A Phase I/II, Multicenter, Open-label Study of EGFRmut-TK... | NCT02108964 | Trialant
NCT02108964
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Dec 11, 2024Actual
Enrollment
225Actual
Phase
Phase 1Phase 2
Conditions
Advanced Non-small Cell Lung Cancer
Interventions
EGF816
Countries
United States
Canada
Germany
Japan
Netherlands
Singapore
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02108964
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CEGF816X2101
Secondary IDs
ID
Type
Description
Link
2013-004482-14
EudraCT Number
Brief Title
A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
Official Title
A Phase I/II, Multicenter, Open-label Study of EGFRmut-TKI EGF816, Administered Orally in Adult Patients With EGFRmut Solid Malignancies
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Dec 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
Jun 6, 2014Actual
Primary Completion Date
Mar 22, 2018Actual
Completion Date
Aug 15, 2023Actual
First Submitted Date
Apr 7, 2014
First Submission Date that Met QC Criteria
Apr 7, 2014
First Posted Date
Apr 9, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 1, 2020
Results First Submitted that Met QC Criteria
Oct 1, 2020
Results First Posted Date
Oct 26, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 1, 2018
Certification/Extension First Submitted that Passed QC Review
Oct 1, 2018
Certification/Extension First Posted Date
Oct 4, 2018Actual
Last Update Submitted Date
Dec 9, 2024
Last Update Posted Date
Dec 11, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase I/II, multi-center, open-label study, composed with a Phase I part (dose-escalation phase) followed by a Phase II part (expansion phase).
The dose escalation phase was designed to determine as primary objective the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of EGF816 monotherapy in adult subjects with locally advanced (stage IIIB) or metastatic (stage IV) NSCLC harboring specific EGFR mutations. Patients may have or not have received prior lines of antineoplastic therapy. An adaptive Bayesian Logistic Regression Model (BLRM) employing the escalation with overdose control (EWOC) principle will be used during the dose escalation part for dose level selection and MTD recommendation. The primary objective of the Phase II part is to estimate antitumor activity of EGF816 as measured by overall response rate (ORR) determined by Blinded Independent Review Committee (BIRC) assessment in accordance to RECIST 1.1.
Detailed Description
Following completion of screening procedures and confirmation of patient eligibility, the participants are enrolled in the study. The study treatment begin on Cycle 1, Day 1 with the first administration of EGF816. A treatment cycle is defined as 28 days. Oral EGF816 is administered once daily on a continuous schedule until patient experiences unacceptable toxicity, progressive disease (PD), and/or treatment is discontinued at the discretion of the investigator, patient withdrawal of consent, or due to any other reasons. Treatment with EGF816 may be continued beyond RECIST 1.1 defined PD, if, in the judgment of the investigator, there is evidence of clinical benefit and the patient wishes to continue with the study treatment.
Conditions Module
Conditions
Advanced Non-small Cell Lung Cancer
Keywords
NSCLC
Non-small Cell Lung Cancer EGFRmut
EGFR TKIs (EGF816)
acquired T790M mutation
de novo T790M mutation
EGFR TKI activating mutation (i.e. L858R or ex19del)
Treatment naive advanced NSCLC with EGFR activating mutations
Locally advanced NSCLC (Stage IIIB NSCLC not amenable to definitive multi-modality therapy including surgery)
Metastatic NSCLC refers to Stage IV NSCLC
1st line
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
225Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase I part
Experimental
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations will be administered escalated doses of EGF816 orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study. The starting dose for the Phase I part first cohort of patients will be 75 mg once per day capsule.
Drug: EGF816
Phase II part
Experimental
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations will be administered with EGF816 at RP2D during Phase II part of the study.
Drug: EGF816
Interventions
Name
Type
Description
Arm Group Labels
Other Names
EGF816
Drug
EGF816 will be dosed once daily. On the first day of each treatment cycle, the patient receives an adequate drug supply for self-administration at home. The investigator will instruct the patient to take EGF816 exactly as prescribed.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs) (Phase I Part)
Number of participants with DLTs during the first 28 days of therapy. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with EGF816 and meets any of the criteria described in the protocol. A participant with multiple occurrences of DLTs under one treatment is counted only once.
First 28 days of dosing
Overall Response Rate (ORR) by Blinded Independent Review Committee (BIRC) (Phase II Part)
ORR is defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) determined by BIRC assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
From baseline up to 64 weeks
Secondary Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS) by Investigator Assessment (Phase I & Phase II Parts)
PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1
At least 24 weeks up to approx. 9 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria: (For all patients unless otherwise specified)
Histologically or cytologically confirmed locally advanced (stage IIIB not amenable to definitive multi-modality therapy including surgery) or metastatic (stage IV) EGFR mutant NSCLC.
Patients with controlled brain metastases
ECOG performance status: Phase I part: 0, 1, or 2; Phase II part: 0 or 1
Presence of at least one measurable lesion according to RECIST 1.1 per investigator assessment
Patients who are either Hepatitis B surface antigen (HBsAg) positive or hepatitis B virus (HBV)-DNA positive must be willing and able to take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816
Patients must have negative hepatitis C antibody (HCV-Ab) or positive HCV-Ab but undetectable level of HCV-RNA. Note: patients with detectable HCV-RNA are not eligible for the study.
For Phase I: patients must have failed no more than 3 lines of any systemic antineoplastic therapy for advanced NSCLC, including EGFR-TKI
For Phase II: patients must be naïve from any systemic antineoplastic therapy in the advanced setting. Patients who have failed no more than 1 cycle of systemic antineoplastic therapy in the advanced setting are allowed.
Exclusion criteria: (For all patients unless otherwise specified)
Patients with a history or presence of interstitial lung disease (ILD) or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention)
Presence or history of another malignancy
Undergone a bone marrow or solid organ transplant
Known history of human immunodeficiency virus (HIV) seropositivity
Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry except for control of brain metastases, topical applications, inhaled sprays, eye drops or local injections
Patients with clinically significant, uncontrolled heart disease
Any prior therapies ≤ 4 weeks prior to the first dose of study treatment
Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 and cannot be discontinued 1 week prior to the start of EGF816 treatment and for the duration of the study.
Patients who have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of EGF816
Patients who are receiving treatment with any enzyme-inducing anticonvulsant that cannot be discontinued at least 1 week before first dose of study treatment, and for the duration of the study
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping treatment
Other protocol-defined inclusion and exclusion criteria may apply.
Tan DSW, Kim SW, Ponce Aix S, Sequist LV, Smit EF, Yang JCH, Hida T, Toyozawa R, Felip E, Wolf J, Grohe C, Leighl NB, Riely G, Cui X, Zou M, Ghebremariam S, O'Sullivan-Djentuh L, Belli R, Giovannini M, Kim DW. Nazartinib for treatment-naive EGFR-mutant non-small cell lung cancer: Results of a phase 2, single-arm, open-label study. Eur J Cancer. 2022 Sep;172:276-286. doi: 10.1016/j.ejca.2022.05.023. Epub 2022 Jul 7.
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
370 subjects were screened for eligibility during the 28 days prior to starting study treatment on Cycle 1 Day 1 (C1D1). The eligibility assessments were performed and ensured that all inclusion and exclusion criteria were satisfied
Recruitment Details
This is a 2-part study conducted in 14 investigative sites in 9 countries: Phase I part (dose-escalation) and Phase II part (dose expansion)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
FG001
EGF816 100 mg (Phase I Part)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 11, 2020
Aug 15, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Belgium
China
France
Italy
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Phase I part
Phase II part
Nazartinib
Duration of Response (DOR) by Investigator Assessment (Phase I & II Parts)
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1
At least 24 weeks up to approx. 9 years
Observed Maximum Plasma Concentration (Cmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
To characterize the PK properties of EGF816 and metabolite LMI258, Cmax will be calculated (Phase I & II parts).
Cmax is maximum (peak) observed plasma drug concentration (mass x volume-1).
Cycle (C) 1 Day (D) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), C1D15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for Phase I part only) and C2D1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).
Time to Maximum Plasma Concentration (Tmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part). Tmax is the Time to Reach Maximum (Peak) Plasma Drug Concentration (Time).
To characterize the PK properties of EGF816 and metabolite LMI258, Tmax will be calculated (Phase I & II parts). Tmax is the time to reach maximum (peak) plasma drug concentration (time).
Cycle (C) 1 Day (D) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), C1D15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for Phase I part only) and C2D1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
To characterize the PK properties of EGF816 and metabolite LMI258, AUCtau will be calculated (Phase I & II parts). AUCtau is the AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1).
Cycle (C) 1 Day (D) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), C1D15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for Phase I part only) and C2D1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).
Percentage Change From Baseline in H-score for Immunohistochemistry (IHC) Biomarkers From Tumor Tissue Samples (Phase I Part)
Changes in EGFR signaling pathway of newly obtained tumor samples following EGF816 treatment were evaluated by IHC of three pharmacodynamics (PD) biomarkers: p-EGFR, p-AKT and p-ERK. The assigned H-score semi-quantitatively assessed the expression level of these protein markers and their phosphorylated forms.
Baseline and Cycle 1 Day 15
Overall Response Rate (ORR) by Investigator Assessment (Phase I & II Parts)
ORR is defined as percentage of patients with best overall response of partial response (PR)+ complete response (CR) determined by Investigator assessment in accordance to RECIST 1.1
At least 24 weeks up to approx. 4 years
Disease Control Rate (DCR) by Investigator Assessment (Phase I & II Parts)
DCR is defined as the proportion of patients with best overall response of CR, PR, or SD determined by Investigator assessment in accordance to RECIST 1.1
At least 24 weeks up to approx. 4 years
Time to Response (TTR) by Investigator Assessment (Phase I & II Parts)
TTR is defined as the time from the date of the first dose to the date of first documented response (CR or PR) determined by Investigator assessment in accordance to RECIST 1.1
At least 24 weeks up to approx. 9 years
Number of Participants With Dose Interruptions and Dose Reductions (Phase I & II Parts)
Assessment of the tolerability of EGF816 will be performed continuously during the treatment phase
At least 24 weeks up to approx. 9 years
Duration of Response (DOR) by BIRC (Phase II Part)
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by BIRC in accordance to RECIST 1.1
At least 24 weeks up to approx. 9 years
Disease Control Rate (DCR) by BIRC (Phase II Part)
DCR is defined as the percentage of patients with best overall response of CR, PR, or SD determined by BIRC in accordance to RECIST 1.1
At least 24 weeks up to approx. 9 years
Progression-Free Survival (PFS) by BIRC (Phase II Part)
PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by BIRC in accordance to RECIST 1.1
At least 24 weeks up to approx. 9 years
Time to Response (TTR) by BIRC (Phase II Part)
TTR is defined as as the time from the date of first dose of study treatment to the date of first documented response (CR or PR) determined by by BIRC in accordance to RECIST 1.1
At least 24 weeks up to approx. 9 years
Overall Survival (OS) (Phase II Part)
OS is defined as the time from first dose of the study treatment to the date of death due to any cause.
At least 24 weeks up to approx. 9 years
New York
New York
10017
United States
Novartis Investigative Site
Toronto
Ontario
M5G 2M9
Canada
Novartis Investigative Site
Berlin
13125
Germany
Novartis Investigative Site
Cologne
50937
Germany
Novartis Investigative Site
Nagoya
Aichi-ken
464 8681
Japan
Novartis Investigative Site
Fukuoka
Fukuoka
811-1395
Japan
Novartis Investigative Site
Zoetermeer
NL-2722 EP
Netherlands
Novartis Investigative Site
Singapore
168583
Singapore
Novartis Investigative Site
Seoul
03080
South Korea
Novartis Investigative Site
Seoul
05505
South Korea
Novartis Investigative Site
Barcelona
Catalonia
08035
Spain
Novartis Investigative Site
Madrid
28041
Spain
Novartis Investigative Site
Taipei
10002
Taiwan
Derived
Tan DS, Leighl NB, Riely GJ, Yang JC, Sequist LV, Wolf J, Seto T, Felip E, Aix SP, Jonnaert M, Pan C, Tan EY, Ko J, Moody SE, Kim DW. Safety and efficacy of nazartinib (EGF816) in adults with EGFR-mutant non-small-cell lung carcinoma: a multicentre, open-label, phase 1 study. Lancet Respir Med. 2020 Jun;8(6):561-572. doi: 10.1016/S2213-2600(19)30267-X. Epub 2020 Jan 15.
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
FG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
FG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
FG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
FG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
FG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
FG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
FG00017 subjects
FG00138 subjects
FG00273 subjects
FG0038 subjects
FG00428 subjects
FG0055 subjects
FG00611 subjects
FG00745 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG00017 subjects
FG00138 subjects
FG00273 subjects
FG0038 subjects
FG00428 subjects
FG0055 subjects
FG00611 subjects
FG00745 subjects
Type
Comment
Reasons
Progressive disease
FG00015 subjects
FG00131 subjects
FG00254 subjects
FG0037 subjects
FG00420 subjects
FG0054 subjects
FG0066 subjects
FG00733 subjects
Physician Decision
FG0001 subjects
FG0015 subjects
FG0027 subjects
FG0031 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0030 subjects
FG004
Subject/Guardian decision
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0030 subjects
FG004
Study terminated by Sponsor: remaining participants benefiting from drug were transitioned to PSDS
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Full Analysis Set (FAS): The full analysis set (FAS) includes all subjects who received at least one dose of EGF816.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
BG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
BG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
BG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
BG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
BG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
BG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
BG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00017
BG00138
BG00273
BG0038
BG00428
BG0055
BG00611
BG00745
BG008225
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00123
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG00013
BG00122
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) (Phase I Part)
Number of participants with DLTs during the first 28 days of therapy. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with EGF816 and meets any of the criteria described in the protocol. A participant with multiple occurrences of DLTs under one treatment is counted only once.
Dose-determining set (DDS) including all patients who received at least one dose of EGF816 in the dose escalation phase who had met the minimum safety evaluation requirements (observed for ≥ 28 days following the first dose) and the minimum exposure criterion (at least 75% of the planned doses of EGF816) or discontinue earlier due to DLTs
Posted
Count of Participants
Participants
First 28 days of dosing
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
Units
Counts
Participants
OG00016
OG00138
OG00269
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG003
Primary
Overall Response Rate (ORR) by Blinded Independent Review Committee (BIRC) (Phase II Part)
ORR is defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) determined by BIRC assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Full Analysis Set (FAS) including participants who received at least one dose of EGF816
Posted
Number
95% Confidence Interval
Percentage of participants
From baseline up to 64 weeks
ID
Title
Description
OG000
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG000
Secondary
Progression-free Survival (PFS) by Investigator Assessment (Phase I & Phase II Parts)
PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1
Full Analysis Set (FAS) including participants who received at least one dose of EGF816
Posted
Median
95% Confidence Interval
Months
At least 24 weeks up to approx. 9 years
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
Secondary
Duration of Response (DOR) by Investigator Assessment (Phase I & II Parts)
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1
Full Analysis Set (FAS) including participants who received at least one dose of EGF816
Posted
Median
95% Confidence Interval
Months
At least 24 weeks up to approx. 9 years
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
Secondary
Observed Maximum Plasma Concentration (Cmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
To characterize the PK properties of EGF816 and metabolite LMI258, Cmax will be calculated (Phase I & II parts).
Cmax is maximum (peak) observed plasma drug concentration (mass x volume-1).
Pharmacokinetics Analysis Set (PAS) The PAS consists of all subjects who received at least one dose of EGF816 and have at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle (C) 1 Day (D) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), C1D15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for Phase I part only) and C2D1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG002
Secondary
Time to Maximum Plasma Concentration (Tmax) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part). Tmax is the Time to Reach Maximum (Peak) Plasma Drug Concentration (Time).
To characterize the PK properties of EGF816 and metabolite LMI258, Tmax will be calculated (Phase I & II parts). Tmax is the time to reach maximum (peak) plasma drug concentration (time).
Pharmacokinetics Analysis Set (PAS) The PAS consists of all subjects who received at least one dose of EGF816 and have at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour (hr)
Cycle (C) 1 Day (D) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), C1D15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for Phase I part only) and C2D1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
Secondary
Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) of EGF816 and Metabolite LMI258 (Phase I & Phase II Part)
To characterize the PK properties of EGF816 and metabolite LMI258, AUCtau will be calculated (Phase I & II parts). AUCtau is the AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1).
Pharmacokinetics Analysis Set (PAS) The PAS consists of all subjects who received at least one dose of EGF816 and have at least one evaluable PK sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Cycle (C) 1 Day (D) 1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hours (hrs) post-dose), C1D15 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose) (for Phase I part only) and C2D1 (pre-dose and 0.5,1,2,3,4,6,8,12 and 24 hrs post-dose).
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
Secondary
Percentage Change From Baseline in H-score for Immunohistochemistry (IHC) Biomarkers From Tumor Tissue Samples (Phase I Part)
Changes in EGFR signaling pathway of newly obtained tumor samples following EGF816 treatment were evaluated by IHC of three pharmacodynamics (PD) biomarkers: p-EGFR, p-AKT and p-ERK. The assigned H-score semi-quantitatively assessed the expression level of these protein markers and their phosphorylated forms.
Pharmacokinetics Analysis Set (PAS) The PAS consists of all subjects who received at least one dose of EGF816 and have at least one evaluable PK sample.
Posted
Mean
Standard Deviation
percentage change
Baseline and Cycle 1 Day 15
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG002
EGF816 150 mg (Phase I Part)
Secondary
Overall Response Rate (ORR) by Investigator Assessment (Phase I & II Parts)
ORR is defined as percentage of patients with best overall response of partial response (PR)+ complete response (CR) determined by Investigator assessment in accordance to RECIST 1.1
Full Analysis Set (FAS) including participants who received at least one dose of EGF816 and who had a response.
Posted
Number
Percentage of participants
At least 24 weeks up to approx. 4 years
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
Secondary
Disease Control Rate (DCR) by Investigator Assessment (Phase I & II Parts)
DCR is defined as the proportion of patients with best overall response of CR, PR, or SD determined by Investigator assessment in accordance to RECIST 1.1
Full Analysis Set (FAS) including participants who received at least one dose of EGF816 and who had a response.
Posted
Number
Percentage of participants
At least 24 weeks up to approx. 4 years
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
Secondary
Time to Response (TTR) by Investigator Assessment (Phase I & II Parts)
TTR is defined as the time from the date of the first dose to the date of first documented response (CR or PR) determined by Investigator assessment in accordance to RECIST 1.1
Full Analysis Set (FAS) including participants who received at least one dose of EGF816 and who had a response.
Posted
Median
95% Confidence Interval
Months
At least 24 weeks up to approx. 9 years
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
Secondary
Number of Participants With Dose Interruptions and Dose Reductions (Phase I & II Parts)
Assessment of the tolerability of EGF816 will be performed continuously during the treatment phase
Safety Set: The Safety Set includes all subjects who received at least one dose of EGF816.
Posted
Count of Participants
Participants
At least 24 weeks up to approx. 9 years
ID
Title
Description
OG000
EGF816 75 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG001
EGF816 100 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
Secondary
Duration of Response (DOR) by BIRC (Phase II Part)
DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by BIRC in accordance to RECIST 1.1
Full Analysis Set (FAS) including participants who received at least one dose of EGF816 and who had a response.
Posted
Median
95% Confidence Interval
Months
At least 24 weeks up to approx. 9 years
ID
Title
Description
OG000
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG000
Secondary
Disease Control Rate (DCR) by BIRC (Phase II Part)
DCR is defined as the percentage of patients with best overall response of CR, PR, or SD determined by BIRC in accordance to RECIST 1.1
Full Analysis Set (FAS) including participants who received at least one dose of EGF816
Posted
Number
95% Confidence Interval
Percentage of participants
At least 24 weeks up to approx. 9 years
ID
Title
Description
OG000
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG000
Secondary
Progression-Free Survival (PFS) by BIRC (Phase II Part)
PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by BIRC in accordance to RECIST 1.1
Full Analysis Set (FAS) including participants who received at least one dose of EGF816
Posted
Median
95% Confidence Interval
months
At least 24 weeks up to approx. 9 years
ID
Title
Description
OG000
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG000
Secondary
Time to Response (TTR) by BIRC (Phase II Part)
TTR is defined as as the time from the date of first dose of study treatment to the date of first documented response (CR or PR) determined by by BIRC in accordance to RECIST 1.1
Full Analysis Set (FAS) including participants who received at least one dose of EGF816
Posted
Median
95% Confidence Interval
Months
At least 24 weeks up to approx. 9 years
ID
Title
Description
OG000
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG000
Secondary
Overall Survival (OS) (Phase II Part)
OS is defined as the time from first dose of the study treatment to the date of death due to any cause.
Full Analysis Set (FAS) including participants who received at least one dose of EGF816
Posted
Median
95% Confidence Interval
Months
At least 24 weeks up to approx. 9 years
ID
Title
Description
OG000
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG000
Time Frame
Adverse events (AEs) are collected from first dose of study treatment until end of study treatment plus 30 days post treatment. AEs reported in this record are from first dose of study treatment until 30 days after end of treatment, approx. 9 years.
Description
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
EGF816 75 mg (Phase l Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 75 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
3
17
7
17
17
17
EG001
EGF816 100 mg (Phase l Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 100 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
1
38
11
38
36
38
EG002
EGF816 150 mg (Phase l Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
13
73
40
73
73
73
EG003
EGF816 200 mg (Phase l Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
0
8
2
8
8
8
EG004
EGF8166 225 mg (Phase l Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
7
28
16
28
28
28
EG005
EGF816 300 mg (Phase l Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
0
5
4
5
5
5
EG006
EGF816 350 mg (Phase l Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
1
11
5
11
11
11
EG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
6
45
22
45
42
45
EG008
All Subjects
All subjects in the phase l and phase ll parts of the study.
31
225
107
225
220
225
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG0030 affected8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Haemorrhagic ascites
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Face oedema
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Fatigue
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pyrexia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Empyema
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hepatitis B reactivation
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Meningitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0020 affected73 at risk
EG003
Perihepatic abscess
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0014 affected38 at risk
EG0026 affected73 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Sepsis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Septic shock
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Suspected COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Viral infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Post procedural fever
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Hepatitis B DNA assay positive
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Follicular lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Lymphangiosis carcinomatosa
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Altered state of consciousness
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Seizure
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Device dislocation
Product Issues
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0023 affected73 at risk
EG003
Major depression
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Vaginal prolapse
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0024 affected73 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0015 affected38 at risk
EG00210 affected73 at risk
EG0030 affected8 at risk
EG0047 affected28 at risk
EG0053 affected5 at risk
EG0064 affected11 at risk
EG0075 affected45 at risk
EG00835 affected225 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0024 affected73 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0022 affected73 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0020 affected73 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Ear haemorrhage
Ear and labyrinth disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Dry eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0024 affected73 at risk
EG003
Eye discharge
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Vision blurred
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0025 affected73 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0023 affected73 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected17 at risk
EG0012 affected38 at risk
EG0024 affected73 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected17 at risk
EG00110 affected38 at risk
EG00217 affected73 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected17 at risk
EG00113 affected38 at risk
EG00229 affected73 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0025 affected73 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0025 affected73 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0013 affected38 at risk
EG0024 affected73 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected17 at risk
EG0018 affected38 at risk
EG00215 affected73 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0008 affected17 at risk
EG0019 affected38 at risk
EG00220 affected73 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0006 affected17 at risk
EG0016 affected38 at risk
EG00210 affected73 at risk
EG003
Asthenia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0025 affected73 at risk
EG003
Chest discomfort
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Chills
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0014 affected38 at risk
EG0022 affected73 at risk
EG003
Early satiety
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Fatigue
General disorders
MedDRA (26.0)
Systematic Assessment
EG0008 affected17 at risk
EG0018 affected38 at risk
EG00221 affected73 at risk
EG003
Gait disturbance
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Influenza like illness
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0023 affected73 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0012 affected38 at risk
EG00210 affected73 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0015 affected38 at risk
EG00211 affected73 at risk
EG003
Peripheral swelling
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Pyrexia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0013 affected38 at risk
EG0028 affected73 at risk
EG003
Swelling face
General disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Xerosis
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0020 affected73 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0013 affected38 at risk
EG0022 affected73 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Dermatitis infected
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Genital herpes
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Herpes zoster reactivation
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Influenza
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0002 affected17 at risk
EG0014 affected38 at risk
EG0025 affected73 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Paronychia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0013 affected38 at risk
EG00212 affected73 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0012 affected38 at risk
EG0022 affected73 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0024 affected73 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0023 affected73 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Skin infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0019 affected38 at risk
EG0027 affected73 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0002 affected17 at risk
EG0013 affected38 at risk
EG0024 affected73 at risk
EG003
Viral infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Wound infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0013 affected38 at risk
EG0020 affected73 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0024 affected73 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Vascular access site haematoma
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0002 affected17 at risk
EG0014 affected38 at risk
EG0024 affected73 at risk
EG003
Amylase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0002 affected17 at risk
EG0012 affected38 at risk
EG0025 affected73 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0021 affected73 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0021 affected73 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0012 affected38 at risk
EG0025 affected73 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0013 affected38 at risk
EG0021 affected73 at risk
EG003
Lipase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0012 affected38 at risk
EG0021 affected73 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Weight decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0012 affected38 at risk
EG0023 affected73 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0005 affected17 at risk
EG0014 affected38 at risk
EG00216 affected73 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0013 affected38 at risk
EG0021 affected73 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0022 affected73 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0013 affected38 at risk
EG0024 affected73 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0020 affected73 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0016 affected38 at risk
EG0029 affected73 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected17 at risk
EG0016 affected38 at risk
EG00211 affected73 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0023 affected73 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0016 affected38 at risk
EG00211 affected73 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0013 affected38 at risk
EG0021 affected73 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0017 affected38 at risk
EG0025 affected73 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0012 affected38 at risk
EG0026 affected73 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0026 affected73 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0016 affected38 at risk
EG0028 affected73 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0002 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0020 affected73 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Ataxia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Dementia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0005 affected17 at risk
EG0016 affected38 at risk
EG0029 affected73 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0017 affected38 at risk
EG00213 affected73 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0020 affected73 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Petit mal epilepsy
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Seizure
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Tremor
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0012 affected38 at risk
EG0021 affected73 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Depression
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected17 at risk
EG0012 affected38 at risk
EG0028 affected73 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0005 affected17 at risk
EG0017 affected38 at risk
EG00221 affected73 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0006 affected17 at risk
EG0011 affected38 at risk
EG00213 affected73 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0026 affected73 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected17 at risk
EG0010 affected38 at risk
EG0025 affected73 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0012 affected38 at risk
EG0022 affected73 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0023 affected73 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0028 affected73 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Cutaneous vasculitis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0022 affected73 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected17 at risk
EG0014 affected38 at risk
EG0028 affected73 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected17 at risk
EG0019 affected38 at risk
EG00215 affected73 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0013 affected38 at risk
EG0023 affected73 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected17 at risk
EG00111 affected38 at risk
EG00228 affected73 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected17 at risk
EG0014 affected38 at risk
EG0024 affected73 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0021 affected73 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0025 affected73 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0004 affected17 at risk
EG0019 affected38 at risk
EG00229 affected73 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0011 affected38 at risk
EG0022 affected73 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0011 affected38 at risk
EG0021 affected73 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0023 affected73 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0001 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Skin striae
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0003 affected17 at risk
EG0011 affected38 at risk
EG0025 affected73 at risk
EG003
Vasculitic rash
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Flushing
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hot flush
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 affected17 at risk
EG0010 affected38 at risk
EG0020 affected73 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0002 affected17 at risk
EG0014 affected38 at risk
EG0022 affected73 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
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG00012
OG00134
OG00268
OG0038
OG00424
OG0055
OG00611
OG00745
Title
Denominators
Categories
Title
Measurements
OG0006.3(1.54 to 47.80)
OG00112.1(7.16 to 16.56)
OG0027.4(5.32 to 9.59)
OG00313.7(3.52 to 27.47)
OG00411.1(7.23 to 23.49)
OG00511.8(5.62 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG00611.0(0.43 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG00718.2(11.04 to 30.16)
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG0005
OG00117
OG00234
OG0035
OG00415
OG0053
OG0064
OG00729
Title
Denominators
Categories
Title
Measurements
OG00046.2(3.68 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG00111.3(7.39 to 23.79)
OG0027.9(7.39 to 11.04)
OG00314.9(9.20 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG00416.5(5.52 to 29.63)
OG00510.2(9.33 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG00617.5(7.56 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG00720.3(11.01 to 34.89)
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG00017
OG00138
OG00272
OG0038
OG00428
OG0055
OG00611
OG00745
Title
Denominators
Categories
EFG816: Cycle (C) 1 Day (D) 1
ParticipantsOG00017
ParticipantsOG00136
ParticipantsOG00269
ParticipantsOG0038
ParticipantsOG00428
ParticipantsOG0055
ParticipantsOG00611
ParticipantsOG00745
Title
Measurements
OG000333± 64.9
OG001301± 81.8
OG002541± 53.2
OG003
EFG816: C1D15
ParticipantsOG00014
ParticipantsOG00136
ParticipantsOG00263
ParticipantsOG0037
EFG816: C2D1
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00259
ParticipantsOG0037
LMI258: C1D1
ParticipantsOG00017
ParticipantsOG00136
ParticipantsOG00268
ParticipantsOG0038
LMI258: C1D15
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00261
ParticipantsOG0037
LMI258: C2D1
ParticipantsOG00010
ParticipantsOG00130
ParticipantsOG00254
ParticipantsOG0036
OG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG00017
OG00138
OG00269
OG0038
OG00428
OG0055
OG00611
OG00743
Title
Denominators
Categories
EFG816: Cycle (C) 1 Day (D) 1
ParticipantsOG00017
ParticipantsOG00136
ParticipantsOG00269
ParticipantsOG0038
ParticipantsOG00428
ParticipantsOG0055
ParticipantsOG00611
ParticipantsOG00743
Title
Measurements
OG0002.83± 63.0
OG0013.24± 42.7
OG0022.74± 54.7
OG003
EFG816: C1D15
ParticipantsOG00014
ParticipantsOG00136
ParticipantsOG00263
ParticipantsOG0037
EFG816: C2D1
ParticipantsOG00012
ParticipantsOG00134
ParticipantsOG00259
ParticipantsOG0037
LMI258: C1D1
ParticipantsOG00017
ParticipantsOG00136
ParticipantsOG00268
ParticipantsOG0038
LMI258: C1D15
ParticipantsOG00013
ParticipantsOG00134
ParticipantsOG00261
ParticipantsOG0037
LMI258: C2D1
ParticipantsOG00010
ParticipantsOG00133
ParticipantsOG00257
ParticipantsOG0037
OG002
EGF816 150 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG00017
OG00138
OG00272
OG0038
OG00428
OG0055
OG00611
OG00745
Title
Denominators
Categories
EFG816: Cycle (C) 1 Day (D) 1
ParticipantsOG00016
ParticipantsOG00135
ParticipantsOG00266
ParticipantsOG0038
ParticipantsOG00426
ParticipantsOG0055
ParticipantsOG00611
ParticipantsOG00741
Title
Measurements
OG0004340± 68.2
OG0014000± 83.1
OG0026880± 53.3
OG003
EFG816: C1D15
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00257
ParticipantsOG0037
EFG816: C2D1
ParticipantsOG00012
ParticipantsOG00130
ParticipantsOG00256
ParticipantsOG0036
LMI258: C1D1
ParticipantsOG00015
ParticipantsOG00133
ParticipantsOG00265
ParticipantsOG0038
LMI258: C1D15
ParticipantsOG00013
ParticipantsOG00131
ParticipantsOG00257
ParticipantsOG0037
LMI258: C2D1
ParticipantsOG00010
ParticipantsOG00130
ParticipantsOG00254
ParticipantsOG0036
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG0002
OG0015
OG00210
OG0034
OG0049
OG0052
OG0064
OG0070
Title
Denominators
Categories
Pharmacodynamics (PD) parameter: P_AKT: % Change from baseline in H-Score
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG0034
ParticipantsOG0049
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0070
Title
Measurements
OG000-10.0± NANA = SD could not be calculated due to the low number of participants analyzed.
OG001-39.0± 78.2
OG002-31.8± 47.7
OG003
PD parameter: p-EGFR: % Change from baseline in H-Score
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG003
PD parameter: p-ERK: % Change from baseline in H-Score
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG00210
ParticipantsOG003
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG00012
OG00134
OG00268
OG0038
OG00424
OG0055
OG00611
OG00745
Title
Denominators
Categories
Title
Measurements
OG00041.7
OG00150.0
OG00250.0
OG00362.5
OG00462.5
OG00560.0
OG00636.4
OG00755.6
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG00012
OG00134
OG00268
OG0038
OG00424
OG0055
OG00611
OG00745
Title
Denominators
Categories
Title
Measurements
OG00083.3
OG00197.1
OG00283.3
OG003100.0
OG00495.8
OG005100.0
OG00672.7
OG00791.1
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG00012
OG00134
OG00268
OG0038
OG00424
OG0055
OG00611
OG00745
Title
Denominators
Categories
Title
Measurements
OG000NA(1.64 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG0015.5(1.81 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG00211.6(1.87 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG0034.5(1.64 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG0041.9(1.68 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG0051.7(1.61 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG006NA(1.64 to NA)NA = the upper limit of CI was not reached as there were not enough events observed
OG0071.9(1.84 to 7.16)
OG003
EGF816 200 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 200 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG004
EGF816 225 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 225 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG005
EGF816 300 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 300 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG006
EGF816 350 mg (Phase I Part)
Participants with locally advanced or metastatic NSCLC harboring specific EGFR mutations were administered with EGF816 350 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase I part of the study.
OG007
EGF816 150 mg (Phase II Part)
Treatment naïve participants with locally advanced or metastatic NSCLC harboring EGFR mutations were administered with 150 mg orally once a day as continuous daily dosing in each cycle (of 28 days) during Phase II part of the study.
Units
Counts
Participants
OG00017
OG00138
OG00273
OG0038
OG00428
OG0055
OG00611
OG00745
Title
Denominators
Categories
Participants with any dose Interruption
Title
Measurements
OG0003
OG00117
OG00235
OG0035
OG00420
OG0055
OG0066
OG00719
Participants with at least one dose reductions
Title
Measurements
OG0000
OG0011
OG0029
OG003
30
Title
Denominators
Categories
Title
Measurements
OG00018.6(14.88 to 31.41)
45
Title
Denominators
Categories
Title
Measurements
OG00093.3(81.70 to 98.60)
45
Title
Denominators
Categories
Title
Measurements
OG00018.9(14.75 to 29.44)
45
Title
Denominators
Categories
Title
Measurements
OG00048.3(22.93 to 58.84)
45
Title
Denominators
Categories
Title
Measurements
OG00048.3(22.93 to 58.84)
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0072 affected45 at risk
EG0086 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0072 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0072 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0042 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0084 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0044 affected28 at risk
EG0051 affected5 at risk
EG0063 affected11 at risk
EG0072 affected45 at risk
EG00821 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0084 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
2 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0071 affected45 at risk
EG0082 affected225 at risk
1 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0083 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0072 affected45 at risk
EG0084 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0085 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0042 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0083 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0084 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0084 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
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EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0085 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0084 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0072 affected45 at risk
EG0086 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0071 affected45 at risk
EG0085 affected225 at risk
3 affected
8 at risk
EG0042 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0075 affected45 at risk
EG00822 affected225 at risk
1 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0084 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0084 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
2 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0084 affected225 at risk
0 affected
8 at risk
EG0042 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
3 affected
8 at risk
EG00410 affected28 at risk
EG0052 affected5 at risk
EG0062 affected11 at risk
EG00714 affected45 at risk
EG00864 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0071 affected45 at risk
EG0084 affected225 at risk
0 affected
8 at risk
EG0048 affected28 at risk
EG0051 affected5 at risk
EG0061 affected11 at risk
EG0076 affected45 at risk
EG00836 affected225 at risk
1 affected
8 at risk
EG0042 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0072 affected45 at risk
EG0089 affected225 at risk
0 affected
8 at risk
EG0042 affected28 at risk
EG0052 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG00811 affected225 at risk
1 affected
8 at risk
EG0042 affected28 at risk
EG0051 affected5 at risk
EG0063 affected11 at risk
EG0071 affected45 at risk
EG00816 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0083 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0086 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0085 affected225 at risk
0 affected
8 at risk
EG0043 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0073 affected45 at risk
EG0089 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0042 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0083 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0072 affected45 at risk
EG0086 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0072 affected45 at risk
EG0088 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0083 affected225 at risk
1 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0084 affected225 at risk
2 affected
8 at risk
EG0046 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG00819 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0084 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0075 affected45 at risk
EG0089 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0084 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0045 affected28 at risk
EG0050 affected5 at risk
EG0063 affected11 at risk
EG00710 affected45 at risk
EG00834 affected225 at risk
1 affected
8 at risk
EG00411 affected28 at risk
EG0053 affected5 at risk
EG0065 affected11 at risk
EG0075 affected45 at risk
EG00852 affected225 at risk
2 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG00810 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0082 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0083 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
5 affected
8 at risk
EG00412 affected28 at risk
EG0053 affected5 at risk
EG0066 affected11 at risk
EG00713 affected45 at risk
EG00882 affected225 at risk
0 affected
8 at risk
EG0042 affected28 at risk
EG0051 affected5 at risk
EG0062 affected11 at risk
EG0078 affected45 at risk
EG00824 affected225 at risk
2 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0071 affected45 at risk
EG0085 affected225 at risk
0 affected
8 at risk
EG0044 affected28 at risk
EG0052 affected5 at risk
EG0060 affected11 at risk
EG0072 affected45 at risk
EG00815 affected225 at risk
4 affected
8 at risk
EG00415 affected28 at risk
EG0055 affected5 at risk
EG0066 affected11 at risk
EG00717 affected45 at risk
EG00889 affected225 at risk
1 affected
8 at risk
EG0043 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0088 affected225 at risk
0 affected
8 at risk
EG0041 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0083 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0071 affected45 at risk
EG0085 affected225 at risk
0 affected
8 at risk
EG0043 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0071 affected45 at risk
EG0088 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0044 affected28 at risk
EG0050 affected5 at risk
EG0062 affected11 at risk
EG0073 affected45 at risk
EG00819 affected225 at risk
1 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0051 affected5 at risk
EG0060 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
0 affected
8 at risk
EG0040 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0070 affected45 at risk
EG0081 affected225 at risk
1 affected
8 at risk
EG0042 affected28 at risk
EG0050 affected5 at risk
EG0061 affected11 at risk
EG0078 affected45 at risk
EG00820 affected225 at risk
641
± 60.2
OG004935± 66.1
OG0051070± 58.3
OG0061190± 50.0
OG007471± 41.2
Participants
OG004
21
ParticipantsOG0051
ParticipantsOG0066
ParticipantsOG0070
Title
Measurements
OG000402± 62.3
OG001477± 53.0
OG002765± 50.1
OG003939± 45.4
OG0041320± 46.0
OG0052670± NANA = Geo CV% could not be reached due to the low number of participants analyzed.
OG0061530± 23.5
Participants
OG004
20
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG00726
Title
Measurements
OG000348± 43.4
OG001426± 50.1
OG002767± 46.7
OG003938± 53.9
OG0041270± 61.0
OG0051700± 41.3
OG0061270± 30.4
OG007648± 50.9
Participants
OG004
28
ParticipantsOG0055
ParticipantsOG00611
ParticipantsOG00738
Title
Measurements
OG00014.1± 174.8
OG00111.4± 76.1
OG00225.2± 61.7
OG00330.9± 64.6
OG00442.0± 63.1
OG00562.2± 40.5
OG00652.7± 42.1
OG00724.3± 46.6
Participants
OG004
20
ParticipantsOG0051
ParticipantsOG0065
ParticipantsOG0070
Title
Measurements
OG00031.2± 94.7
OG00134.1± 81.8
OG00272.2± 64.0
OG003113± 54.1
OG004131± 56.8
OG005292± NANA = NA = Geo CV% could not be reached due to the low number of participants analyzed.
OG006164± 22.7
Participants
OG004
16
ParticipantsOG0053
ParticipantsOG0067
ParticipantsOG00713
Title
Measurements
OG00023.9± 59.5
OG00132.4± 76.0
OG00281.4± 55.4
OG003114± 75.1
OG004101± 72.8
OG005142± 55.1
OG006116± 68.7
OG00762.5± 60.7
3.66
± 74.1
OG0042.64± 64.9
OG0053.37± 41.0
OG0063.45± 22.4
OG0072.81± 43.4
Participants
OG004
21
ParticipantsOG0051
ParticipantsOG0066
ParticipantsOG0070
Title
Measurements
OG0002.91± 57.7
OG0012.75± 75.8
OG0023.11± 46.4
OG0033.52± 44.3
OG0043.46± 36.1
OG0056.08± NANA = Geo CV% could not be reached due to the low number of participants analyzed.
OG0064.45± 35.4
Participants
OG004
20
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG00726
Title
Measurements
OG0003.13± 44.7
OG0012.81± 49.0
OG0023.14± 54.0
OG0033.53± 35.3
OG0043.17± 38.2
OG0052.99± 0.6
OG0063.97± 44.1
OG0073.48± 52.7
Participants
OG004
28
ParticipantsOG0055
ParticipantsOG00611
ParticipantsOG00738
Title
Measurements
OG0002.54± 65.7
OG0013.14± 43.6
OG0022.78± 65.2
OG0033.19± 73.6
OG0042.99± 71.4
OG0053.37± 41.5
OG0063.53± 31.8
OG0072.70± 43.3
Participants
OG004
20
ParticipantsOG0051
ParticipantsOG0065
ParticipantsOG0070
Title
Measurements
OG0002.89± 55.1
OG0012.76± 63.8
OG0023.32± 54.7
OG0034.05± 32.6
OG0044.03± 38.7
OG0057.12± NANA = Geo CV% could not be reached due to the low number of participants analyzed.
OG0064.54± 39.3
Participants
OG004
19
ParticipantsOG0053
ParticipantsOG0068
ParticipantsOG00713
Title
Measurements
OG0003.38± 64.7
OG0013.04± 57.6
OG0023.43± 55.0
OG0035.00± 56.1
OG0043.26± 46.6
OG0053.77± 42.4
OG0064.13± 47.8
OG0073.92± 45.5
8310
± 51.2
OG00412100± 64.7
OG00515000± 61.0
OG00616900± 51.0
OG0075720± 42.7
Participants
OG004
18
ParticipantsOG0051
ParticipantsOG0065
ParticipantsOG0070
Title
Measurements
OG0006370± 61.1
OG0016770± 66.0
OG00211300± 53.2
OG00313500± 44.1
OG00420300± 54.6
OG00551200± NANA = Geo CV% could not be reached due to the low number of participants analyzed.
OG00625700± 26.1
Participants
OG004
17
ParticipantsOG0053
ParticipantsOG0067
ParticipantsOG00725
Title
Measurements
OG0005670± 44.7
OG0016150± 58.6
OG00211800± 50.3
OG00315800± 10.6
OG00418600± 66.5
OG00526100± 53.0
OG00622300± 19.0
OG0079830± 51.3
Participants
OG004
26
ParticipantsOG0055
ParticipantsOG00611
ParticipantsOG00737
Title
Measurements
OG000182± 56.8
OG001162± 78.0
OG002330± 62.1
OG003424± 56.0
OG004559± 62.4
OG005859± 50.0
OG006810± 47.0
OG007291± 45.3
Participants
OG004
19
ParticipantsOG0051
ParticipantsOG0065
ParticipantsOG0070
Title
Measurements
OG000466± 82.1
OG001523± 111.1
OG0021170± 69.5
OG0031810± 58.6
OG0042460± 65.2
OG0055940± NANA = Geo CV% could not be reached due to the low number of participants analyzed.
OG0063420± 45.6
Participants
OG004
16
ParticipantsOG0053
ParticipantsOG0067
ParticipantsOG00713
Title
Measurements
OG000402± 65.7
OG001499± 97.7
OG0021380± 58.6
OG0032340± 45.2
OG0041760± 90.3
OG0052360± 65.9
OG0062820± 34.8
OG0071060± 67.7
3.5
± 14.5
OG00416.1± 65.3
OG005-2.5± 3.5
OG006-51.3± 71.9
4
ParticipantsOG0049
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0070
Title
Measurements
OG000-165.0± NANA = SD could not be calculated due to the low number of participants analyzed.
OG001-21.8± 43.9
OG002-19.5± 34.7
OG003-38.8± 50.1
OG0042.2± 23.7
OG005-32.5± 38.9
OG006-12.5± 18.9
4
ParticipantsOG0048
ParticipantsOG0052
ParticipantsOG0064
ParticipantsOG0070
Title
Measurements
OG000-60.0± NANA = SD could not be calculated due to the low number of participants analyzed.