A Phase I Study of Oral LGX818 in Adult Patients With Adv... | NCT01436656 | Trialant
NCT01436656
Sponsor
Pfizer
Status
Completed
Last Update Posted
Oct 28, 2024Actual
Enrollment
107Actual
Phase
Phase 1
Conditions
Melanoma and Metastatic Colorectal Cancer
Interventions
LGX818
Countries
United States
Australia
France
Japan
Norway
Spain
Switzerland
Protocol Section
Identification Module
NCT ID
NCT01436656
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLGX818X2101
Secondary IDs
ID
Type
Description
Link
C4221010
Other Identifier
Alias Study Number
2011-000556-42
EudraCT Number
Brief Title
A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma
Official Title
A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Aug 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
Sep 5, 2011Actual
Primary Completion Date
Oct 1, 2012Actual
Completion Date
Nov 7, 2022Actual
First Submitted Date
Apr 14, 2011
First Submission Date that Met QC Criteria
Sep 19, 2011
First Posted Date
Sep 20, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 3, 2023
Results First Submitted that Met QC Criteria
Aug 13, 2024
Results First Posted Date
Oct 28, 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
Aug 13, 2024
Last Update Posted Date
Oct 28, 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
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.
Detailed Description
Not provided
Conditions Module
Conditions
Melanoma and Metastatic Colorectal Cancer
Keywords
BRAF mutant,
BRAF mutated,
melanoma,
metastatic,
advanced,
RAF kinase inhibitor
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
107Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LGX818 - Dose escalation
Experimental
Drug: LGX818
LGX818 - Dose Expansion at MTD or RP2D
Experimental
Drug: LGX818
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LGX818
Drug
LGX818 - Dose Expansion at MTD or RP2D
LGX818 - Dose escalation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicity (DLT) During Dose Escalation Phase
DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: >=grade (G)3 neutropenia or thrombocytopenia for >7 days; G4 thrombocytopenia; febrile neutropenia; >=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (>=G3 for > 7 consecutive days or G4); >=G3 ALT or AST and >=G2 blood bilirubin; >=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for >7 consecutive days; >= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; >=G3 pancreatitis, rash/photosensitivity (G3 for > 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.
Up to 28 days
Number of Participants With DLT During Dose Expansion Phase
DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: >=grade (G)3 neutropenia or thrombocytopenia for >7 days; G4 thrombocytopenia; febrile neutropenia; >=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (>=G3 for > 7 consecutive days or G4); >=G3 ALT or AST and >=G2 blood bilirubin; >=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for >7 consecutive days; >= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; >=G3 pancreatitis, rash/photosensitivity (G3 for > 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.
Up to 28 days
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Dose Escalation Phase
An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For the dose escalation phase:
Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]). For the dose expansion phase: (i) Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB to IV per American Joint Committee on Cancer [AJCC]), or (ii) confirmed diagnosis and non-resectable advanced metastatic colorectal cancer (mCRC) for which no further effective standard therapy exists.
Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation.
Evidence of measurable disease
Exclusion Criteria:
Previous therapy with a MEK inhibitor.
Symptomatic or untreated leptomeningeal disease.
Symptomatic or untreated brain metastasis.Patients previously treated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enroll. Brain metastasis must be stable with verification by imaging.
Known acute or chronic pancreatitis.
Clinically significant cardiac disease
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LGX818
Previous or concurrent malignancy. Exceptions to this exclusion criteria include: adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to study entry; or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
History of thromboembolic or cerebrovascular events within the last 6 months
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 CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
H Lee Moffitt Cancer Center and Research Institute
Tampa
Florida
33612
United States
Massachusetts General Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
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.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 107 participants (54 in dose escalation and 53 in dose expansion) were enrolled in this study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG001
Periods
Title
Milestones
Reasons Not Completed
Dose Escalation
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure)
Number of Participants With AEs and SAEs During Dose Expansion Phase
An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.
From start of study treatment until 30 days after last dose of study treatment (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
PFS was defined as time from date of first study treatment intake to date of first documented disease progression (PD) or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of greater than or equal to (>=) 5 mm, or appearance of >=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.
From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)
PFS: Dose Expansion Phase
PFS was defined as time from date of first study treatment intake to date of first documented PD or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.
From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
Duration of Response (DOR): Dose Escalation Phase
DOR was defined as the time from first observation of response CR or partial response [PR]) to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
From first observation of response until first time of PD or death due to any cause (Maximum of 556.1 weeks of treatment exposure)
Time to Response (TTR): Dose Escalation Phase
TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to <10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.
From date of start of treatment until CR or PR or censoring date (maximum of 556.1 weeks of treatment exposure)
DOR: Dose Expansion Phase
DOR was defined as the time from first observation of response (CR or PR] to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to (<10 mm. PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
From first observation of response until first time of PD or death due to any cause (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
TTR: Dose Expansion Phase
TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to <10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.
From date of start of treatment until CR or PR or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
Overall Survival (OS): Dose Expansion Phase
Overall survival was defined as the time from the date of first study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
From start of study treatment until date of death or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
Maximum Observed Plasma Concentration of LGX818: Dose Escalation Phase
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
Time Point of Maximum Concentration (Tmax) of LGX818: Dose Escalation Phase
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of LGX818: Dose Escalation Phase
AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
Area Under the Concentration-Time Curve From Time Zero to Tau (AUCtau) of LGX818: Dose Escalation Phase
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
Elimination Half-life (t1/2) of LGX818: Dose Escalation Phase
t1/2 was the time measured for the plasma concentration to decrease by one half. Terminal phase half-life expressed in hours (hr).
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
Apparent Total Plasma Clearance of Drug (CL/F) of LGX818: Dose Escalation Phase
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
Apparent Volume of Distribution (Vz/F) of LGX818: Dose Escalation Phase
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
Number of Participants According to Tumor Response Per RECIST Criteria- Dose Escalation
Tumor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to <10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)
Maximum Observed Plasma Concentration of LGX818: Dose Expansion Phase
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
Vz/F of LGX818: Dose Expansion Phase
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
Tmax of LGX818: Dose Expansion Phase
Tmax was the time required to reach the maximum plasma concentration (Cmax). First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in hours (hr).
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
AUCinf of LGX818: Dose Expansion Phase
AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
AUCtau of LGX818: Dose Expansion Phase
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
t1/2 of LGX818: Dose Expansion Phase
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
CL/F of LGX818: Dose Expansion Phase
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
Number of Participants According to BRAF V600 Mutation Status at Baseline: Dose Expansion
Number of participants according to BRAF V600 mutation status as V600E (i.e., mutation of the BRAF gene in which valine [V] was substituted by glutamic acid [E] at amino acid 600) or other is reported in this outcome measure.
(Baseline) last non-missing value prior to the first dose (Baseline)
Number of Participants According to Tumor Response Per RECIST Criteria: Dose Expansion
umor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to <10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG002
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG003
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG004
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG005
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG006
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG007
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG008
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG009
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG010
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG011
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG012
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG013
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG014
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
FG015
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
FG016
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
FG017
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
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Type
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FG0030 subjects
FG004
Dose Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0119 subjectsParticipants enrolled in dose expansion phase.
FG0126 subjectsParticipants enrolled in dose expansion phase.
FG0132 subjectsParticipants enrolled in dose expansion phase.
FG01416 subjectsParticipants enrolled in dose expansion phase.
FG0152 subjectsParticipants enrolled in dose expansion phase.
FG0166 subjectsParticipants enrolled in dose expansion phase.
FG01712 subjectsParticipants enrolled in dose expansion phase.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety set included all participants from the full analysis set (all participants who received at least one dose of encorafenib) who had at least one valid post-baseline safety assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
50 mg of Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
BG001
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG002
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG003
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG004
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG005
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG006
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG007
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG008
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG009
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG010
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG011
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG012
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG013
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG014
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
BG015
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
BG016
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
BG017
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG00110
BG0026
BG0033
BG0044
BG0055
BG0065
BG0074
BG0086
BG0095
BG0102
BG0119
BG0126
BG0132
BG01416
BG0152
BG0166
BG01712
BG018107
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
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
Title
Measurements
Caucasian
BG0004
BG00110
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 Toxicity (DLT) During Dose Escalation Phase
DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: >=grade (G)3 neutropenia or thrombocytopenia for >7 days; G4 thrombocytopenia; febrile neutropenia; >=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (>=G3 for > 7 consecutive days or G4); >=G3 ALT or AST and >=G2 blood bilirubin; >=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for >7 consecutive days; >= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; >=G3 pancreatitis, rash/photosensitivity (G3 for > 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.
Dose-Determining Set (DDS) consisted of all participants from the safety set who either met the following minimum exposure (received at least 75% of the planned doses of encorafenib in Cycle 1; observed for at least 1 cycle and considered to have sufficient safety data to conclude that a DLT did not occur in cycle 1) and had completed scheduled safety evaluations or experienced a DLT.
Posted
Count of Participants
Participants
Up to 28 days
ID
Title
Description
OG000
50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
100 mg Encorafenib BID
Units
Counts
Participants
OG0004
OG0019
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG003
Primary
Number of Participants With DLT During Dose Expansion Phase
DLT= Adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within first 28 days of treatment with encorafenib and met any of following criteria: >=grade (G)3 neutropenia or thrombocytopenia for >7 days; G4 thrombocytopenia; febrile neutropenia; >=G3 serum creatinine, blood bilirubin; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) and lipase and/or serum amylase (>=G3 for > 7 consecutive days or G4); >=G3 ALT or AST and >=G2 blood bilirubin; >=G3 persistent hypertension with more than one drug or more intensive therapy or cardiac disorders or AE excluding on-target side-effect that is manageable; G3 fatigue/asthenia for >7 consecutive days; >= G3 vomiting or nausea or diarrhea lasting more than 48 hours despite treatment; >=G3 pancreatitis, rash/photosensitivity (G3 for > 7 consecutive days despite skin toxicity treatment or G4); G3 or G4 eye disorders.
DDS consisted of all participants from the safety set who either met the following minimum exposure criterion (received at least 75% of the planned doses of encorafenib in Cycle 1; observed for at least 1 cycle and considered to have sufficient safety data to conclude that a DLT did not occur in cycle 1) and had completed scheduled safety evaluations or experienced a DLT.
Posted
Count of Participants
Participants
Up to 28 days
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Dose Escalation Phase
An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.
Safety set included all participants who received at least one dose of encorafenib and had at least one valid post-baseline safety assessment.
Posted
Count of Participants
Participants
From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure)
ID
Title
Description
OG000
50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
100 mg Encorafenib QD
Secondary
Number of Participants With AEs and SAEs During Dose Expansion Phase
An AE was defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions. An SAE was defined as one of the following: fatal or life-threatening; resulted in significant disability/incapacity; congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization unless for routine treatment, elective or pre-planned treatment for a pre-existing condition, treatment on an emergency outpatient basis, social reasons and respite care in the absence of any deterioration in the participants general condition, any SAEs that were expected due to the condition being treated.
Safety set included all participants who received at least one dose of encorafenib and had at least one valid post-baseline safety assessment.
Posted
Count of Participants
Participants
From start of study treatment until 30 days after last dose of study treatment (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
PFS was defined as time from date of first study treatment intake to date of first documented disease progression (PD) or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of greater than or equal to (>=) 5 mm, or appearance of >=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.
Full Analysis Set (FAS) included all participants who received at least one dose of encorafenib.
Posted
Median
95% Confidence Interval
Months
From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)
ID
Title
Description
OG000
50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Secondary
PFS: Dose Expansion Phase
PFS was defined as time from date of first study treatment intake to date of first documented PD or death due to any cause. If a participant did not have an event, data censoring was done at the date of last adequate tumor assessment. PD was defined for target disease as at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study (this included baseline sum if that was smallest on study), sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. Analysis was performed using Kaplan-Meier method.
FAS included all participants who received at least one dose of encorafenib.
Posted
Median
95% Confidence Interval
Months
From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Secondary
Duration of Response (DOR): Dose Escalation Phase
DOR was defined as the time from first observation of response CR or partial response [PR]) to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
FAS included all participants who received at least one dose of encorafenib. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis.
Posted
Median
95% Confidence Interval
Months
From first observation of response until first time of PD or death due to any cause (Maximum of 556.1 weeks of treatment exposure)
ID
Title
Description
OG000
50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Time to Response (TTR): Dose Escalation Phase
TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to <10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.
FAS included all participants who received at least one dose of encorafenib.'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis.
Posted
Number
Days
From date of start of treatment until CR or PR or censoring date (maximum of 556.1 weeks of treatment exposure)
ID
Title
Description
OG000
50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Secondary
DOR: Dose Expansion Phase
DOR was defined as the time from first observation of response (CR or PR] to the first time of progression or death. CR was defined as complete disappearance of all target and non-target lesions and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to (<10 mm. PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
FAS included all participants who received at least one dose of encorafenib.'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis.
Posted
Median
95% Confidence Interval
Months
From first observation of response until first time of PD or death due to any cause (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
TTR: Dose Expansion Phase
TTR was defined as the time from date of treatment until first documented response (CR or PR). CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to <10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival. Individual participant data have been reported for this outcome measure.
FAS included all participants who received at least one dose of encorafenib. 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Only participants with complete or partial response were included in the analysis.
Posted
Number
Days
From date of start of treatment until CR or PR or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Overall Survival (OS): Dose Expansion Phase
Overall survival was defined as the time from the date of first study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
FAS included all participants who received at least one dose of encorafenib.
Posted
Median
95% Confidence Interval
Months
From start of study treatment until date of death or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Secondary
Maximum Observed Plasma Concentration of LGX818: Dose Escalation Phase
Pharmacokinetic Analysis Set (PAS) consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
ID
Title
Description
OG000
50 mg Encorafenib QD (Capsules)
Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
50 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
100 mg Encorafenib QD (Capsules)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Time Point of Maximum Concentration (Tmax) of LGX818: Dose Escalation Phase
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Median
Full Range
Hours
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
ID
Title
Description
OG000
50 mg Encorafenib QD (Capsules)
Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
50 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
100 mg Encorafenib QD (Capsules)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of LGX818: Dose Escalation Phase
AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*Nanogram per milliliter
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
ID
Title
Description
OG000
50 mg Encorafenib QD (Capsules)
Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
50 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
100 mg Encorafenib QD (Capsules)
Secondary
Area Under the Concentration-Time Curve From Time Zero to Tau (AUCtau) of LGX818: Dose Escalation Phase
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*Nanogram per milliliter
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
ID
Title
Description
OG000
50 mg Encorafenib QD (Capsules)
Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
50 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
100 mg Encorafenib QD (Capsules)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Elimination Half-life (t1/2) of LGX818: Dose Escalation Phase
t1/2 was the time measured for the plasma concentration to decrease by one half. Terminal phase half-life expressed in hours (hr).
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Median
Full Range
Hours
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
ID
Title
Description
OG000
50 mg Encorafenib QD (Capsules)
Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
50 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
100 mg Encorafenib QD (Capsules)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Apparent Total Plasma Clearance of Drug (CL/F) of LGX818: Dose Escalation Phase
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter/hour
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
ID
Title
Description
OG000
50 mg Encorafenib QD (Capsules)
Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
50 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
100 mg Encorafenib QD (Capsules)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Apparent Volume of Distribution (Vz/F) of LGX818: Dose Escalation Phase
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
Pre-dose (0 hour), 0.5, 3, 4, 6, 8, 10 (only for BID arms), 24 hours post dose on Day 1 and 15 of Cycle 1 (each cycle=28 days)
ID
Title
Description
OG000
50 mg Encorafenib QD (Capsules)
Participants received 50 mg of LGX818 capsule orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
50 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
100 mg Encorafenib QD (Capsules)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Number of Participants According to Tumor Response Per RECIST Criteria- Dose Escalation
Tumor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to <10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
FAS included all participants who received at least one dose of encorafenib.
Posted
Count of Participants
Participants
From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 556.1 weeks of treatment exposure)
ID
Title
Description
OG000
50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 milligram (mg) encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Maximum Observed Plasma Concentration of LGX818: Dose Expansion Phase
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanogram per milliliter
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Vz/F of LGX818: Dose Expansion Phase
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. 'Overall Number of Participants Analyzed' signifies number of participants with evaluable data for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Tmax of LGX818: Dose Expansion Phase
Tmax was the time required to reach the maximum plasma concentration (Cmax). First observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in hours (hr).
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Median
Full Range
Hours
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Secondary
AUCinf of LGX818: Dose Expansion Phase
AUC (inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. 'Overall Number of Participants Analyzed' signifies number of participants with evaluable data for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*Nanogram per milliliter
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Secondary
AUCtau of LGX818: Dose Expansion Phase
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours*nanogram per milliliter
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
t1/2 of LGX818: Dose Expansion Phase
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Median
Full Range
Hours
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
CL/F of LGX818: Dose Expansion Phase
PAS consisted of all participants who had at least one blood sample providing evaluable pharmacokinetic (PK) data. 'Overall Number of Participants Analyzed' signifies number of participants with evaluable data for this outcome measure. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Geometric Mean
Geometric Coefficient of Variation
liter/hour
Predose (0 hour), 0.5, 2, 4, 6, 8, 24 hours post dose on Day 1,8 and 15 of Cycle 1 (cycle=28 days)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Number of Participants According to BRAF V600 Mutation Status at Baseline: Dose Expansion
Number of participants according to BRAF V600 mutation status as V600E (i.e., mutation of the BRAF gene in which valine [V] was substituted by glutamic acid [E] at amino acid 600) or other is reported in this outcome measure.
FAS included all participants who received at least one dose of Encorafenib
Posted
Count of Participants
Participants
(Baseline) last non-missing value prior to the first dose (Baseline)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Secondary
Number of Participants According to Tumor Response Per RECIST Criteria: Dose Expansion
umor response included: CR, PR, stable disease and disease progression (PD). CR=complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to <10 mm. PR=at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. For target disease, PD=at least a 20% increase in sum of longest diameters of all measured target lesions, taking as reference smallest sum on study, sum also demonstrated absolute increase of >= 5 mm, or appearance of >=1 new lesions. For non-target disease: PD=unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion.
FAS included all participants who received at least one dose of encorafenib.
Posted
Count of Participants
Participants
From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively)
ID
Title
Description
OG000
Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Time Frame
From start of study treatment until 30 days after last dose of study treatment (maximum of 556.1 weeks of treatment exposure) for Dose escalation arms and (maximum of 257.3 weeks and 114.6 weeks of treatment exposure for melanoma participants and mCRC participants respectively) for Dose expansion arms.
Description
Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participants, or one participant may have experienced both serious and non-serious event during the study.
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
Dose Escalation: 50 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 50 mg encorafenib (LGX818) orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
1
4
3
4
4
4
EG001
Dose Escalation: 100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
3
10
7
10
10
10
EG002
Dose Escalation:150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
1
6
3
6
6
6
EG003
Dose Escalation: 75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
0
3
2
3
3
3
EG004
Dose Escalation: 200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
1
4
4
4
4
4
EG005
Dose Escalation: 100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
1
5
2
5
5
5
EG006
Dose Escalation: 300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
2
5
4
5
5
5
EG007
Dose Escalation: 150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
1
4
2
4
4
4
EG008
Dose Escalation: 450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
1
6
2
6
6
6
EG009
Dose Escalation: 550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
0
5
3
5
5
5
EG010
Dose Escalation: 700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
0
2
1
2
2
2
EG011
Dose Expansion: Mel Naive 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
2
9
2
9
8
9
EG012
Dose Expansion: Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
11
16
9
16
15
16
EG015
Dose Expansion: Mel Stepwise 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
1
2
2
2
2
2
EG016
Dose Expansion: Metastatic Colorectal Cancer 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
5
6
3
6
6
6
EG017
Dose Expansion: Metastatic Colorectal Cancer 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
8
12
6
12
12
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0061 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0021 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
General physical health deterioration
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Multi-organ failure
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hepatic pain
Hepatobiliary disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Brain herniation
Injury, poisoning and procedural complications
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dysplastic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Facial paresis
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected10 at risk
EG0020 affected6 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Seizure
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Face oedema
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Device related infection
Infections and infestations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Localised infection
Infections and infestations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Septic shock
Infections and infestations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Squamous cell carcinoma of head and neck
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Migraine
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0013 affected10 at risk
EG0022 affected6 at risk
EG0030 affected3 at risk
EG0040 affected4 at risk
EG0051 affected5 at risk
EG0061 affected5 at risk
EG0071 affected4 at risk
EG0081 affected6 at risk
EG0091 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0132 affected2 at risk
EG0141 affected16 at risk
EG0151 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected10 at risk
EG0020 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Ichthyosis
Congenital, familial and genetic disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Keratosis follicular
Congenital, familial and genetic disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0012 affected10 at risk
EG0021 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0013 affected10 at risk
EG0022 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0013 affected10 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0003 affected4 at risk
EG0013 affected10 at risk
EG0022 affected6 at risk
EG003
Chills
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0012 affected10 at risk
EG0022 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Xerosis
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0015 affected10 at risk
EG0021 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0012 affected10 at risk
EG0020 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0012 affected10 at risk
EG0020 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected10 at risk
EG0024 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected10 at risk
EG0023 affected6 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected10 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0003 affected4 at risk
EG0014 affected10 at risk
EG0023 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0022 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0021 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0022 affected6 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0003 affected4 at risk
EG0013 affected10 at risk
EG0020 affected6 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0012 affected10 at risk
EG0022 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0013 affected10 at risk
EG0020 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0021 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Acanthosis nigricans
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected10 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0003 affected4 at risk
EG0014 affected10 at risk
EG0022 affected6 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0013 affected10 at risk
EG0020 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0021 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0014 affected10 at risk
EG0022 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0013 affected10 at risk
EG0024 affected6 at risk
EG003
Hair texture abnormal
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0013 affected10 at risk
EG0020 affected6 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0003 affected4 at risk
EG0017 affected10 at risk
EG0022 affected6 at risk
EG003
Hypotrichosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected10 at risk
EG0022 affected6 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Keratosis pilaris
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0003 affected4 at risk
EG0014 affected10 at risk
EG0021 affected6 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0003 affected4 at risk
EG0016 affected10 at risk
EG0022 affected6 at risk
EG003
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0013 affected10 at risk
EG0020 affected6 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected10 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0017 affected10 at risk
EG0022 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected10 at risk
EG0021 affected6 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0012 affected10 at risk
EG0022 affected6 at risk
EG003
Rash follicular
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0020 affected6 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected10 at risk
EG0022 affected6 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 at risk
EG003
Oral hyperkeratosis
Gastrointestinal disorders
MedDRA 18.1
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected10 at risk
EG0020 affected6 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.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D008545
Melanoma
D015179
Colorectal Neoplasms
D009362
Neoplasm Metastasis
Ancestor Terms
ID
Term
D018358
Neuroendocrine Tumors
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D009380
Neoplasms, Nerve Tissue
D018326
Nevi and Melanomas
D012878
Skin Neoplasms
D009371
Neoplasms by Site
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D007414
Intestinal Neoplasms
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D004066
Digestive System Diseases
D005767
Gastrointestinal Diseases
D003108
Colonic Diseases
D007410
Intestinal Diseases
D012002
Rectal Diseases
D009385
Neoplastic Processes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000601108
encorafenib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0113 subjects
FG0120 subjects
FG0131 subjects
FG0148 subjects
FG0152 subjects
FG0162 subjects
FG0174 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0116 subjects
FG0126 subjects
FG0131 subjects
FG0148 subjects
FG0150 subjects
FG0164 subjects
FG0178 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0123 subjects
FG0131 subjects
FG0142 subjects
FG0150 subjects
FG0161 subjects
FG0171 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0143 subjects
FG0150 subjects
FG0163 subjects
FG0173 subjects
Lost to Follow-up
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
FG0150 subjects
FG0160 subjects
FG0173 subjects
Disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0113 subjects
FG0121 subjects
FG0130 subjects
FG0141 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
New cancer therapy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0121 subjects
FG0130 subjects
FG0142 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
Between 18 and 44 years
BG0001
BG0013
BG0021
BG0031
BG0044
BG0050
BG0061
BG0073
BG0083
BG0090
BG0100
BG0110
BG0121
BG0130
BG0147
BG0151
BG0160
BG0171
BG01827
Between 45 and 64 years
BG0003
BG0014
BG0023
BG0031
BG0040
BG0055
BG0061
BG0071
BG0082
BG0094
BG0101
BG0117
BG0123
BG0130
BG0144
BG0151
BG0164
BG0177
BG01851
>=65 years
BG0000
BG0013
BG0022
BG0031
BG0040
BG0050
BG0063
BG0070
BG0081
BG0091
BG0101
BG0112
BG0122
BG0132
BG0145
BG0150
BG0162
BG0174
BG01829
2
BG0030
BG0042
BG0050
BG0061
BG0072
BG0084
BG0091
BG0101
BG0114
BG0121
BG0131
BG01413
BG0151
BG0163
BG0177
BG01848
Male
BG0002
BG0017
BG0024
BG0033
BG0042
BG0055
BG0064
BG0072
BG0082
BG0094
BG0101
BG0115
BG0125
BG0131
BG0143
BG0151
BG0163
BG0175
BG01859
6
BG0033
BG0044
BG0054
BG0065
BG0074
BG0086
BG0094
BG0102
BG0116
BG0125
BG0131
BG01416
BG0152
BG0166
BG01712
BG018100
Others
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0091
BG0100
BG0113
BG0121
BG0131
BG0140
BG0150
BG0160
BG0170
BG0187
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
3
OG0043
OG0054
OG0065
OG0073
OG0086
OG0094
OG0102
0
OG0040
OG0051
OG0061
OG0071
OG0080
OG0091
OG0102
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0009
OG0012
OG0021
OG00313
OG0042
OG0055
OG00612
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0020
OG0034
OG0041
OG0050
OG0063
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
OG002
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0004
OG00110
OG0026
OG0033
OG0044
OG0055
OG0065
OG0074
OG0086
OG0095
OG0102
Title
Denominators
Categories
Adverse Events (AEs)
Title
Measurements
OG0004
OG00110
OG0026
OG0033
OG0044
OG0055
OG0065
OG0074
OG0086
OG0095
OG0102
Serious Adverse Events (SAEs)
Title
Measurements
OG0003
OG0017
OG0023
OG003
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0009
OG0016
OG0022
OG00316
OG0042
OG0056
OG00612
Title
Denominators
Categories
Adverse Events (AEs)
Title
Measurements
OG0009
OG0016
OG0022
OG00316
OG0042
OG0056
OG00612
Serious Adverse Events (SAEs)
Title
Measurements
OG0002
OG0014
OG0022
OG003
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
OG002
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0004
OG00110
OG0026
OG0033
OG0044
OG0055
OG0065
OG0074
OG0086
OG0095
OG0102
Title
Denominators
Categories
Title
Measurements
OG00075.0(19.4 to 99.4)
OG00110.0(0.3 to 44.5)
OG00250.0(11.8 to 88.2)
OG00333.3(0.8 to 90.6)
OG00450.0(6.8 to 93.2)
OG00540.0(5.3 to 85.3)
OG0060.0(0.0 to 52.2)
OG00775.0(19.4 to 99.4)
OG00833.3(4.3 to 77.7)
OG00920.0(0.5 to 71.6)
OG0100.0(0.0 to 84.2)
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0009
OG0016
OG0022
OG00316
OG0042
OG0056
OG00612
Title
Denominators
Categories
Title
Measurements
OG00016.5(7.4 to NA)Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
OG00119.3(7.4 to NA)Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
OG0020.6(0.6 to NA)Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
OG0032.0(1.6 to 3.7)
OG00420.1(10.9 to NA)Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
OG0054.5(2.3 to 7.2)
OG0064.0(1.8 to 5.5)
OG001
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
OG002
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0011
OG0023
OG0031
OG0042
OG0052
OG0060
OG0073
OG0082
OG0091
OG0100
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG001NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG002NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG003NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG004NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG005NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG007NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG008NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG009NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
OG002
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0011
OG0023
OG0031
OG0042
OG0052
OG0060
OG0073
OG0082
OG0091
OG0100
Title
Denominators
Categories
Participant 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00057
Participant 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Participant 5
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Participant 6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Participant 7
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Participant 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 9
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 10
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 11
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 13
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Participant 14
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 17
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 18
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0007
OG0012
OG0020
OG0034
OG0041
OG0051
OG0060
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG001NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG003NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG004NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG005NA(NA to NA)Median and 95% CI could not be calculated due to insufficient number of participants with events.
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0007
OG0012
OG0020
OG0034
OG0041
OG0051
OG0060
Title
Denominators
Categories
Participant 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000211
Participant 2
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 3
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 4
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 5
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 6
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 7
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 8
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Participant 9
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Participant 10
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Participant 11
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Participant 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Participant 13
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Participant 14
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participant 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0009
OG0016
OG0022
OG00316
OG0042
OG0056
OG00612
Title
Denominators
Categories
Title
Measurements
OG000NA(11.6 to NA)Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
OG00112.5(7.7 to NA)Upper limit of 95% CI could not be calculated due to insufficient number of participants with events
OG002NA(2.4 to NA)Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
OG0039.5(3.7 to 13.2)
OG004NA(30.7 to NA)Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
OG0057.2(5.6 to 10.5)
OG0068.0(4.0 to NA)Upper limit of 95% CI could not be calculated due to insufficient number of participants with events
OG003
100 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
100 mg of Encorafenib BID (Microemulsion)
Participants received 200 mg of LGX818 orally once daily for each 28-day treatment cycle until disease progression, withdrawal of consent, unacceptable toxicity, or termination of treatment, followed by a 30-day safety assessment for toxicity.
OG008
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG011
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG012
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0035
OG0046
OG0053
OG0064
OG0075
OG0085
OG0094
OG0106
OG0115
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0085
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0122
Title
Measurements
OG000970± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed
OG001846± 82.92
OG0021630± 42.36
OG003
Cycle 1 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0035
OG003
100 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG011
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG012
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0035
OG0046
OG0053
OG0064
OG0075
OG0085
OG0094
OG0106
OG0115
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0085
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0122
Title
Measurements
OG0002(2 to 2)
OG0010.5(0.167 to 0.500)
OG0022(0.5 to 2)
OG003
Cycle 1 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0035
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) capsules orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
100 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG011
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG012
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0035
OG0046
OG0053
OG0064
OG0075
OG0085
OG0094
OG0106
OG0115
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0122
Title
Measurements
OG0005470± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG0012340± 70.37
OG0027660± 83.44
OG003
Cycle 1 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
OG003
100 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG011
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG012
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0035
OG0046
OG0053
OG0064
OG0075
OG0085
OG0094
OG0106
OG0115
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0085
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0122
Title
Measurements
OG0005360± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG0012330± 69.89
OG0027610± 82.98
OG003
Cycle 1 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
OG003
100 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG011
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG012
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0035
OG0046
OG0053
OG0064
OG0075
OG0085
OG0094
OG0106
OG0115
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0122
Title
Measurements
OG0004.38(4.38 to 4.38)
OG0013.77(3.57 to 4.44)
OG0023.47(3.38 to 3.88)
OG003
Cycle 1 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
OG003
100 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG011
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG012
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0035
OG0046
OG0053
OG0064
OG0075
OG0085
OG0094
OG0106
OG0115
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0122
Title
Measurements
OG0009.14± NAThe geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG00121.3± 70.37
OG00213± 83.44
OG003
Cycle 1 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
OG003
100 mg Encorafenib QD (Microemulsion)
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib (LGX818) as microemulsion orally once daily (QD) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG011
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG012
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0035
OG0046
OG0053
OG0064
OG0075
OG0085
OG0094
OG0106
OG0115
OG0122
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0035
ParticipantsOG0045
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0122
Title
Measurements
OG00057.8± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG001120± 56.42
OG00267± 79.38
OG003
Cycle 1 Day 15
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
OG001
100 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity
OG002
150 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
75 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 75 mg encorafenib orally twice daily (BID) in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
200 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 200 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG005
100 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 100 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG006
300 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 300 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG007
150 mg Encorafenib BID
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 150 mg encorafenib twice daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG008
450 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG009
550 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 550 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG010
700 mg Encorafenib QD
Participants with advanced or metastatic melanoma harboring BRAF V600 (E, K, D, R) mutations received 700 mg encorafenib orally once daily in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
Units
Counts
Participants
OG0004
OG00110
OG0026
OG0033
OG0044
OG0055
OG0065
OG0074
OG0086
OG0095
OG0102
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0071
OG0080
OG0090
OG0100
Partial Response (PR)
Title
Measurements
OG0002
OG0011
OG0023
OG003
Stable Disease (SD)
Title
Measurements
OG0000
OG0015
OG0021
OG003
Progressive Disease (PD)
Title
Measurements
OG0001
OG0012
OG0022
OG003
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0011
OG0021
OG00310
OG0042
OG0051
OG00610
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG00310
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG00610
Title
Measurements
OG0004310± 31.6
OG0015650± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG0027790± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG003
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0010
OG0021
OG00310
OG0042
OG0051
OG00610
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG00310
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG00610
Title
Measurements
OG00079.1± 29.82
OG00225.3± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG00359.7± 35.42
OG004
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0011
OG0021
OG00310
OG0042
OG0051
OG00610
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG00310
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG00610
Title
Measurements
OG0001.97(1.95 to 1.97)
OG0012.08(2.08 to 2.08)
OG0023.97(3.97 to 3.97)
OG003
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0037
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0010
OG0021
OG00310
OG0042
OG0051
OG00610
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG00310
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG00610
Title
Measurements
OG00018200± 32.37
OG00270900± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG00333300± 39.98
OG004
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0011
OG0021
OG00310
OG0042
OG0051
OG00610
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG00310
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG00610
Title
Measurements
OG00018100± 32.22
OG00135300± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG00269300± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG003
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0011
OG0021
OG00310
OG0042
OG0051
OG00610
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG00310
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG00610
Title
Measurements
OG0003.36(3 to 3.65)
OG0014.04(4.04 to 4.04)
OG0024.14(4.14 to 4.14)
OG003
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0003
OG0010
OG0021
OG00310
OG0042
OG0051
OG00610
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG00310
ParticipantsOG0042
ParticipantsOG0050
ParticipantsOG00610
Title
Measurements
OG00016.5± 32.37
OG0024.23± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG00313.5± 39.98
OG004
Cycle 1 Day 8
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0009
OG0016
OG0022
OG00316
OG0042
OG0056
OG00612
Title
Denominators
Categories
Title
Measurements
V600E
OG0008
OG0015
OG0021
OG00316
OG0041
OG0056
OG00612
Others
OG0001
OG0011
OG0021
OG0030
OG004
OG001
Mel Naive 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations naive to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG002
Mel Pre-treated: 300 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG003
Mel Pre-treated: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations pre-treated to a selective BRAF inhibitor received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or, unacceptable toxicity.
OG004
Mel Stepwise: 450 mg Encorafenib
Participants with advanced melanoma harboring BRAF V600 (E, K, D, R) mutations received 450 mg encorafenib orally QD in a two-step manner in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG005
Metastatic Colorectal Cancer: 300 mg Encorafenib
Participants with metastatic colorectal cancer received 300 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
OG006
Metastatic Colorectal Cancer: 450 mg Encorafenib
Participants with metastatic colorectal cancer received 450 mg encorafenib orally QD in each 28-day treatment cycle until disease progression, withdrawal of consent or unacceptable toxicity.
Units
Counts
Participants
OG0009
OG0016
OG0022
OG00316
OG0042
OG0056
OG00612
Title
Denominators
Categories
Complete Response (CR)
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Partial Response (PR)
Title
Measurements
OG0006
OG0012
OG0020
OG003
Stable Disease (SD)
Title
Measurements
OG0000
OG0011
OG0020
OG003
Progressive Disease (PD)
Title
Measurements
OG0001
OG0010
OG0022
OG003
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0041 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0161 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0061 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0091 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0121 affected6 at risk
EG0131 affected2 at risk
EG0141 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0172 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0071 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0142 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0122 affected6 at risk
EG0130 affected2 at risk
EG0141 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0071 affected4 at risk
EG0081 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0071 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0081 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0061 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0061 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0071 affected4 at risk
EG0081 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
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EG0064 affected5 at risk
EG0071 affected4 at risk
EG0084 affected6 at risk
EG0092 affected5 at risk
EG0101 affected2 at risk
EG0114 affected9 at risk
EG0122 affected6 at risk
EG0130 affected2 at risk
EG01411 affected16 at risk
EG0152 affected2 at risk
EG0164 affected6 at risk
EG0178 affected12 at risk
2 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0061 affected5 at risk
EG0072 affected4 at risk
EG0081 affected6 at risk
EG0091 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0142 affected16 at risk
EG0152 affected2 at risk
EG0160 affected6 at risk
EG0172 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0061 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0151 affected2 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0041 affected4 at risk
EG0050 affected5 at risk
EG0062 affected5 at risk
EG0071 affected4 at risk
EG0081 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
1 affected
3 at risk
EG0041 affected4 at risk
EG0053 affected5 at risk
EG0062 affected5 at risk
EG0071 affected4 at risk
EG0082 affected6 at risk
EG0091 affected5 at risk
EG0100 affected2 at risk
EG0112 affected9 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0146 affected16 at risk
EG0152 affected2 at risk
EG0163 affected6 at risk
EG0175 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0052 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0142 affected16 at risk
EG0150 affected2 at risk
EG0162 affected6 at risk
EG0174 affected12 at risk
0 affected
3 at risk
EG0042 affected4 at risk
EG0050 affected5 at risk
EG0061 affected5 at risk
EG0070 affected4 at risk
EG0081 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0121 affected6 at risk
EG0131 affected2 at risk
EG0141 affected16 at risk
EG0151 affected2 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0041 affected4 at risk
EG0050 affected5 at risk
EG0061 affected5 at risk
EG0071 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
1 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0061 affected5 at risk
EG0071 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0051 affected5 at risk
EG0061 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0091 affected5 at risk
EG0100 affected2 at risk
EG0113 affected9 at risk
EG0121 affected6 at risk
EG0131 affected2 at risk
EG0141 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0172 affected12 at risk
0 affected
3 at risk
EG0041 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0081 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected16 at risk
EG0151 affected2 at risk
EG0160 affected6 at risk
EG0172 affected12 at risk
0 affected
3 at risk
EG0041 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0081 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0151 affected2 at risk
EG0161 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0142 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0172 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0122 affected6 at risk
EG0131 affected2 at risk
EG0141 affected16 at risk
EG0151 affected2 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0131 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0172 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0121 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0121 affected6 at risk
EG0131 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0142 affected16 at risk
EG0150 affected2 at risk
EG0161 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0121 affected6 at risk
EG0131 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0131 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected16 at risk
EG0150 affected2 at risk
EG0161 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0142 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0112 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0161 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected16 at risk
EG0151 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0161 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0113 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0170 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0140 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0172 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0110 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0141 affected16 at risk
EG0150 affected2 at risk
EG0161 affected6 at risk
EG0171 affected12 at risk
0 affected
3 at risk
EG0040 affected4 at risk
EG0050 affected5 at risk
EG0060 affected5 at risk
EG0070 affected4 at risk
EG0080 affected6 at risk
EG0090 affected5 at risk
EG0100 affected2 at risk
EG0111 affected9 at risk
EG0120 affected6 at risk
EG0130 affected2 at risk
EG0142 affected16 at risk
EG0150 affected2 at risk
EG0160 affected6 at risk
EG0171 affected12 at risk
2
OG0044
OG0052
OG0064
OG0072
OG0082
OG0093
OG0101
9
OG0042
OG0053
OG0066
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG000952
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00022
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00155
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG002897
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00221
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00272
Participants
OG004
1
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00427
Participants
OG004
1
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00457
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00857
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG008627
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG00956
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00328
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG005280
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00522
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00722
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00729
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG007727
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00022
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00023
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00022
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00056
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00023
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00056
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00178
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG001111
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG003391
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00322
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00332
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00328
Participants
OG004
1
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG00425
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0060
Title
Measurements
OG00553
1020
± 49.06
OG0041570± 28.82
OG005733± 46.32
OG0061850± 28.06
OG0071200± 28.06
OG0083310± 42.54
OG0092510± 58.15
OG0105970± 56.35
OG0115360± 36.87
OG0128980± 13.5
Participants
OG004
5
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0113
ParticipantsOG0122
Title
Measurements
OG000465± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed
OG001334± 57.7
OG002959± 25.19
OG003949± 27.4
OG0041300± 29.08
OG005NA± NAData could not be estimated as values were below limit of quantitation.
OG0061300± 1220
OG007NA± NAData could not be estimated as values were below limit of quantitation.
OG0082920± 34.41
OG009NA± NAData could not be estimated as values were below limit of quantitation.
OG0103950± 49.12
OG0114170± 48.94
OG012NA± NAData could not be estimated as values were below limit of quantitation.
2
(0.5 to 2)
OG0042(0.517 to 3.95)
OG0052.02(2 to 4.08)
OG0062(2 to 2)
OG0072(2 to 2.08)
OG0082(2 to 8)
OG0091.25(0.5 to 2.25)
OG0102(2 to 2.33)
OG0112(2 to 2.07)
OG0122.04(2 to 2.08)
Participants
OG004
5
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0113
ParticipantsOG0122
Title
Measurements
OG0002(2 to 2)
OG0010.5(0.5 to 2)
OG0022.99(2 to 4)
OG0030.5(0.5 to 0.533)
OG0042(0.5 to 2.03)
OG005NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0062(2 to 2.17)
OG007NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0082(2 to 2.02)
OG009NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0102(0.5 to 2)
OG0112(2 to 2)
OG012NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
5050
± 39.57
OG0049520± 20.11
OG0052220± 53.66
OG0069910± 26.24
OG0074410± 69.51
OG00820000± 33.36
OG0098940± 50
OG01033100± 70.34
OG01131900± 45.51
OG01264400± 1.75
Participants
OG004
6
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0113
ParticipantsOG0122
Title
Measurements
OG0002700± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG0011130± 20.1
OG0025380± 36.87
OG0032900± 37.88
OG0044830± 11.11
OG005NA± NAData could not be estimated as values were below limit of quantitation.
OG0065080± 35.87
OG007NA± NAData could not be estimated as values were below limit of quantitation.
OG00810200± 53.84
OG009NA± NAData could not be estimated as values were below limit of quantitation.
OG01013200± 34.77
OG01115600± 36.58
OG012NA± NAData could not be estimated as values were below limit of quantitation.
5010
± 39.39
OG0049400± 20.06
OG0053210± 92.21
OG0069860± 26.5
OG0074780± 52.49
OG00820300± 29.06
OG0098690± 49.73
OG01032800± 69.05
OG01131700± 45.33
OG01263900± 1.41
Participants
OG004
6
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0113
ParticipantsOG0122
Title
Measurements
OG0002660± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG0011120± 19.67
OG0025330± 36.58
OG0032890± 37.55
OG0044750± 12.25
OG005NA± NAData could not be estimated as values were below limit of quantitation.
OG0065060± 35.79
OG007NA± NAData could not be estimated as values were below limit of quantitation.
OG00810100± 53.35
OG009NA± NAData could not be estimated as values were below limit of quantitation.
OG01013100± 34.85
OG01115300± 36.38
OG012NA± NAData could not be estimated as values were below limit of quantitation.
3.7
(3.32 to 3.96)
OG0043.66(3.09 to 4.5)
OG0052.82(2.02 to 3.84)
OG0063.3(2.56 to 3.58)
OG0072.53(1.69 to 2.68)
OG0083.42(2.84 to 4.77)
OG0092.16(2.16 to 2.42)
OG0102.92(2.32 to 4.98)
OG0113.32(3.28 to 3.61)
OG0123.25(2.96 to 3.53)
Participants
OG004
6
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0113
ParticipantsOG0122
Title
Measurements
OG0004.14(4.14 to 4.14)
OG0013.71(3.66 to 5.63)
OG0023.99(3.22 to 4.05)
OG0033.61(3.26 to 4.1)
OG0043.65(3.43 to 7.47)
OG005NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0063.13(2.95 to 3.22)
OG007NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0083.57(1.61 to 4.06)
OG009NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0103.19(2.82 to 3.56)
OG0113.25(2.96 to 8)
OG012NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
19.8
± 39.57
OG00415.8± 20.11
OG00533.8± 53.66
OG00620.2± 26.24
OG00722.7± 69.51
OG00815± 33.36
OG00916.8± 50
OG01013.6± 70.34
OG01117.2± 45.51
OG01210.9± 1.75
Participants
OG004
6
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0084
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0113
ParticipantsOG0122
Title
Measurements
OG00018.8± NAThe geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG00144.7± 19.67
OG00218.8± 36.58
OG00334.6± 37.55
OG00431.5± 12.25
OG005NA± NAData could not be estimated as values were below limit of quantitation.
OG00639.5± 35.79
OG007NA± NAData could not be estimated as values were below limit of quantitation.
OG00829.6± 53.35
OG009NA± NAData could not be estimated as values were below limit of quantitation.
OG01034.3± 34.85
OG01136± 36.38
OG012NA± NAData could not be estimated as values were below limit of quantitation.
104
± 35.34
OG00484.5± 28.15
OG005116± 27.23
OG00691.9± 39.62
OG00773.8± 39.95
OG00876.5± 33.65
OG00953.9± 49.07
OG01060.5± 53.31
OG01184.8± 41.99
OG01250.7± 10.87
Participants
OG004
5
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0075
ParticipantsOG0085
ParticipantsOG0094
ParticipantsOG0106
ParticipantsOG0115
ParticipantsOG0122
Title
Measurements
OG000112± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG001274± 7.68
OG002103± 36.42
OG003182± 33.22
OG004188± 43.23
OG005NA± NAData could not be estimated as values were below limit of quantitation.
OG006177± 31
OG007NA± NAData could not be estimated as values were below limit of quantitation.
OG008128± 12.49
OG009NA± NAData could not be estimated as values were below limit of quantitation.
OG010157± 38.55
OG011221± 75.92
OG012NA± NAData could not be estimated as values were below limit of quantitation.
1
OG0041
OG0052
OG0060
OG0072
OG0082
OG0091
OG0100
2
OG0040
OG0051
OG0062
OG0070
OG0081
OG0092
OG0101
0
OG0042
OG0051
OG0062
OG0071
OG0082
OG0091
OG0100
6580
± 34.24
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG0051340
OG0068380± 32.93
Participants
OG004
2
ParticipantsOG0050
ParticipantsOG0065
Title
Measurements
OG0001060± 41.1
OG0035590± 22.56
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG0065650± 79.98
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0067
Title
Measurements
OG0002050± 43.71
OG0034960± 32.64
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG0051040± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG0065130± 48.81
NA
± NA
Data could not be estimated as values were below limit of quantitation.
OG00644.6± 26.6
Participants
OG004
2
ParticipantsOG0050
ParticipantsOG0065
Title
Measurements
OG000219± 41.9
OG00366.1± 23.07
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG00670± 40.28
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0067
Title
Measurements
OG000243± 79
OG003130± 20.81
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG005194± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG006110± 32.51
2
(0.5 to 2.12)
OG004NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0062(0.667 to 4)
Participants
OG004
2
ParticipantsOG0050
ParticipantsOG0065
Title
Measurements
OG0001.92(1.9 to 1.98)
OG0031.93(0.5 to 2.07)
OG004NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0062(0.5 to 2)
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0067
Title
Measurements
OG0001.9(1.88 to 1.97)
OG001NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG002NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0032(0.5 to 2.3)
OG004NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0054(4 to 4)
OG0062(1.97 to 2.08)
NA
± NA
Data could not be estimated as values were below limit of quantitation.
OG00654400± 42.97
Participants
OG004
2
ParticipantsOG0050
ParticipantsOG0065
Title
Measurements
OG0004290± 30.9
OG00316600± 23.69
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG00616400± 34.68
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0067
Title
Measurements
OG0002050± 43.71
OG0034960± 32.64
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG0051040± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG00617300± 38.06
33200
± 39.86
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG00654400± 42.97
Participants
OG004
2
ParticipantsOG0050
ParticipantsOG0065
Title
Measurements
OG0004290± 30.9
OG00316600± 23.69
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG00616400± 34.67
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0067
Title
Measurements
OG0007380± 60.51
OG00317600± 25.65
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG00510400± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.
OG00617300± 37.9
3.07
(2.61 to 3.38)
OG004NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0063.63(2.59 to 6.44)
Participants
OG004
2
ParticipantsOG0050
ParticipantsOG0065
Title
Measurements
OG0002.41(1.69 to 2.47)
OG0031.66(1.61 to 1.81)
OG004NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0061.76(1.62 to 1.98)
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0067
Title
Measurements
OG0004.33(3.47 to 4.75)
OG0033.37(2.87 to 4.24)
OG004NA(NA to NA)Data could not be estimated as values were below limit of quantitation.
OG0054.51(4.51 to 4.51)
OG0063.13(1.73 to 4.42)
NA
± NA
Data could not be estimated as values were below limit of quantitation.
OG0068.27± 42.97
Participants
OG004
2
ParticipantsOG0050
ParticipantsOG0065
Title
Measurements
OG00070.1± 30.98
OG00327.2± 23.63
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG00627.4± 34.67
Participants
OG004
2
ParticipantsOG0051
ParticipantsOG0067
Title
Measurements
OG00040.7± 60.51
OG00325.6± 25.65
OG004NA± NAData could not be estimated as values were below limit of quantitation.
OG00529.9± NAGeometric coefficient of variation could not be estimated as only 1 participant was analyzed.