OG000
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
OG001
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
Secondary
Time to Response (TTR): Phase 2
TTR was defined as the time from the first dose of study treatment to the first documentation of objective tumor response documented in participants with confirmed objective response (CR or PR). As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis <10 mm. PR was defined as >= 30 % decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters. Kaplan-Meier method was used for analysis.
FAS evaluated.Here "Number of Participants Analyzed" signifies the number of participants who were confirmed responders and were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
Phase 2: From date of start of treatment until date of first documentation of objective tumor response (maximum exposure of treatment in Phase 2 was 111.5 months)
ID
Title
Description
OG000
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
OG001
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
Secondary
Duration of Response (DOR): Phase 2
DOR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to underlying cancer, whichever occurred first in participants with confirmed objective response (CR or PR). As per RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must have a reduction in short axis <10 mm. PR was defined as >= 30 % decrease under baseline of sum of diameters of all target lesions taking as reference the baseline sum of diameters. Kaplan-Meier method was used for analysis.
FAS evaluated.Here "Number of Participants Analyzed" signifies the number of participants who were confirmed responders and were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
Phase 2: From date of first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to underlying cancer, whichever occurred first (maximum exposure of treatment in Phase 2 was 111.5 months)
ID
Title
Description
OG000
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
OG001
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Secondary
Overall Survival (OS): Phase 2
OS was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a participant was not known to have died, survival was censored at the date of last contact. Analysis was performed using Kaplan-Meier method.
FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
Posted
Median
95% Confidence Interval
Months
Phase 2: From date of start of study treatment until date of death or censoring date (maximum exposure of treatment in Phase 2 was 111.5 months)
ID
Title
Description
OG000
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
OG001
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG002
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Secondary
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 1b
Molecular alterations of tumor tissues was determined using the following potential predictive markers: Biomarkers like V-raf murine sarcoma viral oncogene homolog B1 (BRAF),V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS), Phosphatase and tensin homolog (PTEN), Phosphatidylinositol 3' kinase catalytic alphapolypeptide (PIK3CA), Epidermal growth factor receptor (EGFR).
FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
Posted
Count of Participants
Participants
Phase 1b: Baseline
ID
Title
Description
OG000
Phase 1b: Encorafenib 50 mg+ Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG002
Phase 1b: Encorafenib 200 mg+ Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Secondary
Number of Participants With Molecular Alterations of Tumor Tissues Using Potential Predictive Markers: Phase 2
Molecular alterations of tumor tissues was determined using the following potential predictive markers: BRAF, HRAS, KRAS, Neuroblastoma RAS viral oncogene homolog (NRAS), PTEN, PIK3CA, Mitogen-activated protein kinase 1 (MAP2K1), Mitogen-activated protein kinase 2 (MAP2K2), EGFR.
FAS included all participants who received at least one dose of LGX818 or MEK162 or LEE011.
Posted
Count of Participants
Participants
Phase 2: Baseline
ID
Title
Description
OG000
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
OG001
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG002
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Time Frame
Day 1 of dosing up to 30 days after last dose (maximum treatment exposure for Phase 1b was 118.3 months, Phase 2 was 111.5 months)
Description
Same event may appear as both non-SAE and SAE, but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set was evaluated.
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
Phase 1b: Encorafenib 50 mg + Binimetinib 45 mg
Participants received Encorafenib 50 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
1
6
4
6
6
6
EG001
Phase 1b: Encorafenib 100 mg+ Binimetinib 45 mg
Participants received Encorafenib 100 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
0
5
2
5
5
5
EG002
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
1
4
2
4
4
4
EG003
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
2
5
2
5
5
5
EG004
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
2
13
5
13
13
13
EG005
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
0
8
4
8
8
8
EG006
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on, 1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on, 1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on, 1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
2
6
2
6
6
6
EG011
Phase 2: Arm 1 (mCRC): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks until disease progression, unacceptable toxicity or withdrawal of informed consent, whichever occurred first.
9
11
5
11
11
11
EG012
Phase 2: Arm 2 (Prior BRAFi Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
22
26
13
26
26
26
EG013
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
22
42
18
42
39
42
EG014
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
28
42
21
42
42
42
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Intracardiac mass
Cardiac disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG0030 affected5 at risk
EG0040 affected13 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
Tachycardia
Cardiac disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Retinal detachment
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Retinopathy hypertensive
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pharyngeal abscess
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Septic shock
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Skin infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pubis fracture
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Bone disorder
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Nerve root compression
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Seizure
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Blindness
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Iritis
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Visual impairment
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Detachment of retinal pigment epithelium
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Macular oedema
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Axillary pain
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Chills
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
General physical health deterioration
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Disease progression
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Erysipelas
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Lung infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Dermo-hypodermitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Intracranial tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Ataxia
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Tremor
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Lymphadenectomy
Surgical and medical procedures
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Troponin increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hypercreatininaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Mediastinoscopy
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0021 affected4 at risk
EG0031 affected5 at risk
EG0041 affected13 at risk
EG0053 affected8 at risk
EG0060 affected6 at risk
EG0071 affected4 at risk
EG0081 affected5 at risk
EG0092 affected6 at risk
EG0102 affected6 at risk
EG0111 affected11 at risk
EG0126 affected26 at risk
EG0137 affected42 at risk
EG01411 affected42 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Detachment of retinal pigment epithelium
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Macular oedema
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Retinal detachment
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Chorioretinopathy
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Photophobia
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Retinopathy
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Subretinal fluid
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0011 affected5 at risk
EG0021 affected4 at risk
EG003
Visual impairment
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Cataract
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0012 affected5 at risk
EG0020 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0013 affected5 at risk
EG0022 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0004 affected6 at risk
EG0011 affected5 at risk
EG0021 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0012 affected5 at risk
EG0020 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected5 at risk
EG0021 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0014 affected5 at risk
EG0022 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected5 at risk
EG0024 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Retinal degeneration
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected5 at risk
EG0020 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Asthenia
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0004 affected6 at risk
EG0012 affected5 at risk
EG0020 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Chills
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0004 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Peripheral swelling
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0021 affected4 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0012 affected5 at risk
EG0021 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0012 affected5 at risk
EG0020 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0012 affected5 at risk
EG0020 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Weight increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hypercreatininaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0013 affected5 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected5 at risk
EG0021 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected5 at risk
EG0022 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected5 at risk
EG0021 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Migraine
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0004 affected6 at risk
EG0013 affected5 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected5 at risk
EG0020 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected5 at risk
EG0022 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0021 affected4 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0021 affected4 at risk
EG003
Hair texture abnormal
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Flushing
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hot flush
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected5 at risk
EG0020 affected4 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Uveitis
Eye disorders
MedDRA v18.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Chest pain
General disorders
MedDRA v18.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0010 affected5 at risk
EG0020 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
Units
Counts
Participants
OG00026
OG00142
OG00242
Title
Denominators
Categories
Title
Measurements
OG00042.3(23.4 to 63.1)
OG00166.7(50.5 to 80.4)
OG00259.5(43.3 to 74.4)
OG002
Phase 1b: Encorafenib 200 mg + Binimetinib 45 mg
Participants received Encorafenib 200 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG003
Phase 1b: Encorafenib 400 mg + Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Overall Grades
Title
Measurements
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Grade 3/4
Title
Measurements
OG0005
OG0012
OG0022
OG003
OG002
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG003
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
Units
Counts
Participants
OG00011
OG00126
OG00242
OG00342
Title
Denominators
Categories
Overall Grades
Title
Measurements
OG00011
OG00126
OG00242
OG00342
Grade 3/4
Title
Measurements
OG0005
OG00115
OG00227
OG003
OG003
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00413
ParticipantsOG0057
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG0105
Title
Measurements
OG0003740± 2350
OG00111700± 6200
OG00222000± 9790
OG003
Binimetinib
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0033
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg+ Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00413
ParticipantsOG0057
ParticipantsOG0066
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG0003690± 2340
OG00111500± 6070
OG00222000± 9750
OG003
Binimetinib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg+ Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG00411
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG0002620± 1260
OG0015510± 1280
OG0024620± 1640
OG003
Binimetinib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0034
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0034
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg+ Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00413
ParticipantsOG0057
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG0105
Title
Measurements
OG0003700± 2320
OG00111500± 6070
OG00222000± 9750
OG003
Binimetinib
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0033
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg+ Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG00411
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG0002620± 1260
OG0015510± 1280
OG0024620± 1640
OG003
Binimetinib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0034
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0032
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg+ Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg + Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00413
ParticipantsOG0057
ParticipantsOG0066
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG000855± 480
OG0011930± 652
OG0023820± 1550
OG003
Binimetinib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0034
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg+ Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG00411
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG000587± 321
OG0011190± 409
OG0021060± 194
OG003
Binimetinib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0034
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0034
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG00413
ParticipantsOG0057
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG0105
Title
Measurements
OG0003.68± 0.605
OG0013.65± 0.351
OG0022.88± 0.121
OG003
Binimetinib
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG0033
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0005
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg + Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG00411
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0104
Title
Measurements
OG0004.74± 1.18
OG0014.47± 0.380
OG0024.32± 1.25
OG003
Binimetinib
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0034
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg + Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg+ Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Encorafenib
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG00411
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG0104
Title
Measurements
OG0000.857± 0.351
OG0010.601± 0.322
OG0020.298± 0.0682
OG003
Binimetinib
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0034
Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Metabolite of Binimetinib
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0032
Metabolite of Ribociclib
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg+ Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
Title
Measurements
OG00066.7(22.3 to 95.7)
OG00140.0(5.3 to 85.3)
OG00225.0(0.6 to 80.6)
OG00340.0(5.3 to 85.3)
OG00453.8(25.1 to 80.8)
OG00525.0(3.2 to 65.1)
OG00650.0(11.8 to 88.2)
OG00775.0(19.4 to 99.4)
OG00860.0(14.7 to 94.7)
OG00966.7(22.3 to 95.7)
OG01066.7(22.3 to 95.7)
OG002
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG003
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
Units
Counts
Participants
OG00011
OG00126
OG00242
OG00342
Title
Denominators
Categories
Title
Measurements
OG0005.4(2.1 to 9.0)
OG0013.8(3.4 to 9.3)
OG0027.5(5.7 to 12.2)
OG0039.0(5.6 to 11.1)
OG002
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG003
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
Units
Counts
Participants
OG0002
OG00111
OG00228
OG00325
Title
Denominators
Categories
Title
Measurements
OG0002.6(1.6 to 3.6)
OG0011.8(1.0 to 5.6)
OG0021.0(1.0 to 1.8)
OG0031.9(1.8 to 2.1)
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG002
Phase 2: Arm 3 (BRAFi-naïve Melanoma): Encorafenib + Binimetinib
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG003
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
Units
Counts
Participants
OG0002
OG00111
OG00228
OG00325
Title
Denominators
Categories
Title
Measurements
OG0007.1(3.8 to NA)Upper limit of CI could not be estimated because of insufficient number of participants with this event and hence could not be reported.
OG0013.8(2.9 to 12.9)
OG00210.9(6.5 to 19.5)
OG0037.5(5.6 to 25.8)
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG003
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
Units
Counts
Participants
OG00011
OG00126
OG00242
OG00342
Title
Denominators
Categories
Title
Measurements
OG0009.5(7.7 to 27.2)
OG00111.4(5.9 to 20.7)
OG00223.1(17.3 to NA)Upper limit of CI could not be estimated because of insufficient number of participants with this event and hence could not be reported.
OG00321.8(14.8 to 35.7)
OG003
Phase 1b: Encorafenib 400 mg+ Binimetinib 45 mg
Participants received Encorafenib 400 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG004
Phase 1b: Encorafenib 450 mg+ Binimetinib 45 mg
Participants received Encorafenib 450 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG005
Phase 1b: Encorafenib 600 mg+ Binimetinib 45 mg
Participants received Encorafenib 600 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
OG006
Phase 1b: Encorafenib 800 mg+ Binimetinib 45 mg
Participants received Encorafenib 800 mg QD and Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 100 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 200 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 400 mg QD orally for 3 weeks on,1 week off schedule.
Participants received Encorafenib 200 mg QD, Binimetinib 45 mg BID orally on a schedule of continuous 4 weeks and Ribociclib 600 mg QD orally for 3 weeks on,1 week off schedule.
Units
Counts
Participants
OG0006
OG0015
OG0024
OG0035
OG00413
OG0058
OG0066
OG0074
OG0085
OG0096
OG0106
Title
Denominators
Categories
BRAF
Title
Measurements
OG0005
OG0014
OG0023
OG0034
OG0047
OG0057
OG0063
OG0073
OG0084
OG0095
OG0104
KRAS
Title
Measurements
OG0001
OG0010
OG0020
OG003
PTEN
Title
Measurements
OG0000
OG0011
OG0020
OG003
PIK3CA
Title
Measurements
OG0000
OG0011
OG0020
OG003
EGFR
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received Encorafenib at MTD (600 mg QD, permitted dose reduction to 450 mg QD) and Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks.
OG003
Phase 2: Arm A (BRAFi-naïve Melanoma): Encorafenib + Binimetinib + Ribociclib
Participants received Encorafenib 200 mg QD (MTD), Binimetinib 45 mg BID orally on a continuous schedule of 4 weeks, and Ribociclib 600 mg QD orally for 3 weeks on, 1 week off schedule.
Units
Counts
Participants
OG00011
OG00126
OG00242
OG00342
Title
Denominators
Categories
BRAF
Title
Measurements
OG0004
OG00115
OG00220
OG00330
HRAS
Title
Measurements
OG0000
OG0010
OG0020
OG003
KRAS
Title
Measurements
OG0002
OG0010
OG0020
OG003
NRAS
Title
Measurements
OG0000
OG0012
OG0020
OG003
PTEN
Title
Measurements
OG0001
OG0016
OG0025
OG003
PIK3CA
Title
Measurements
OG0002
OG0010
OG0020
OG003
MAP2K1
Title
Measurements
OG0000
OG0013
OG0021
OG003
MAP2K2
Title
Measurements
OG0000
OG0010
OG0020
OG003
ARAF
Title
Measurements
OG0000
OG0010
OG0020
OG003
EGFR
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0121 affected26 at risk
EG0131 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0141 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0081 affected5 at risk
EG0091 affected6 at risk
EG0101 affected6 at risk
EG0112 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
1 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0123 affected26 at risk
EG0132 affected42 at risk
EG0142 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
1 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0111 affected11 at risk
EG0123 affected26 at risk
EG0132 affected42 at risk
EG0143 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0081 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0122 affected26 at risk
EG0133 affected42 at risk
EG0142 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0111 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0121 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0131 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0131 affected42 at risk
EG0140 affected42 at risk
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EG0111 affected11 at risk
EG0125 affected26 at risk
EG0135 affected42 at risk
EG0148 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0122 affected26 at risk
EG0132 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0062 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0052 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0051 affected8 at risk
EG0062 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0042 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
1 affected
5 at risk
EG0042 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0101 affected6 at risk
EG0111 affected11 at risk
EG0121 affected26 at risk
EG0132 affected42 at risk
EG0146 affected42 at risk
2 affected
5 at risk
EG0043 affected13 at risk
EG0052 affected8 at risk
EG0065 affected6 at risk
EG0071 affected4 at risk
EG0081 affected5 at risk
EG0090 affected6 at risk
EG0102 affected6 at risk
EG0111 affected11 at risk
EG0121 affected26 at risk
EG0138 affected42 at risk
EG01410 affected42 at risk
0 affected
5 at risk
EG0042 affected13 at risk
EG0052 affected8 at risk
EG0062 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0112 affected11 at risk
EG0121 affected26 at risk
EG0139 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0051 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0135 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0111 affected11 at risk
EG0121 affected26 at risk
EG0133 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0062 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0052 affected8 at risk
EG0062 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0051 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
1 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0121 affected26 at risk
EG0133 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0044 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0111 affected11 at risk
EG0121 affected26 at risk
EG0134 affected42 at risk
EG0140 affected42 at risk
2 affected
5 at risk
EG0042 affected13 at risk
EG0051 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0081 affected5 at risk
EG0090 affected6 at risk
EG0101 affected6 at risk
EG0113 affected11 at risk
EG0126 affected26 at risk
EG01311 affected42 at risk
EG0143 affected42 at risk
1 affected
5 at risk
EG0041 affected13 at risk
EG0053 affected8 at risk
EG0061 affected6 at risk
EG0071 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0101 affected6 at risk
EG0110 affected11 at risk
EG0121 affected26 at risk
EG0137 affected42 at risk
EG0145 affected42 at risk
0 affected
5 at risk
EG0042 affected13 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0112 affected11 at risk
EG0120 affected26 at risk
EG0132 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0113 affected11 at risk
EG0122 affected26 at risk
EG0131 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0121 affected26 at risk
EG0133 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0042 affected13 at risk
EG0051 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
1 affected
5 at risk
EG0040 affected13 at risk
EG0051 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0051 affected8 at risk
EG0062 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0112 affected11 at risk
EG0120 affected26 at risk
EG0133 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0043 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0062 affected6 at risk
EG0070 affected4 at risk
EG0081 affected5 at risk
EG0091 affected6 at risk
EG0102 affected6 at risk
EG0111 affected11 at risk
EG0121 affected26 at risk
EG0138 affected42 at risk
EG0143 affected42 at risk
1 affected
5 at risk
EG0042 affected13 at risk
EG0050 affected8 at risk
EG0063 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0102 affected6 at risk
EG0111 affected11 at risk
EG0124 affected26 at risk
EG01311 affected42 at risk
EG0145 affected42 at risk
0 affected
5 at risk
EG0042 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0111 affected11 at risk
EG0123 affected26 at risk
EG0135 affected42 at risk
EG0145 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0051 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0081 affected5 at risk
EG0091 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0144 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0081 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0143 affected42 at risk
0 affected
5 at risk
EG0042 affected13 at risk
EG0051 affected8 at risk
EG0062 affected6 at risk
EG0070 affected4 at risk
EG0081 affected5 at risk
EG0090 affected6 at risk
EG0102 affected6 at risk
EG0110 affected11 at risk
EG0123 affected26 at risk
EG01312 affected42 at risk
EG0144 affected42 at risk
0 affected
5 at risk
EG0043 affected13 at risk
EG0051 affected8 at risk
EG0062 affected6 at risk
EG0072 affected4 at risk
EG0081 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0129 affected26 at risk
EG0138 affected42 at risk
EG0147 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0121 affected26 at risk
EG0133 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0111 affected11 at risk
EG0122 affected26 at risk
EG0134 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0042 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0043 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0043 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0043 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0051 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0043 affected13 at risk
EG0051 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0111 affected11 at risk
EG0121 affected26 at risk
EG0139 affected42 at risk
EG0149 affected42 at risk
1 affected
5 at risk
EG0041 affected13 at risk
EG0052 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0051 affected8 at risk
EG0062 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
1 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0121 affected26 at risk
EG0133 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0121 affected26 at risk
EG0133 affected42 at risk
EG0140 affected42 at risk
1 affected
5 at risk
EG0041 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0042 affected13 at risk
EG0051 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0140 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0060 affected6 at risk
EG0070 affected4 at risk
EG0081 affected5 at risk
EG0091 affected6 at risk
EG0100 affected6 at risk
EG0110 affected11 at risk
EG0120 affected26 at risk
EG0130 affected42 at risk
EG0144 affected42 at risk
0 affected
5 at risk
EG0040 affected13 at risk
EG0050 affected8 at risk
EG0061 affected6 at risk
EG0070 affected4 at risk
EG0080 affected5 at risk
EG0090 affected6 at risk
EG0100 affected6 at risk
EG0111 affected11 at risk
EG0120 affected26 at risk
EG0134 affected42 at risk
EG0140 affected42 at risk
4
OG0048
OG0056
OG0066
OG0074
OG0084
OG0096
OG0106
34
42000
± 23600
OG00436700± 19400
OG00557400± 27100
OG00640200± 12100
OG00715000± 7360
OG0089960± 5940
OG00918900± 9900
OG01017400± 9480
Participants
OG004
11
ParticipantsOG0057
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG0104
Title
Measurements
OG0002190± 1350
OG0011930± 529
OG0023730± 2250
OG0031960± 1140
OG0042750± 1490
OG0053090± 1600
OG0062340± 462
OG0072160± 1580
OG0083000± 932
OG0093110± 1450
OG0102970± 458
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0094
ParticipantsOG0104
Title
Measurements
OG0071040± 665
OG0083030± 1600
OG0097930± 5180
OG01018200± 10400
ParticipantsOG0049
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0090
ParticipantsOG0104
Title
Measurements
OG000321± 225
OG001271± 28.9
OG002631± 296
OG003275± 121
OG004361± 184
OG005449± 302
OG006361± 78.1
OG007173± 55.6
OG008337± 29.2
OG010239± 79.1
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0083
ParticipantsOG0091
ParticipantsOG0101
Title
Measurements
OG007194± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG008601± 225
OG0091340± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG0102160± NAStandard deviation could not be calculated as only 1 participant was evaluable.
40200
± 21700
OG00436100± 19300
OG00557000± 26800
OG00638100± 11800
OG00711400± 4530
OG0089280± 4190
OG00912700± 5020
OG01015800± 7160
Participants
OG004
13
ParticipantsOG0057
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG0001990± 1130
OG0011990± 715
OG0023300± 1990
OG0031870± 867
OG0042330± 1220
OG0052790± 1480
OG0062120± 478
OG0071520± 663
OG0082470± 878
OG0092020± 843
OG0102320± 635
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG007806± 549
OG0082550± 1280
OG0096700± 3720
OG01014500± 7490
ParticipantsOG00413
ParticipantsOG0057
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG000276± 184
OG001280± 50.5
OG002372± 320
OG003241± 82.5
OG004287± 122
OG005340± 244
OG006307± 78.4
OG007156± 53.8
OG008259± 54.3
OG009168± 109
OG010161± 81.9
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG00781.4± 41.0
OG008397± 145
OG009758± 231
OG0101200± 320
10200
± 2280
OG00415900± 8730
OG00527300± 17900
OG00625300± 7240
OG0076310± 2340
OG0088210± 2550
OG00911800± 7000
OG01015700± 6060
Participants
OG004
11
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG0002950± 1380
OG0012610± 873
OG0022660± 1900
OG0032110± 1220
OG0042550± 901
OG0052590± 1640
OG0062540± 529
OG0072180± 1180
OG0082820± 954
OG0092740± 1230
OG0102970± 1180
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG007462± 129
OG0081520± 979
OG0095620± 3730
OG01010100± 2970
ParticipantsOG00411
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG000147± 152
OG001173± 125
OG002118± 70.7
OG003119± 96.5
OG004157± 104
OG005132± 142
OG006190± 79.8
OG007149± 136
OG008210± 68.4
OG009176± 92.5
OG010169± 48.5
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG007255± 131
OG008729± 267
OG0092150± 399
OG0103260± 891
40200
± 21700
OG00436300± 19000
OG00557000± 26800
OG00640000± 12100
OG00714800± 7140
OG0089940± 5900
OG00918700± 9730
OG01017300± 9300
Participants
OG004
11
ParticipantsOG0057
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG0104
Title
Measurements
OG0002130± 1330
OG0011860± 532
OG0023600± 2160
OG0031890± 1110
OG0042650± 1410
OG0053010± 1560
OG0062280± 477
OG0071790± 979
OG0082900± 939
OG0092860± 1320
OG0102900± 453
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG007845± 504
OG0082550± 1280
OG0096700± 3720
OG01014500± 7490
ParticipantsOG0049
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0090
ParticipantsOG0104
Title
Measurements
OG000307± 222
OG001265± 27.9
OG002585± 304
OG003257± 109
OG004338± 162
OG005430± 291
OG006344± 82.0
OG007152± 32.3
OG008322± 23.5
OG010230± 79.1
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG00798.9± 25.9
OG008397± 145
OG009758± 231
OG0101200± 320
10200
± 2280
OG00415900± 8730
OG00527300± 17900
OG00625300± 7240
OG0076310± 2340
OG0088210± 2550
OG00911800± 7000
OG01015700± 6060
Participants
OG004
11
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG0002950± 1380
OG0012610± 873
OG0022660± 1900
OG0032110± 1220
OG0042550± 901
OG0052590± 1640
OG0062540± 529
OG0072180± 1180
OG0082820± 954
OG0092740± 1230
OG0102970± 1180
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG007462± 129
OG0081520± 979
OG0095620± 3730
OG01010100± 2970
ParticipantsOG0047
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0072
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0105
Title
Measurements
OG000261± 136
OG001237± 107
OG002126± 59.5
OG003194± 75.8
OG004221± 83.5
OG005304± 77.7
OG006225± 25.1
OG007265± 33.4
OG008219± 71.5
OG009207± 69.7
OG010175± 52.8
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG007255± 131
OG008729± 267
OG0092150± 399
OG0103260± 891
6930
± 1950
OG0047620± 3350
OG00510300± 3170
OG0067880± 2910
OG0072920± 499
OG0083190± 1010
OG0093450± 1140
OG0104200± 1020
Participants
OG004
13
ParticipantsOG0057
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG000635± 402
OG001587± 147
OG002986± 771
OG003532± 227
OG004807± 398
OG005901± 480
OG006621± 160
OG007462± 85.6
OG008867± 232
OG009560± 213
OG010703± 222
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG00774.2± 37.5
OG008219± 95.2
OG009554± 251
OG0101220± 701
ParticipantsOG00413
ParticipantsOG0057
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG00079.3± 55.3
OG00175.3± 10.7
OG00290.8± 88.0
OG00367.9± 32.0
OG00485.1± 34.9
OG00593.5± 67.0
OG00681.1± 32.4
OG00741.8± 13.2
OG00883.2± 28.2
OG00940.2± 22.3
OG01045.0± 25.4
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0096
ParticipantsOG0106
Title
Measurements
OG0075.90± 1.73
OG00828.7± 7.82
OG00958.0± 39.6
OG01073.8± 24.3
3760
± 1380
OG0044320± 2260
OG00511100± 14100
OG0067320± 2700
OG0071670± 453
OG0082320± 779
OG0092480± 1090
OG0102590± 929
Participants
OG004
11
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG000693± 283
OG001568± 233
OG002616± 438
OG003553± 336
OG004638± 283
OG005716± 321
OG006726± 206
OG007584± 181
OG008778± 160
OG009563± 262
OG010609± 261
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG00743.7± 16.1
OG008146± 111
OG009493± 258
OG010752± 304
ParticipantsOG00411
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG00039.7± 43.7
OG00136.0± 25.9
OG00227.3± 12.6
OG00331.7± 25.9
OG00438.8± 21.8
OG00535.0± 25.3
OG00647.3± 19.5
OG00738.3± 25.4
OG00855.1± 26.5
OG00933.2± 16.7
OG01033.7± 12.8
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG00716.8± 9.77
OG00849.7± 19.5
OG009155± 30.5
OG010195± 56.3
4.19
± 2.13
OG0043.47± 0.402
OG0053.21± 0.550
OG0063.04± 0.0935
OG0073.25± 0.375
OG0082.10± 0.451
OG0092.95± 1.13
OG0102.59± 0.567
Participants
OG004
11
ParticipantsOG0057
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG0104
Title
Measurements
OG0002.36± 0.427
OG0012.37± 0.704
OG0022.10± 0.522
OG0032.51± 0.472
OG0042.22± 0.439
OG0052.12± 0.314
OG0061.99± 0.601
OG0073.73± 1.78
OG0082.45± 1.19
OG0093.11± 1.01
OG0101.98± 0.523
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0094
ParticipantsOG0104
Title
Measurements
OG0078.71± 2.32
OG0087.97± 1.24
OG00910.3± 3.94
OG0107.71± 0.408
ParticipantsOG0049
ParticipantsOG0055
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0090
ParticipantsOG0104
Title
Measurements
OG0002.82± 0.757
OG0012.00± 0.0542
OG0022.95± 0.739
OG0032.58± 0.737
OG0042.64± 0.604
OG0052.28± 0.546
OG0062.37± 0.517
OG0073.39± 1.57
OG0082.49± 0.528
OG0102.32± 0.455
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0083
ParticipantsOG0091
ParticipantsOG0101
Title
Measurements
OG00723.2± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG00815.4± 6.92
OG0097.99± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG01015.9± NAStandard deviation could not be calculated as only 1 participant was evaluable.
4.21
± 0.724
OG0043.57± 0.688
OG0053.40± 0.223
OG0063.37± 0.511
OG0073.98± 0.331
OG0083.24± 0.776
OG0094.00± 0.922
OG0103.52± 0.237
Participants
OG004
9
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0094
ParticipantsOG0104
Title
Measurements
OG0004.74± 1.43
OG0014.80± 1.40
OG0023.28± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG0034.20± 1.36
OG0043.61± 1.14
OG0062.91± 0.157
OG0074.04± 2.03
OG0082.67± 1.40
OG0093.69± 1.16
OG0105.21± 1.75
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0103
Title
Measurements
OG00713.2± 2.26
OG00811.4± 6.07
OG0098.49± 2.80
OG01010.3± 5.32
ParticipantsOG0045
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0083
ParticipantsOG0092
ParticipantsOG0102
Title
Measurements
OG0004.51± 1.23
OG0017.23± 5.44
OG0022.07± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG0034.61± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG0042.79± 1.23
OG0054.06± 0.195
OG0063.33± 0.524
OG0075.12± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG0082.58± 0.626
OG0093.44± 0.115
OG0104.38± 2.14
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0084
ParticipantsOG0092
ParticipantsOG0102
Title
Measurements
OG00718.3± 3.23
OG00815.7± 6.62
OG00915.0± 6.27
OG01018.6± 2.76
0.348
± 0.125
OG0040.458± 0.188
OG0050.473± 0.215
OG0060.690± 0.291
OG0070.460± 0.134
OG0080.841± 0.178
OG0090.833± 0.463
OG0100.806± 0.393
Participants
OG004
9
ParticipantsOG0056
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0092
ParticipantsOG0104
Title
Measurements
OG0001.51± 0.248
OG0011.26± 0.152
OG0021.07± 0.142
OG0030.989± 0.353
OG0041.03± 0.339
OG0050.969± 0.297
OG0061.19± 0.472
OG0071.29± 0.572
OG0080.778± 0.102
OG0091.19± 0.324
OG0101.08± 0.316
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0085
ParticipantsOG0095
ParticipantsOG0105
Title
Measurements
OG0070.640± 0.282
OG0080.734± 0.404
OG0091.11± 0.753
OG0100.712± 0.168
ParticipantsOG0044
ParticipantsOG0051
ParticipantsOG0063
ParticipantsOG0071
ParticipantsOG0083
ParticipantsOG0090
ParticipantsOG0104
Title
Measurements
OG0000.899± 0.542
OG0010.588± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG0020.285± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG0030.954± 0.0302
OG0040.546± 0.300
OG0050.499± NAStandard deviation could not be calculated as only 1 participant was evaluable.
OG0060.569± 0.0381
OG0071.56± NAStandard deviation could not be calculated as only 1 participant was evaluable.