Trial of MSC1936369B in Subjects With Solid Tumors | NCT00982865 | Trialant
NCT00982865
Sponsor
Merck KGaA, Darmstadt, Germany
Status
Completed
Last Update Posted
Oct 23, 2018Actual
Enrollment
182Actual
Phase
Phase 1
Conditions
Solid Tumors
Cancer
Interventions
MSC1936369B
MSC1936369B
MSC1936369B
MSC1936369B
Countries
Australia
Belgium
France
Netherlands
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00982865
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
28062
Secondary IDs
ID
Type
Description
Link
2007-004665-18
EudraCT Number
Brief Title
Trial of MSC1936369B in Subjects With Solid Tumors
Official Title
A Multicenter, Open Label, Phase I Trial of the MEK Inhibitor MSC1936369B Given Orally to Subjects With Solid Tumours
Acronym
Not provided
Organization
Merck KGaA, Darmstadt, GermanyINDUSTRY
Status Module
Record Verification Date
Feb 2018
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
Dec 31, 2007Actual
Primary Completion Date
Mar 31, 2013Actual
Completion Date
Apr 30, 2016Actual
First Submitted Date
Sep 22, 2009
First Submission Date that Met QC Criteria
Sep 22, 2009
First Posted Date
Sep 23, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 14, 2017
Results First Submitted that Met QC Criteria
Feb 9, 2018
Results First Posted Date
Oct 23, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 9, 2018
Last Update Posted Date
Oct 23, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck KGaA, Darmstadt, GermanyINDUSTRY
Collaborators
Name
Class
Merck Serono S.A., Geneva
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a first in man trial with a primary objective being the determination of the Maximum Tolerated dose (MTD) and the dose-limiting toxicity (DLT) in several regimens of MEK inhibitor MSC1936369B administered orally once a day, in subjects with malignant solid tumors to see how safe is treatment with MSC1936369B.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Cancer
Keywords
MEK inhibitor
Cancer
Solid tumors
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
182Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MSC1936369B Regimen 1
Experimental
Subjects will be administered MSC1936369B (pimasertib) capsules 1 to 120 milligram (mg) orally, once daily (QD) on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until progressive disease (PD) or intolerable toxicity or investigator/subject decision.
Drug: MSC1936369B
MSC1936369B Regimen 2
Experimental
MSC1936369B Regimen 2 (Without Food Effect): Subjects will be administered MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
MSC1936369B Regimen 2 (With Food Effect): : Subjects will be administered MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
Drug: MSC1936369B
MSC1936369B Regimen 3 once daily
Experimental
Subjects will be administered MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Drug: MSC1936369B
MSC1936369B Regimen 3 twice daily (BID)
Experimental
Subjects will be administered MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MSC1936369B
Drug
MSC1936369B Regimen 1
Pimasertib
MSC1936369B
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21
DLT was defined as any of following toxicities at any dose level according to using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) v3.0(CTCAE), probably or possibly related to trial medication by investigator or sponsor: a)Any Grade 3 or more non-haematological toxicity excluding: (i)Grade 3 asymptomatic increase in liver function tests (Aspartate Aminotransferase, Alanine transaminase, Alkaline Phosphatase reversible within 7 days for subjects without liver involvement, or grade 4 for subjects with liver involvement; (ii)Grade 3 vomiting if it is encountered despite adequate and optimal therapy (e.g. serotonin [5HT3] antagonists and corticosteroids); (iii)Grade 3 diarrhoea if it is encountered despite adequate and optimal anti diarrhoea therapy; b)Grade 4 neutropenia of >5 days duration or febrile neutropenia lasting for more than 1 day; c)Grade 4 thrombocytopenia >1 day or grade 3 with bleeding; d)Any treatment delay >2 weeks due to drug-related AEs.
Day 1 up to Day 21 of Cycle 1
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation
AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 253 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Pathologically-confirmed solid tumor which is locally advanced or metastatic, and either refractory after standard therapy for the disease or for which no effective standard therapy is available. In the regimen 3, regimen 2 food-effect, and BID cohorts, the tumor type will be restricted to melanoma.
Age greater than or equal to (>=) 18 years
Has read and understands the informed consent form and is willing and able to give informed consent. Fully understands requirements of the trial and willing to comply with all trial visits and assessments
Exclusion Criteria:
Bone marrow impairment as evidenced by Haemoglobin less than (<) 9.0 gram per deciliter (g/dL), Neutrophil count < 1.0*10^9/Liter, platelets < 100*10^9/Liter
Renal impairment as evidenced by serum creatinine > 1.5*upper limit normal (ULN), and/or calculated creatinine clearance < 60 milliliter per minute (mL/min)
Liver function abnormality as defined by total bilirubin > 1.5*ULN, or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5*ULN, for subjects with liver involvement AST/ALT > 5*ULN
INR > 1.5*ULN
Serum calcium > 1*ULN
History of central nervous system (CNS) metastases, unless subject has been previously treated for CNS metastases, is stable by computer tomography (CT) scan without evidence of cerebral oedema, and has no requirements for corticosteroids or anticonvulsants
History of difficulty swallowing, malabsorption or other chronic gastro-intestinal disease or conditions that may hamper compliance and/or absorption of the tested product
Eastern Cooperative Oncology Group Performance status (ECOG PS) greater than (>) 1
Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B
A total of 182 subjects entered the trial, of which 2 did not receive any treatment. 180 subjects received the study treatment and were included in the subject disposition table.
Recruitment Details
First/last subject (informed consent): December 2007/March 2012. Last subject completed: April 2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
FG001
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
FG002
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
FG003
MSC1936369B Regimen 3 Twice Daily (BID)
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00049 subjects
FG00182 subjects
FG00215 subjects
FG00334 subjects
COMPLETED
FG00049 subjects
FG00182 subjects
FG00215 subjects
FG00334 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Safety analysis set included all subjects who received at least 1 dose of MSC1936369B treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
BG001
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21
DLT was defined as any of following toxicities at any dose level according to using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) v3.0(CTCAE), probably or possibly related to trial medication by investigator or sponsor: a)Any Grade 3 or more non-haematological toxicity excluding: (i)Grade 3 asymptomatic increase in liver function tests (Aspartate Aminotransferase, Alanine transaminase, Alkaline Phosphatase reversible within 7 days for subjects without liver involvement, or grade 4 for subjects with liver involvement; (ii)Grade 3 vomiting if it is encountered despite adequate and optimal therapy (e.g. serotonin [5HT3] antagonists and corticosteroids); (iii)Grade 3 diarrhoea if it is encountered despite adequate and optimal anti diarrhoea therapy; b)Grade 4 neutropenia of >5 days duration or febrile neutropenia lasting for more than 1 day; c)Grade 4 thrombocytopenia >1 day or grade 3 with bleeding; d)Any treatment delay >2 weeks due to drug-related AEs.
Dose Escalation Analysis Set included all subjects who meet at least 1 of following criteria:
subjects who experienced any DLT during Cycle 1 & who received planned treatment.
Posted
Number
Subjects
Day 1 up to Day 21 of Cycle 1
Adverse Events Module
Frequency Threshold
0
Time Frame
Baseline up to 253 weeks
Description
The safety analysis set (SAF) included all subjects who received at least 1 administration of MSC1936369B.
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
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Death
Baseline up to 253 weeks
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Any clinically significant changes in laboratory evaluations and vital signs were recorded as treatment emergent adverse events. The clinical laboratory parameters that were assessed included: Hematological parameters, Blood chemistry parameters, Urinalysis and the vital signs that were assessed included: Blood pressure, Heart rate, Temperature and Weight. SAF analysis was used.
Baseline up to 253 weeks
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 1
Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours (h) post-dose on Cycle 1(C1) Day 1 (D1), Cycle 1 Day 12 (D12) and Cycle 3 (C3) Day 1
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (Without Food Effect)
Cmax was obtained directly from the concentration versus time curve.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (With Food Effect)
Cmax was obtained directly from the concentration versus time curve. Summarized data over Day 1 and Day 2 was reported.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Once Daily
Cmax was obtained directly from the concentration versus time curve.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Twice Daily
Cmax was obtained directly from the concentration versus time curve.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 1
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (Without Food Effect)
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (With Food Effect)
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. Summarized data over Day 1 and Day 2 was reported.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Once Daily
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Twice Daily
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 1
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: : Regimen 2 (Without Food Effect)
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 2 (With Food Effect)
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Summarized data over Day 1 and Day 2 was reported.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Once Daily
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Twice Daily
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B : Regimen 1
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (Without Food Effect)
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (With Food Effect)
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. Summarized data over Day 1 and Day 2 was reported.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Twice Daily
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Once Daily
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 1
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. As AUCextra was >20% of AUC0-inf, t1/2 derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. As AUCextra was >20% of AUC0-inf, t1/2 derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. Summarized data over Day 1 and Day 2 was reported.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Once Daily
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Twice Daily
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 1
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. As AUCextra was >20% of AUC0-inf, CL/f derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (Without Food Effect)
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. As AUCextra was >20% of AUC0-inf, CL/f derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (With Food Effect)
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. Summarized data over Day 1 and Day 2 was reported.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Once Daily
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Twice Daily
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
Apparent Volume of Distribution Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 1
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. As AUCextra was >20% of AUC0-inf, Vz/F derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (Without Food Effect)
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. As AUCextra was >20% of AUC0-inf, Vz/F derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (With Food Effect)
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. Summarized data over Day 1 and Day 2 was reported.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Once Daily
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Twice Daily
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 1
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- [AUC0-t / AUC0-inf])*100. %AUCextra was reported in terms of percentage of AUC0-inf.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (Without Food Effect)
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- [AUC0-t / AUC0-inf])*100. %AUCextra was reported in terms of percentage of AUC0-inf.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (With Food Effect)
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- [AUC0-t / AUC0-inf])*100. AUCextra was reported in terms of percentage of AUC0-inf. Summarized data over Day 1 and Day 2 was reported.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Once Daily
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- [AUC0-t / AUC0-inf])*100. AUCextra was reported in terms of percentage of AUC0-inf.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Twice Daily
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- [AUC0-t / AUC0-inf])*100. AUCextra was reported in terms of percentage of AUC0-inf.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
Pre-dose on C1D1, C1D2, C1D5, C1D8; 2, 4, 8 h post-dose on C1D1; pre-dose, 2, 8, 24 h post-dose on C1D12-15; pre-dose, 2, 4 h post-dose on C1D3
Number of Subjects With Clinical Benefit (Complete Response [CR], Partial Response [PR] or Stable Disease [SD}) and Progressive Disease (PD) Based on the Best Overall Response (BOR)
Number of subjects with clinical benefit (CR, PR, or SD) and PD according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.
Baseline until disease progression (assessed up to end of treatment [253 weeks])
Brussels
B-1000
Belgium
Ghent University Hospital
Ghent
Belgium
Institute Bergonié
Bordeaux
France
Hôpital Beaujon
Paris
92118
France
Hopital Saint Louis
Paris
France
Centre Eugène Marquis
Rennes
France
Institute Claudius Regaud
Toulouse
03 31052
France
Netherlands Cancer Institute - Antonie van Leeuwenhoek Hospital
Amsterdam
Netherlands
Derived
Delord JP, Italiano A, Awada A, Aftimos P, Houede N, Lebbe C, Pages C, Lesimple T, Dinulescu M, Schellens JHM, Leijen S, Rottey S, Kruse V, Kefford R, Faivre S, Gomez-Roca C, Scheuler A, Massimini G, Raymond E. Selective Oral MEK1/2 Inhibitor Pimasertib: A Phase I Trial in Patients with Advanced Solid Tumors. Target Oncol. 2021 Jan;16(1):37-46. doi: 10.1007/s11523-020-00768-0.
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
BG002
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
BG003
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
BG004
Total
Total of all reporting groups
49
BG00182
BG00215
BG00334
BG004180
Participants
Title
Denominators
Categories
>= 18 - <45 Years
Title
Measurements
BG0004
BG00110
BG0024
BG0037
BG00425
>=45 - <65 Years
Title
Measurements
BG00030
BG00149
BG0029
BG003
>=65 Years
Title
Measurements
BG00015
BG00123
BG0022
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00130
BG0029
BG00311
BG00470
Male
BG00029
BG00152
BG0026
BG00323
BG004
ID
Title
Description
OG000
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
OG002
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG00044
OG00174
OG00215
OG00333
Title
Denominators
Categories
Title
Measurements
OG0002
OG0016
OG0020
OG0036
Secondary
Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation
AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 253 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.
Safety Analysis Set (SAF) included all subjects who received at least 1 dose of MSC1936369B treatment.
Posted
Number
Subjects
Baseline up to 253 weeks
ID
Title
Description
OG000
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
OG002
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG00049
OG00182
OG00215
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00047
OG00182
OG00215
OG003
Secondary
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Death
ALL subject analysis set was used which included all the subjects who signed the informed consent form and entered the study.
Posted
Number
Subjects
Baseline up to 253 weeks
ID
Title
Description
OG000
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
OG002
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG00049
OG00183
OG00215
OG003
Title
Denominators
Categories
Title
Measurements
OG00010
OG00114
OG0022
OG003
Secondary
Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events
Any clinically significant changes in laboratory evaluations and vital signs were recorded as treatment emergent adverse events. The clinical laboratory parameters that were assessed included: Hematological parameters, Blood chemistry parameters, Urinalysis and the vital signs that were assessed included: Blood pressure, Heart rate, Temperature and Weight. SAF analysis was used.
SAF analysis was used.
Posted
Number
Subjects
Baseline up to 253 weeks
ID
Title
Description
OG000
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
OG002
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG00049
OG00182
OG00215
OG003
Title
Denominators
Categories
Haemoglobin decreased
Title
Measurements
OG0001
OG0012
OG0020
OG003
Secondary
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 1
Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.
PK analysis set: subjects received at least 1 dose of drug & provided sufficient PK serum samples for at least 1st 24h following 1st dose of C1D1. Number of Participants Analyzed=subjects evaluable for this endpoint & Number analyzed=subjects evaluated at specified time point & "0"indicates no subject analyzed for that specific time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours (h) post-dose on Cycle 1(C1) Day 1 (D1), Cycle 1 Day 12 (D12) and Cycle 3 (C3) Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 1.5 mg
Subjects received 1.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 2.5 mg
Subjects received 2.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (Without Food Effect)
Cmax was obtained directly from the concentration versus time curve.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 2 mg
Subjects received 2 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 5 mg
Subjects received 5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG011
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG012
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG013
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (With Food Effect)
Cmax was obtained directly from the concentration versus time curve. Summarized data over Day 1 and Day 2 was reported.
The food effect analysis set included all subjects who fulfilled following conditions: Food & drink intake, trial medication administration according to protocol, & not excreted irregularly, PK samples collected. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this endpoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
ID
Title
Description
OG000
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0008
OG0011
Title
Denominators
Categories
Fasted
Title
Measurements
OG000321.14± 58.3
OG0011158.00± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
Fed
Title
Measurements
OG000
Secondary
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Once Daily
Cmax was obtained directly from the concentration versus time curve.
PKS analysis set. Here "Number Analyzed" signifies the subjects who were evaluated at that specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00112
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG000241.27± 47.0
Secondary
Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Twice Daily
Cmax was obtained directly from the concentration versus time curve.
PKS analysis set. Here "Number analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 75 mg
Subjects received 75 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00118
OG00213
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00118
ParticipantsOG00213
Title
Measurements
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 1
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.
Posted
Median
Full Range
Hours (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 1.5 mg
Subjects received 1.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 2.5 mg
Subjects received 2.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (Without Food Effect)
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.
Posted
Median
Full Range
Hours (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 2 mg
Subjects received 2 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 5 mg
Subjects received 5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG011
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG012
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG013
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 2 (With Food Effect)
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. Summarized data over Day 1 and Day 2 was reported.
The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Posted
Median
Full Range
Hours (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
ID
Title
Description
OG000
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0008
OG0011
Title
Denominators
Categories
Fasted
Title
Measurements
OG0001.600(0.33 to 2.50)
OG0011.000(1.00 to 1.00)
Fed
Title
Measurements
OG000
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Once Daily
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Median
Full Range
Hours (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00112
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0001.033(1.00 to 1.50)
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 3 Twice Daily
Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Median
Full Range
Hours (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 75 mg
Subjects received 75 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00118
OG00213
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00118
ParticipantsOG00213
Title
Measurements
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 1
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*nanogram per milliliter (h*ng/mL)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 1.5 mg
Subjects received 1.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 2.5 mg
Subjects received 2.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: : Regimen 2 (Without Food Effect)
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number Analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 2 mg
Subjects received 2 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 5 mg
Subjects received 5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG011
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG012
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG013
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 2 (With Food Effect)
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Summarized data over Day 1 and Day 2 was reported.
The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
ID
Title
Description
OG000
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0008
OG0011
Title
Denominators
Categories
Fasted
Title
Measurements
OG0001509.6± 46.6
OG0013286± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
Fed
Title
Measurements
OG000
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Once Daily
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
PKS analysis set. Here "Number analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00112
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0001229.3± 96.5
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of MSC1936369B: Regimen 3 Twice Daily
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 75 mg
Subjects received 75 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00118
OG00213
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00118
ParticipantsOG00213
Title
Measurements
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B : Regimen 1
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 1.5 mg
Subjects received 1.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 2.5 mg
Subjects received 2.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (Without Food Effect)
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 2 mg
Subjects received 2 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 5 mg
Subjects received 5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG011
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG012
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG013
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0002
OG0013
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG003
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 2 (With Food Effect)
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. Summarized data over Day 1 and Day 2 was reported.
The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
ID
Title
Description
OG000
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0008
OG0011
Title
Denominators
Categories
Fasted
Title
Measurements
OG0001580.6± 48.7
OG0013344.3± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
Fed
Title
Measurements
OG000
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Twice Daily
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 75 mg
Subjects received 75 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00118
OG00213
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00117
ParticipantsOG00213
Title
Measurements
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MSC1936369B: Regimen 3 Once Daily
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00112
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0001253.1± 96.9
Secondary
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 1
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. As AUCextra was >20% of AUC0-inf, t1/2 derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 1.5 mg
Subjects received 1.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 2.5 mg
Subjects received 2.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. As AUCextra was >20% of AUC0-inf, t1/2 derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 2 mg
Subjects received 2 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 5 mg
Subjects received 5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG011
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG012
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG013
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. Summarized data over Day 1 and Day 2 was reported.
The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
ID
Title
Description
OG000
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0008
OG0011
Title
Denominators
Categories
Fasted
Title
Measurements
OG0004.898± 36.7
OG0014.452± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
Fed
Title
Measurements
OG000
Secondary
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Once Daily
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00112
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0004.236± 1.3
Secondary
Apparent Terminal Half-life (t1/2) of MSC1936369B: Regimen 3 Twice Daily
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour (h)
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 75 mg
Subjects received 75 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00117
OG00212
Title
Denominators
Categories
C1D1
ParticipantsOG0001
ParticipantsOG00117
ParticipantsOG00212
Title
Measurements
Secondary
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 1
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. As AUCextra was >20% of AUC0-inf, CL/f derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 1.5 mg
Subjects received 1.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 2.5 mg
Subjects received 2.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (Without Food Effect)
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. As AUCextra was >20% of AUC0-inf, CL/f derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 2 mg
Subjects received 2 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 5 mg
Subjects received 5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG011
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG012
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG013
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 2 (With Food Effect)
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. Summarized data over Day 1 and Day 2 was reported.
The food effect analysis set (FES). Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
ID
Title
Description
OG000
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0008
OG0011
Title
Denominators
Categories
Fasted
Title
Measurements
OG00056.94± 48.7
OG00144.85± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
Fed
Title
Measurements
OG000
Secondary
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Once Daily
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf.
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00112
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG00047.88± 96.9
Secondary
Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of MSC1936369B: Regimen 3 Twice Daily
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter per hour
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 75 mg
Subjects received 75 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00117
OG00212
Title
Denominators
Categories
C1D1
ParticipantsOG0001
ParticipantsOG00117
ParticipantsOG00212
Title
Measurements
Secondary
Apparent Volume of Distribution Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 1
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. As AUCextra was >20% of AUC0-inf, Vz/F derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 1.5mg, 2.5 mg.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 1.5 mg
Subjects received 1.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 2.5 mg
Subjects received 2.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (Without Food Effect)
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. As AUCextra was >20% of AUC0-inf, Vz/F derived from λz was regarded as implausible & not calculated for arms MSC1936369B 1mg, 2mg, 3.5 mg.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 2 mg
Subjects received 2 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 5 mg
Subjects received 5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG011
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG012
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG013
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Secondary
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 2 (With Food Effect)
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. Summarized data over Day 1 and Day 2 was reported.
The food effect analysis set (FES). Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome Measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
ID
Title
Description
OG000
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0008
OG0011
Title
Denominators
Categories
Fasted
Title
Measurements
OG000402.4± 49.0
OG001288.1± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
Fed
Title
Measurements
OG000
Secondary
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Once Daily
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00112
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG000292.61± 99.0
Secondary
Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of MSC1936369B: Regimen 3 Twice Daily
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 75 mg
Subjects received 75 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00117
OG00212
Title
Denominators
Categories
C1D1
ParticipantsOG0001
ParticipantsOG00117
ParticipantsOG00212
Title
Measurements
Secondary
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 1
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- [AUC0-t / AUC0-inf])*100. %AUCextra was reported in terms of percentage of AUC0-inf.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Percentage of AUC 0-∞
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 1.5 mg
Subjects received 1.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 2.5 mg
Subjects received 2.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0002
OG0011
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG003
Secondary
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (Without Food Effect)
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- [AUC0-t / AUC0-inf])*100. %AUCextra was reported in terms of percentage of AUC0-inf.
PKS analysis set. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure and "Number Analyzed" signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Percentage of AUC 0-∞
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 1 mg
Subjects received 1 mg of MSC1936369B (capsule formulation) orally, once daily on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 2 mg
Subjects received 2 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 3.5 mg
Subjects received 3.5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B 5 mg
Subjects received 5 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG004
MSC1936369B 7 mg
Subjects received 7 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG005
MSC1936369B 14 mg
Subjects received 14 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG006
MSC1936369B 28 mg
Subjects received 28 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG007
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG008
MSC1936369B 68 mg
Subjects received 68 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG009
MSC1936369B 94 mg
Subjects received 94 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG010
MSC1936369B 120 mg
Subjects received 120 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG011
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG012
MSC1936369B 195 mg
Subjects received 195 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG013
MSC1936369B 255 mg
Subjects received 255 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0002
OG0013
OG0023
OG003
Title
Denominators
Categories
C1D1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0022
ParticipantsOG003
Secondary
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 2 (With Food Effect)
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- [AUC0-t / AUC0-inf])*100. AUCextra was reported in terms of percentage of AUC0-inf. Summarized data over Day 1 and Day 2 was reported.
The food effect analysis set (FES). Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome Measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Percentage of AUC 0-∞
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2
ID
Title
Description
OG000
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 150 mg
Subjects received 150 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0008
OG0011
Title
Denominators
Categories
Fasted
Title
Measurements
OG0002.54± 149.8
OG0011.74± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
Fed
Title
Measurements
OG000
Secondary
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Once Daily
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- [AUC0-t / AUC0-inf])*100. AUCextra was reported in terms of percentage of AUC0-inf.
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
percentage of AUC 0-∞
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 90 mg
Subjects received 90 mg of MSC1936369B (capsule formulation) orally, QD on Days 1 and Day 2 of 21-day treatment cycle in either fed or fasted state until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00112
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0001.88± 16.2
Secondary
Area Under the Concentration Time Curve Extrapolated From Last Observation to Infinity Given as Percentage of AUC 0-∞ (AUC Extra): Regimen 3 Twice Daily
AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: AUCextra = (1- [AUC0-t / AUC0-inf])*100. AUCextra was reported in terms of percentage of AUC0-inf.
PKS analysis set. Here "Number Analyzed" signifies those who were evaluated at the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
Percentage of AUC 0-∞
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1
ID
Title
Description
OG000
MSC1936369B 45 mg
Subjects received 45 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B 60 mg
Subjects received 60 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG002
MSC1936369B 75 mg
Subjects received 75 mg of MSC1936369B (capsule formulation) orally, BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG0003
OG00118
OG00213
Title
Denominators
Categories
C1D1
ParticipantsOG0003
ParticipantsOG00117
ParticipantsOG00213
Title
Measurements
Secondary
Phosphorylated Extra-Cellular Signal-Regulated Kinase (pERK) Fold Change in Peripheral Blood Monocyte Cells (PBMC) and Tot ERK Fold Change in Peripheral Blood Monocyte Cells (PBMC)
Analysis population included subjects from safety analysis set having at least one pERK/tot ERK sample and not excluded from the analysis as per SAP. Number analyzed= subjects who were evaluated at the specified time point. Data was not available for categories with Number analyzed=0 because there was no subject analyzed at specified time point.
Posted
Mean
Standard Deviation
fold change
Pre-dose on C1D1, C1D2, C1D5, C1D8; 2, 4, 8 h post-dose on C1D1; pre-dose, 2, 8, 24 h post-dose on C1D12-15; pre-dose, 2, 4 h post-dose on C1D3
ID
Title
Description
OG000
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
OG002
MSC1936369B Regimen 3 Once Daily
Subjects received MSC1936369B capsules 60 or 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG00041
OG00176
OG00212
OG003
Title
Denominators
Categories
C1D1, Pre-dose (pERK)
ParticipantsOG00041
ParticipantsOG00176
ParticipantsOG00212
ParticipantsOG003
Secondary
Number of Subjects With Clinical Benefit (Complete Response [CR], Partial Response [PR] or Stable Disease [SD}) and Progressive Disease (PD) Based on the Best Overall Response (BOR)
Number of subjects with clinical benefit (CR, PR, or SD) and PD according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.
The SAF included all subjects who received at least 1 administration of MSC1936369B. Here "Number of Subjects analysed" = subjects evaluable for this endpoint.
Posted
Number
Subjects
Baseline until disease progression (assessed up to end of treatment [253 weeks])
ID
Title
Description
OG000
MSC1936369B Regimen 1
Subjects received MSC1936369B capsules 1 to 120 mg orally, QD on Days 1 to 5, 8 to 12, 15 to 19 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG001
MSC1936369B Regimen 2 and Regimen 2 Food Effect
Combined data for both Regimen 2 with and without food effect was reported in this arm. MSC1936369B Regimen 2: Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (FE): Subjects received MSC1936369B capsules 90-150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Cycle 2 dosing.
OG002
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
OG003
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
Units
Counts
Participants
OG00039
OG00171
OG00215
OG003
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
OG0020
OG003
23
49
47
49
EG001
MSC1936369B Regimen 2 (Without Food Effect + With Food Effect)
MSC1936369B Regimen 2 (Without Food Effect): Subjects received MSC1936369B capsules 1 to 255 mg orally QD on Days 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. MSC1936369B Regimen 2 (With Food Effect): Subjects received MSC1936369B capsules 90 or 150 mg orally QD on Day 1 to 15 of each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision. Subjects in the Regimen 2 FE cohort were assigned in a 1:1 ratio to either the fed/fasted sequence or fasted/fed sequence for Day 1 of Cycle 1 and Day 1 of Cycle 2.
45
82
80
82
EG002
MSC1936369B Regimen 3 Once Daily (QD)
Subjects received MSC1936369B capsules 60 to 90 mg orally QD in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
8
15
15
15
EG003
MSC1936369B Regimen 3 Twice Daily
Subjects received MSC1936369B capsules 45 to 75 mg orally BID in each 21-day treatment cycle until PD or intolerable toxicity or investigator/subject decision.
21
34
34
34
EG0007 affected49 at risk
EG00113 affected82 at risk
EG0022 affected15 at risk
EG0032 affected34 at risk
Pyrexia
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0013 affected82 at risk
EG0021 affected15 at risk
EG0032 affected34 at risk
Asthenia
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Chest pain
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hyperthermia
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0014 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Disease progression
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Fatigue
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Obstruction
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Oedema peripheral
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Device occlusion
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Malaise
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Mucosal inflammation
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Retinal detachment
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Choroiditis
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Macular degeneration
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Retinal vein occlusion
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Retinal vein thrombosis
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Visual acuity reduced
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Visual impairment
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Macular oedema
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Retinal haemorrhage
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Vision blurred
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Retinal artery occlusion
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Atrial flutter
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Tachycardia
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Bradycardia
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Conduction disorder
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Sinus bradycardia
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Haematemesis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Subileus
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0022 affected15 at risk
EG0034 affected34 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Ascites
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Constipation
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Nausea
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0022 affected15 at risk
EG0031 affected34 at risk
Hepatic failure
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hepatotoxicity
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Erysipelas
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Sepsis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Septic shock
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Cellulitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Staphylococcal sepsis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Urinary tract infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Erysipelas
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Pelvic infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0014 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Alveolitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Leukoencephalopathy
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Coordination abnormal
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Headache
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0022 affected15 at risk
EG0031 affected34 at risk
Intracranial pressure increased
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Neurological decompensation
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Seizure
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Presyncope
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Spinal cord compression
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Hepatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Bronchial neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Metastases to skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Tumour compression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Renal failure
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Urinary retention
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Thrombophlebitis
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Hypertension
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0033 affected34 at risk
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Confusional state
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0013 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Overdose
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Hypoventilation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Lymphadenectomy
Surgical and medical procedures
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Ejection fraction decreased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Ichthyosis
Congenital, familial and genetic disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Macular detachment
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Abscess
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Lymphoedema
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
EG0007 affected49 at risk
EG0014 affected82 at risk
EG0021 affected15 at risk
EG0034 affected34 at risk
Hot flush
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0004 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hypotension
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG0011 affected82 at risk
EG0022 affected15 at risk
EG0030 affected34 at risk
Lymphoedema
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Thrombosis
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Thrombophlebitis
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Peripheral ischaemia
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Phlebitis superficial
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Vascular compression
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Flushing
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Haematoma
Vascular disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events2 affected82 at risk
EG0020 events0 affected15 at risk
EG0031 events1 affected34 at risk
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected15 at risk
EG0030 events0 affected34 at risk
Nodular melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected82 at risk
EG0020 events0 affected15 at risk
EG0030 events0 affected34 at risk
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected82 at risk
EG0020 events0 affected15 at risk
EG0031 events1 affected34 at risk
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Non-systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected82 at risk
EG0021 events1 affected15 at risk
EG0030 events0 affected34 at risk
Drug hypersensitivity
Immune system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Asthenia
General disorders
MedDRA 18.0
Non-systematic Assessment
EG00027 affected49 at risk
EG00138 affected82 at risk
EG0028 affected15 at risk
EG00312 affected34 at risk
Oedema peripheral
General disorders
MedDRA 18.0
Non-systematic Assessment
EG00012 affected49 at risk
EG00130 affected82 at risk
EG0029 affected15 at risk
EG00321 affected34 at risk
Pyrexia
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0009 affected49 at risk
EG00113 affected82 at risk
EG0023 affected15 at risk
EG00312 affected34 at risk
Fatigue
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0006 affected49 at risk
EG00116 affected82 at risk
EG0022 affected15 at risk
EG0038 affected34 at risk
Non-cardiac chest pain
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Chest pain
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Chills
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0034 affected34 at risk
Hyperthermia
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Inflammation
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Influenza like illness
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Mucosal inflammation
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0022 affected15 at risk
EG0033 affected34 at risk
Nodule
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Pain
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0032 affected34 at risk
Systemic inflammatory response syndrome
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Face oedema
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0013 affected82 at risk
EG0021 affected15 at risk
EG0038 affected34 at risk
Generalised oedema
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Hypothermia
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Mucosal dryness
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Oedema
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Peripheral swelling
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Thrombosis in device
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Xerosis
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0034 affected34 at risk
General physical health deterioration
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Localised oedema
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Feeling cold
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Injection site oedema
General disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Depression
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0014 affected82 at risk
EG0021 affected15 at risk
EG0032 affected34 at risk
Insomnia
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0016 affected82 at risk
EG0021 affected15 at risk
EG0034 affected34 at risk
Anxiety
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0017 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Confusional state
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hallucination
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Irritability
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Illusion
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Mood altered
Psychiatric disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Pelvic pain
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Breast pain
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Haematospermia
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Metrorrhagia
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Ovarian cyst
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Vulvovaginal dryness
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Ovarian vein thrombosis
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Genital rash
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Oedema genital
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Pruritus genital
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Scrotal erythema
Reproductive system and breast disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Tracheal obstruction
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Post procedural oedema
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0022 affected15 at risk
EG0030 affected34 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Rib fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Burn of internal organs
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Procedural pain
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Burn oesophageal
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Muscle injury
Injury, poisoning and procedural complications
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Weight decreased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0006 affected49 at risk
EG0018 affected82 at risk
EG0024 affected15 at risk
EG0032 affected34 at risk
Ejection fraction decreased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG0012 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Blood creatine phosphokinase increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0035 affected34 at risk
Intraocular pressure increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Blood 25-hydroxycholecalciferol decreased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Blood albumin decreased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Blood bilirubin increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Blood lactate dehydrogenase increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Blood parathyroid hormone increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Blood potassium increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Electrocardiogram qt prolonged
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Haemoglobin decreased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Heart rate increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Weight increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0033 affected34 at risk
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Blood creatinine increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
C-reactive protein increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Cardiac murmur
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Electrocardiogram pr prolongation
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Electrocardiogram repolarisation abnormality
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hepatic enzyme increased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Platelet count decreased
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Retinogram abnormal
Investigations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Tachycardia
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected82 at risk
EG0022 affected15 at risk
EG0030 affected34 at risk
Aortic valve incompetence
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Left ventricular dysfunction
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Diastolic dysfunction
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Left ventricular failure
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Atrial flutter
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Tricuspid valve incompetence
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Arrhythmia
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Atrioventricular block first degree
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Ventricular hypokinesia
Cardiac disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Colour blindness
Congenital, familial and genetic disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG00010 affected49 at risk
EG00122 affected82 at risk
EG0023 affected15 at risk
EG0032 affected34 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG0016 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG0016 affected82 at risk
EG0022 affected15 at risk
EG0031 affected34 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Lymph node pain
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0014 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Pancytopenia
Blood and lymphatic system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0006 affected49 at risk
EG00112 affected82 at risk
EG0024 affected15 at risk
EG0036 affected34 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0035 affected34 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0013 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0032 affected34 at risk
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Epiglottic oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Visual field defect
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG0017 affected82 at risk
EG0021 affected15 at risk
EG0035 affected34 at risk
Dysgeusia
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0035 affected34 at risk
Headache
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG00112 affected82 at risk
EG0021 affected15 at risk
EG0034 affected34 at risk
Somnolence
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0013 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Amnesia
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Dysaesthesia
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0022 affected15 at risk
EG0030 affected34 at risk
Neurotoxicity
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Paraesthesia
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Sciatica
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0014 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Speech disorder
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Syncope
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Coordination abnormal
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Dizziness
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0035 affected34 at risk
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Brain oedema
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Lethargy
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Loss of consciousness
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Memory impairment
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Viith nerve paralysis
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Presyncope
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0032 affected34 at risk
Ageusia
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Aphasia
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Apraxia
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Carpal tunnel syndrome
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Dysarthria
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Hypotonia
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Peripheral motor neuropathy
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Sensory loss
Nervous system disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Vision blurred
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0007 affected49 at risk
EG00120 affected82 at risk
EG0022 affected15 at risk
EG0036 affected34 at risk
Visual impairment
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0005 affected49 at risk
EG0014 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Colour blindness acquired
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0004 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Macular detachment
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG00114 affected82 at risk
EG0029 affected15 at risk
EG00316 affected34 at risk
Retinal detachment
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG00111 affected82 at risk
EG0023 affected15 at risk
EG00310 affected34 at risk
Eyelid oedema
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0015 affected82 at risk
EG0022 affected15 at risk
EG0036 affected34 at risk
Photopsia
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Retinal vein occlusion
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Visual acuity reduced
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0015 affected82 at risk
EG0022 affected15 at risk
EG0031 affected34 at risk
Altered visual depth perception
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Chromatopsia
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Corneal epithelium defect
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Diplopia
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Eye pain
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Lacrimation increased
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Macular oedema
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Metamorphopsia
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Ocular hyperaemia
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Ocular icterus
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Ulcerative keratitis
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Conjunctival oedema
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Eye haemorrhage
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Keratitis
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Retinal exudates
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Cataract
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Choroidal haemorrhage
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Conjunctivitis allergic
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Detachment of retinal pigment epithelium
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0033 affected34 at risk
Eye swelling
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Growth of eyelashes
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Macular degeneration
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Retinal pigment epitheliopathy
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Retinal vascular disorder
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Retinal vein thrombosis
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Ocular hypertension
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0022 affected15 at risk
EG0031 affected34 at risk
Periorbital oedema
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0022 affected15 at risk
EG0034 affected34 at risk
Eyelash discolouration
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Maculopathy
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Trichomegaly
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Retinal haemorrhage
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0033 affected34 at risk
Dry eye
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Erythema of eyelid
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Eye oedema
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Punctate keratitis
Eye disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG0015 affected82 at risk
EG0022 affected15 at risk
EG0032 affected34 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Vertigo positional
Ear and labyrinth disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Ear discomfort
Ear and labyrinth disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Hearing impaired
Ear and labyrinth disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG00025 affected49 at risk
EG00146 affected82 at risk
EG00214 affected15 at risk
EG00329 affected34 at risk
Nausea
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG00021 affected49 at risk
EG00126 affected82 at risk
EG0026 affected15 at risk
EG00315 affected34 at risk
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG00015 affected49 at risk
EG00128 affected82 at risk
EG0022 affected15 at risk
EG00311 affected34 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG00010 affected49 at risk
EG00112 affected82 at risk
EG0021 affected15 at risk
EG0038 affected34 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0009 affected49 at risk
EG00117 affected82 at risk
EG0021 affected15 at risk
EG00310 affected34 at risk
Constipation
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0009 affected49 at risk
EG00117 affected82 at risk
EG0025 affected15 at risk
EG0039 affected34 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0006 affected49 at risk
EG0016 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Ascites
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0017 affected82 at risk
EG0020 affected15 at risk
EG0036 affected34 at risk
Anal fistula
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0014 affected82 at risk
EG0022 affected15 at risk
EG0032 affected34 at risk
Faeces discoloured
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Flatulence
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0013 affected82 at risk
EG0022 affected15 at risk
EG0032 affected34 at risk
Melaena
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0014 affected82 at risk
EG0022 affected15 at risk
EG0032 affected34 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0014 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Aptyalism
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Cheilitis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0032 affected34 at risk
Haematochezia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hiatus hernia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Odynophagia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0022 affected15 at risk
EG0030 affected34 at risk
Subileus
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Gastritis
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0022 affected15 at risk
EG0030 affected34 at risk
Gastric polyps
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Anal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Regurgitation
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Chromaturia
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hydronephrosis
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Renal failure
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Dysuria
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Renal impairment
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Proteinuria
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Renal colic
Renal and urinary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Hepatic pain
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Cholestasis
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Jaundice
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Portal hypertension
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0009 affected49 at risk
EG00113 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0009 affected49 at risk
EG00118 affected82 at risk
EG0026 affected15 at risk
EG00314 affected34 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0007 affected49 at risk
EG00119 affected82 at risk
EG0027 affected15 at risk
EG00312 affected34 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0007 affected49 at risk
EG0019 affected82 at risk
EG0024 affected15 at risk
EG0036 affected34 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0006 affected49 at risk
EG00113 affected82 at risk
EG0026 affected15 at risk
EG0036 affected34 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0014 affected82 at risk
EG0024 affected15 at risk
EG0036 affected34 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0021 affected15 at risk
EG0036 affected34 at risk
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0023 affected15 at risk
EG0033 affected34 at risk
Skin toxicity
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0013 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0034 affected34 at risk
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0022 affected15 at risk
EG0031 affected34 at risk
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Nail bed inflammation
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0033 affected34 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Guttate psoriasis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Hirsutism
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Nail pigmentation
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Palmoplantar keratoderma
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Plantar erythema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Prurigo
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Purpura
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Scab
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Skin erosion
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0004 affected49 at risk
EG0017 affected82 at risk
EG0022 affected15 at risk
EG0032 affected34 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0014 affected82 at risk
EG0021 affected15 at risk
EG0035 affected34 at risk
Bone cyst
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0014 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0019 affected82 at risk
EG0022 affected15 at risk
EG0036 affected34 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0017 affected82 at risk
EG0020 affected15 at risk
EG0034 affected34 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0013 affected82 at risk
EG0021 affected15 at risk
EG0035 affected34 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0033 affected34 at risk
Osteolysis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Pubic pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Hyperthyroidism
Endocrine disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG00013 affected49 at risk
EG00111 affected82 at risk
EG0022 affected15 at risk
EG00310 affected34 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0004 affected49 at risk
EG00110 affected82 at risk
EG0022 affected15 at risk
EG0032 affected34 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG0014 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0017 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0013 affected82 at risk
EG0022 affected15 at risk
EG0030 affected34 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG00110 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Food intolerance
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Iron deficiency
Metabolism and nutrition disorders
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Lymphangitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0003 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Bronchitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0033 affected34 at risk
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0002 affected49 at risk
EG0012 affected82 at risk
EG0022 affected15 at risk
EG0031 affected34 at risk
Erysipelas
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0032 affected34 at risk
Folliculitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Fungal infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Herpes zoster
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Influenza
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Nosocomial infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Otitis media
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Paronychia
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0012 affected82 at risk
EG0022 affected15 at risk
EG0035 affected34 at risk
Pharyngitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0014 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Rhinitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Urinary tract infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0015 affected82 at risk
EG0021 affected15 at risk
EG0035 affected34 at risk
Herpes virus infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Oral fungal infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0012 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Anal infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Chorioretinitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Gastroenteritis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Genital herpes
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Laryngitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Oral herpes
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Sinusitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Staphylococcal sepsis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Tooth abscess
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Vulvovaginal candidiasis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0011 affected82 at risk
EG0020 affected15 at risk
EG0030 affected34 at risk
Acute tonsillitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Anal abscess
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Conjunctivitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0032 affected34 at risk
Furuncle
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Oral candidiasis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0021 affected15 at risk
EG0030 affected34 at risk
Ear infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Eye infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Lung infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Tinea pedis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0032 affected34 at risk
Cellulitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Fungal skin infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Onychomycosis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Respiratory tract infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Skin infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Staphylococcal infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0000 affected49 at risk
EG0010 affected82 at risk
EG0020 affected15 at risk
EG0031 affected34 at risk
Cystitis
Infections and infestations
MedDRA 18.0
Non-systematic Assessment
EG0001 affected49 at risk
EG0011 affected82 at risk
EG0021 affected15 at risk
EG0031 affected34 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
13
BG004101
14
BG00454
110
34
34
Serious TEAEs
Title
Measurements
OG00023
OG00145
OG0028
OG00321
TEAEs leading to discontinuation
Title
Measurements
OG00013
OG00122
OG0022
OG0036
35
2
34
0
Anaemia
Title
Measurements
OG00010
OG00123
OG0023
OG0033
Lymphopenia
Title
Measurements
OG0003
OG0017
OG0020
OG0030
Thrombocytopenia
Title
Measurements
OG0003
OG0016
OG0022
OG0031
Platelet count decreased
Title
Measurements
OG0000
OG0011
OG0020
OG0030
Neutropenia
Title
Measurements
OG0000
OG0014
OG0020
OG0031
Leukopenia
Title
Measurements
OG0000
OG0010
OG0021
OG0030
Pancytopenia
Title
Measurements
OG0000
OG0010
OG0020
OG0031
Hyponatraemia
Title
Measurements
OG0000
OG0011
OG0020
OG0031
Hypokalaemia
Title
Measurements
OG0004
OG00110
OG0022
OG0032
Hyperkalaemia
Title
Measurements
OG0001
OG0010
OG0020
OG0030
Hypocalcaemia
Title
Measurements
OG0002
OG0017
OG0020
OG0031
Hypercalcaemia
Title
Measurements
OG0000
OG0013
OG0020
OG0030
Hypomagnesaemia
Title
Measurements
OG0002
OG0013
OG0022
OG0030
Hypophosphataemia
Title
Measurements
OG0000
OG0012
OG0020
OG0030
Hepatic enzyme increased
Title
Measurements
OG0000
OG0011
OG0020
OG0030
Hepatic function abnormal
Title
Measurements
OG0000
OG0011
OG0020
OG0030
Alanine aminotransferase increased
Title
Measurements
OG0000
OG0011
OG0020
OG0032
Aspartate aminotransferase increased
Title
Measurements
OG0001
OG0011
OG0020
OG0032
Blood alkaline phosphatase increased
Title
Measurements
OG0001
OG0010
OG0020
OG0031
Hyperbilirubinaemia
Title
Measurements
OG0001
OG0011
OG0020
OG0030
Blood lactate dehydrogenase increased
Title
Measurements
OG0001
OG0010
OG0020
OG0031
Blood creatine phosphokinase increased
Title
Measurements
OG0001
OG0012
OG0021
OG0035
Blood creatinine increased
Title
Measurements
OG0000
OG0011
OG0020
OG0030
Blood 25-hydroxycholecalciferol decreased
Title
Measurements
OG0001
OG0011
OG0020
OG0030
Vitamin D decreased
Title
Measurements
OG0000
OG0011
OG0020
OG0030
Blood parathyroid hormone increased
Title
Measurements
OG0001
OG0011
OG0020
OG0030
Hyperglycaemia
Title
Measurements
OG0000
OG0011
OG0020
OG0030
C-reactive protein increased
Title
Measurements
OG0000
OG0011
OG0020
OG0030
Proteinuria
Title
Measurements
OG0000
OG0010
OG0021
OG0031
Hyperthyroidism
Title
Measurements
OG0000
OG0010
OG0020
OG0031
Hypoalbuminaemia
Title
Measurements
OG0003
OG0014
OG0020
OG0032
Weight increased
Title
Measurements
OG0000
OG0013
OG0020
OG0033
Weight decreased
Title
Measurements
OG0006
OG0018
OG0024
OG0032
Hyperthermia
Title
Measurements
OG0001
OG0015
OG0020
OG0031
Hypertension
Title
Measurements
OG0007
OG0015
OG0021
OG0034
Hypotension
Title
Measurements
OG0003
OG0011
OG0022
OG0030
Heart rate increased
Title
Measurements
OG0001
OG0010
OG0020
OG0030
Tachycardia
Title
Measurements
OG0003
OG0010
OG0022
OG0030
Blood potassium increased
Title
Measurements
OG0001
OG0010
OG0020
OG0030
3
OG0043
OG0053
OG0066
OG0073
OG0084
OG0093
OG01013
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG01013
Title
Measurements
OG0002.02± 41.0
OG0013.20± 45.5
OG0024.21± 47.9
OG0036.69± 62.9
OG00412.60± 15.4
OG00562.32± 33.6
OG006126.21± 70.2
OG007212.96± 106.3
OG008357.39± 30.7
OG009325.99± 31.8
OG010428.85± 57.9
C1D12
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG01011
Title
Measurements
OG0002.92± 39.0
OG0012.69± 10.1
OG0026.29± 40.6
OG003
C3D1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0092
ParticipantsOG0107
Title
Measurements
OG0002.00± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0012.90± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0025.60± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG003
3
OG0043
OG0055
OG0063
OG0073
OG0083
OG0093
OG0104
OG01114
OG01212
OG0135
3
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG01114
ParticipantsOG01212
ParticipantsOG0135
Title
Measurements
OG0001.65± 59.2
OG0012.87± 56.6
OG0024.55± 113.4
OG00317.26± 27.8
OG00430.90± 32.6
OG00539.19± 69.7
OG006187.98± 39.7
OG007321.85± 32.7
OG008306.63± 110.4
OG009373.59± 24.9
OG010605.11± 48.8
OG011539.02± 78.0
OG012680.87± 45.6
OG013990.92± 64.9
C1D15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG01110
ParticipantsOG01211
ParticipantsOG0134
Title
Measurements
OG0002.28± 58.0
OG0017.77± 96.2
OG0024.21± 39.9
OG003
C3D1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0118
ParticipantsOG0127
ParticipantsOG0133
Title
Measurements
OG0001.25± 5.7
OG0014.30± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0026.56± 39.8
OG003
305.94
± 45.6
OG001370.70± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG001402.77± 59.2
C1D15
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG000316.08± 34.9
OG001324.80± 65.8
C3D1
ParticipantsOG0002
ParticipantsOG00110
Title
Measurements
OG000473.27± 38.7
OG001376.62± 45.2
OG000132.57± 40.2
OG001206.46± 41.7
OG002263.08± 68.5
C1D15
ParticipantsOG0003
ParticipantsOG00118
ParticipantsOG00211
Title
Measurements
OG000178.09± 95.0
OG001231.12± 44.0
OG002190.42± 57.6
C3D1
ParticipantsOG0002
ParticipantsOG00113
ParticipantsOG0026
Title
Measurements
OG000139.60± 26.6
OG001157.46± 53.7
OG002329.28± 73.5
3
OG0043
OG0053
OG0066
OG0073
OG0084
OG0093
OG01013
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG01013
Title
Measurements
OG0001.500(1.02 to 1.53)
OG0010.750(0.50 to 4.25)
OG0021.500(1.00 to 2.50)
OG0031.500(1.00 to 2.17)
OG0041.500(1.00 to 2.50)
OG0051.000(0.50 to 2.00)
OG0061.500(1.00 to 4.00)
OG0071.017(1.00 to 2.50)
OG0081.000(0.98 to 1.50)
OG0091.483(0.52 to 2.17)
OG0101.017(0.50 to 6.00)
C1D12
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG01011
Title
Measurements
OG0001.633(0.50 to 2.50)
OG0010.533(0.33 to 2.00)
OG0021.000(1.00 to 2.50)
OG003
C3D1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0092
ParticipantsOG0107
Title
Measurements
OG0001.52(1.52 to 1.52)
OG0010.500(0.50 to 0.50)
OG0021.52(1.52 to 1.52)
OG003
3
OG0043
OG0055
OG0063
OG0073
OG0083
OG0093
OG0104
OG01114
OG01212
OG0135
3
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG01114
ParticipantsOG01212
ParticipantsOG0135
Title
Measurements
OG0001.500(1.50 to 1.92)
OG0011.017(0.50 to 2.50)
OG0021.500(1.00 to 2.00)
OG0031.000(0.50 to 24.98)
OG0040.533(0.52 to 2.00)
OG0051.500(0.50 to 4.00)
OG0061.000(0.58 to 2.02)
OG0070.500(0.50 to 1.02)
OG0081.000(0.47 to 1.50)
OG0091.500(0.50 to 1.58)
OG0101.250(0.33 to 2.02)
OG0111.500(0.58 to 4.00)
OG0121.250(0.50 to 2.50)
OG0132.000(0.50 to 2.50)
C1D15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG01110
ParticipantsOG01211
ParticipantsOG0134
Title
Measurements
OG0001.500(1.42 to 2.00)
OG0010.967(0.52 to 1.50)
OG0022.000(0.43 to 2.00)
OG003
C3D1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0118
ParticipantsOG0127
ParticipantsOG0133
Title
Measurements
OG0001.250(1.00 to 1.50)
OG0012.000(2.00 to 2.00)
OG0021.258(1.00 to 1.52)
OG003
2.033
(1.50 to 4.00)
OG0016.000(6.00 to 6.00)
OG0011.500(0.50 to 2.03)
C1D15
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0002.500(1.52 to 2.50)
OG0011.492(0.50 to 4.00)
C3D1
ParticipantsOG0002
ParticipantsOG00110
Title
Measurements
OG0002.000(1.50 to 2.50)
OG0011.000(0.57 to 2.10)
OG0001.500(1.00 to 2.00)
OG0011.000(0.50 to 4.00)
OG0020.667(0.47 to 2.50)
C1D15
ParticipantsOG0003
ParticipantsOG00118
ParticipantsOG00211
Title
Measurements
OG0001.500(1.03 to 2.00)
OG0011.500(0.50 to 2.55)
OG0021.500(0.97 to 4.08)
C3D1
ParticipantsOG0002
ParticipantsOG00113
ParticipantsOG0026
Title
Measurements
OG0001.467(0.92 to 2.02)
OG0011.183(0.50 to 2.07)
OG0021.467(0.50 to 1.57)
3
OG0043
OG0053
OG0066
OG0073
OG0084
OG0093
OG01013
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG01013
Title
Measurements
OG0004.6± 431.3
OG0015.2± 63.9
OG00218.5± 49.8
OG00322.7± 29.2
OG00452.7± 74.5
OG005213.9± 84.0
OG006531.3± 55.4
OG007889.0± 31.9
OG0081624.8± 36.1
OG0091748.1± 38.8
OG0102292.4± 52.5
C1D12
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0065
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG01011
Title
Measurements
OG0007.0± 269.8
OG0016.0± 89.3
OG00226.0± 55.0
OG003
C3D1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0092
ParticipantsOG0107
Title
Measurements
OG0006.9± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0012.7± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00221.0± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG003
3
OG0043
OG0055
OG0063
OG0073
OG0083
OG0093
OG0104
OG01114
OG01212
OG0135
3
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG01114
ParticipantsOG01212
ParticipantsOG0135
Title
Measurements
OG0001.9± 331.6
OG0018.2± 53.1
OG0026.7± 292.9
OG00367.9± 93.9
OG00474.4± 19.4
OG005188.4± 61.7
OG006625.7± 20.6
OG007808.0± 15.7
OG008861.1± 112.4
OG0091484.6± 13.0
OG0102287.0± 96.6
OG0112216.5± 75.7
OG0123415.6± 44.5
OG0134041.3± 60.8
C1D15
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG01110
ParticipantsOG01211
ParticipantsOG0134
Title
Measurements
OG0004.3± 228.5
OG00122.2± 42.1
OG00213.8± 66.9
OG003
C3D1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0118
ParticipantsOG0127
ParticipantsOG0133
Title
Measurements
OG0000.5± 76.6
OG00110.2± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00226.2± 15.6
OG003
1458.3
± 41.3
OG0015072.9± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0011544.9± 57.1
C1D15
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0001532.4± 80.4
OG0011428.8± 63.6
C3D1
ParticipantsOG0002
ParticipantsOG00110
Title
Measurements
OG0001392.3± 35.2
OG0011122.5± 45.2
OG000407.2± 40.7
OG001681.4± 43.7
OG002791.1± 62.3
C1D15
ParticipantsOG0003
ParticipantsOG00118
ParticipantsOG00211
Title
Measurements
OG000589.3± 66.5
OG001838.8± 43.9
OG002710.3± 65.0
C3D1
ParticipantsOG0002
ParticipantsOG00113
ParticipantsOG0026
Title
Measurements
OG000450.0± 57.1
OG001577.0± 72.5
OG0021005.0± 25.6
3
OG0043
OG0053
OG0066
OG0073
OG0084
OG0093
OG01012
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG01012
Title
Measurements
OG000136.2± 9.2
OG0016.2± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00255.5± 321.8
OG00331.4± 29.7
OG00461.3± 66.9
OG005234.1± 70.2
OG006574.2± 50.0
OG007924.2± 32.7
OG0081699.7± 36.1
OG0091836.4± 42.8
OG0102773.5± 54.7
C1D12
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0109
Title
Measurements
OG00038.3± 254.8
OG0019.4± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00243.8± 58.7
OG003
C3D1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0092
ParticipantsOG0106
Title
Measurements
OG00015.4± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00247.6± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00334.4± 37.6
OG004
3
OG0043
OG0055
OG0063
OG0073
OG0083
OG0093
OG0104
OG01114
OG01212
OG0135
2
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG01114
ParticipantsOG01212
ParticipantsOG0135
Title
Measurements
OG00123.4± 65.7
OG00223.6± 22.5
OG00359.1± 6.2
OG00490.3± 30.8
OG005218.4± 62.1
OG006646.9± 20.7
OG007820.4± 15.7
OG008885.8± 111.0
OG0091525.6± 13.2
OG0102424.2± 109.7
OG0112287.8± 77.4
OG0123602.2± 46.2
OG0134300.3± 54.2
C1D15
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0118
ParticipantsOG01210
ParticipantsOG0134
Title
Measurements
OG00015.7± 10.6
OG00133.3± 45.8
OG00221.9± 91.5
OG003
C3D1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0118
ParticipantsOG0127
ParticipantsOG0133
Title
Measurements
OG00115.4± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00241.2± 41.4
OG00349.5± 17.4
OG004
1495.7
± 41.8
OG0015633.8± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG000527.6± 57.4
OG001742.3± 47.1
OG002939.9± 67.3
C1D15
ParticipantsOG0003
ParticipantsOG00118
ParticipantsOG00211
Title
Measurements
OG000674.1± 73.6
OG0011004.2± 46.4
OG002978.4± 63.7
C3D1
ParticipantsOG0002
ParticipantsOG00113
ParticipantsOG0026
Title
Measurements
OG000696.0± 101.4
OG001700.8± 79.0
OG0021285.7± 29.0
OG0011581.4± 56.6
C1D15
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0001753.9± 93.1
OG0011517.1± 65.6
C3D1
ParticipantsOG0002
ParticipantsOG00110
Title
Measurements
OG0001597.0± 50.7
OG0011400.3± 53.0
2
OG0043
OG0053
OG0066
OG0073
OG0084
OG0093
OG01010
1
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG01010
Title
Measurements
OG0033.346± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0043.405± 52.1
OG0054.599± 29.1
OG0064.781± 39.4
OG0075.389± 9.4
OG0085.335± 23.6
OG0095.351± 15.9
OG0105.247± 17.1
C1D12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0092
ParticipantsOG0108
Title
Measurements
OG0034.985± 123.5
OG0049.249± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0053.236± 19.4
OG006
C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0103
Title
Measurements
OG0042.959± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0052.811± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0072.931± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG009
1
OG0042
OG0055
OG0063
OG0073
OG0083
OG0093
OG0104
OG01114
OG01212
OG0135
0
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG01114
ParticipantsOG01212
ParticipantsOG0135
Title
Measurements
OG0042.594± 5.0
OG0055.119± 30.5
OG0065.115± 6.6
OG0074.187± 10.3
OG0083.305± 84.0
OG0094.826± 14.0
OG0105.057± 45.3
OG0114.904± 18.8
OG0125.641± 21.6
OG0134.313± 29.6
C1D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0117
ParticipantsOG01210
ParticipantsOG0134
Title
Measurements
OG0032.941± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0042.335± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0054.443± 67.3
OG006
C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0123
ParticipantsOG0132
Title
Measurements
OG0032.732± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0083.477± 11.0
OG0092.853± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG010
4.534
± 18.3
OG0016.123± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0014.097± 33.5
C1D15
ParticipantsOG0002
ParticipantsOG00112
Title
Measurements
OG0005.259± 14.8
OG0015.599± 30.1
C3D1
ParticipantsOG0001
ParticipantsOG0016
Title
Measurements
OG0001.780± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0012.680± 21.1
OG0002.050± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0012.509± 25.1
OG0022.814± 20.2
C1D15
ParticipantsOG0003
ParticipantsOG00114
ParticipantsOG0027
Title
Measurements
OG0002.890± 23.8
OG0013.265± 18.6
OG0023.210± 23.8
C3D1
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG0022
Title
Measurements
OG0003.144± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0012.636± 17.0
OG0023.260± 10.6
2
OG0043
OG0053
OG0066
OG0073
OG0084
OG0093
OG01010
1
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG01010
Title
Measurements
OG003132.69± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG004114.26± 66.9
OG00559.80± 70.2
OG00648.76± 50.0
OG00748.69± 32.7
OG00840.01± 36.1
OG00950.45± 41.2
OG01047.82± 53.3
C1D12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0092
ParticipantsOG0108
Title
Measurements
OG00370.60± 77.3
OG00444.55± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00562.53± 92.6
OG006
C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0103
Title
Measurements
OG004217.56± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG005104.07± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00782.35± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG009
1
OG0042
OG0055
OG0063
OG0073
OG0083
OG0093
OG0104
OG01114
OG01212
OG0135
0
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG01114
ParticipantsOG01212
ParticipantsOG0135
Title
Measurements
OG00490.76± 18.3
OG00564.09± 62.1
OG00643.28± 20.7
OG00754.85± 15.7
OG00876.77± 111.0
OG00961.61± 13.2
OG01049.50± 109.7
OG01165.57± 77.4
OG01254.13± 46.2
OG01360.63± 53.4
C1D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0117
ParticipantsOG01210
ParticipantsOG0134
Title
Measurements
OG00359.55± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG004134.9± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00586.72± 12.5
OG006
C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0123
ParticipantsOG0132
Title
Measurements
OG00389.34± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00841.08± 19.1
OG00959.31± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG010
60.17
± 41.8
OG00126.62± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00156.91± 56.6
C1D15
ParticipantsOG0002
ParticipantsOG00112
Title
Measurements
OG00048.31± 103.9
OG00162.85± 63.6
C3D1
ParticipantsOG0001
ParticipantsOG0016
Title
Measurements
OG00053.36± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00175.63± 59.6
OG000114.82± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00180.83± 47.1
OG00283.86± 67.2
C1D15
ParticipantsOG0003
ParticipantsOG00114
ParticipantsOG0027
Title
Measurements
OG00071.44± 69.3
OG00166.89± 52.1
OG00294.48± 71.2
C3D1
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG0022
Title
Measurements
OG000126.1± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG001103.3± 66.9
OG00277.09± 21.0
2
OG0043
OG0053
OG0066
OG0073
OG0084
OG0093
OG01010
1
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG01010
Title
Measurements
OG003640.60± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG004561.27± 12.9
OG005396.76± 86.7
OG006336.32± 78.8
OG007378.56± 23.0
OG008307.90± 43.1
OG009389.49± 28.6
OG010361.99± 43.0
C1D12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0092
ParticipantsOG0108
Title
Measurements
OG003507.8± 28.3
OG004594.5± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG005291.9± 73.0
OG006
C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0103
Title
Measurements
OG004928.91± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG005422.04± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG007348.19± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG009
1
OG0042
OG0055
OG0063
OG0073
OG0083
OG0093
OG0104
OG01114
OG01212
OG0135
0
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG01114
ParticipantsOG01212
ParticipantsOG0135
Title
Measurements
OG004339.58± 13.2
OG005473.32± 81.2
OG006319.40± 27.0
OG007331.36± 13.3
OG008366.00± 22.8
OG009428.99± 22.7
OG010361.12± 58.1
OG011463.92± 68.7
OG012440.55± 41.7
OG013377.28± 42.4
C1D15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0102
ParticipantsOG0117
ParticipantsOG01210
ParticipantsOG0134
Title
Measurements
OG003252.7± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG004454.6± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG005555.9± 84.7
OG006
C3D1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0114
ParticipantsOG0123
ParticipantsOG0132
Title
Measurements
OG003352.10± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG008206.07± 30.5
OG009244.16± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG010
393.6
± 40.5
OG001235.2± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG001336.38± 47.1
C1D15
ParticipantsOG0002
ParticipantsOG00112
Title
Measurements
OG000366.5± 131.6
OG001507.7± 66.0
C3D1
ParticipantsOG0001
ParticipantsOG0016
Title
Measurements
OG000137.0± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG001292.5± 47.3
OG000339.51± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG001292.59± 42.3
OG002340.43± 57.7
C1D15
ParticipantsOG0003
ParticipantsOG00114
ParticipantsOG0027
Title
Measurements
OG000297.9± 57.8
OG001315.0± 59.4
OG002437.6± 59.1
C3D1
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG0022
Title
Measurements
OG000571.8± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG001392.9± 81.9
OG002362.6± 10.2
3
OG0043
OG0053
OG0066
OG0073
OG0084
OG0093
OG01012
3
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0066
ParticipantsOG0073
ParticipantsOG0084
ParticipantsOG0093
ParticipantsOG01012
Title
Measurements
OG00081.33± 21.2
OG00142.23± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00243.45± 79.8
OG00326.80± 27.3
OG00413.08± 47.7
OG0055.31± 174.3
OG0065.39± 112.5
OG0073.52± 52.0
OG0084.08± 47.3
OG0094.09± 75.2
OG0105.28± 155.8
C1D12
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0109
Title
Measurements
OG00050.60± 8.6
OG00133.84± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00240.60± 5.6
OG003
C3D1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0092
ParticipantsOG0106
Title
Measurements
OG00055.15± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00255.79± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00332.85± 14.3
OG004
3
OG0043
OG0055
OG0063
OG0073
OG0083
OG0093
OG0104
OG01114
OG01212
OG0135
2
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0104
ParticipantsOG01114
ParticipantsOG01212
ParticipantsOG0135
Title
Measurements
OG00155.78± 11.0
OG00231.63± 31.2
OG00327.25± 15.2
OG00415.10± 63.9
OG00512.17± 59.8
OG0063.29± 3.7
OG0071.46± 30.8
OG0082.66± 40.8
OG0092.60± 33.4
OG0102.94± 181.0
OG0112.64± 68.3
OG0124.36± 76.2
OG0133.57± 149.3
C1D15
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0118
ParticipantsOG01210
ParticipantsOG0134
Title
Measurements
OG00040.86± 2.9
OG00133.34± 6.4
OG00235.29± 30.0
OG003
C3D1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0118
ParticipantsOG0127
ParticipantsOG0133
Title
Measurements
OG00133.93± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00233.77± 47.7
OG00317.27± 45.0
OG004
2.21
± 56.3
OG0019.96± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0012.11± 50.0
C1D15
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0007.95± 149.3
OG0014.28± 85.0
C3D1
ParticipantsOG0002
ParticipantsOG00110
Title
Measurements
OG0009.11± 171.3
OG00117.56± 50.9
OG00016.82± 128.4
OG0017.70± 58.3
OG00210.90± 68.3
C1D15
ParticipantsOG0003
ParticipantsOG00118
ParticipantsOG00211
Title
Measurements
OG00011.78± 42.8
OG00114.14± 51.4
OG00219.19± 79.3
C3D1
ParticipantsOG0002
ParticipantsOG00113
ParticipantsOG0026
Title
Measurements
OG00030.63± 70.7
OG00116.43± 37.5
OG00221.34± 21.8
31
31
Title
Measurements
OG0004.524± 1.839
OG0013.937± 1.662
OG0024.121± 1.743
OG0033.629± 1.491
C1D1, 2 h post-dose (pERK)
ParticipantsOG00030
ParticipantsOG00163
ParticipantsOG00212
ParticipantsOG00330
Title
Measurements
OG0001.235± 0.295
OG0011.305± 0.755
OG0021.178± 0.194
OG003
C1D1, 4 h post-dose (pERK)
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0003.828± 1.715
OG0013.422± 1.902
C1D1, 8 h post-dose (pERK)
ParticipantsOG0009
ParticipantsOG00139
ParticipantsOG00212
ParticipantsOG00331
Title
Measurements
OG0001.454± 0.515
OG0011.454± 0.403
OG0021.878± 0.836
OG003
C1D2, Pre-dose (pERK)
ParticipantsOG0009
ParticipantsOG00140
ParticipantsOG00212
ParticipantsOG00325
Title
Measurements
OG0002.853± 1.399
OG0012.411± 1.031
OG0023.081± 1.249
OG003
C1D5, Pre-dose (pERK)
ParticipantsOG0008
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0002.722± 1.326
C1D8, Pre-dose (pERK)
ParticipantsOG00036
ParticipantsOG00169
ParticipantsOG00212
ParticipantsOG00328
Title
Measurements
OG0004.48± 2.119
OG0012.868± 1.473
OG0022.541± 1.338
OG003
C1D12-15, Pre-dose (pERK)
ParticipantsOG00037
ParticipantsOG00168
ParticipantsOG00212
ParticipantsOG00328
Title
Measurements
OG0003.257± 1.671
OG0013.265± 1.845
OG0023.241± 2.249
OG003
C1D12-15, 2 h Post-dose (pERK)
ParticipantsOG0008
ParticipantsOG00135
ParticipantsOG00212
ParticipantsOG00329
Title
Measurements
OG0001.252± 0.217
OG0011.293± 0.447
OG0021.471± 0.529
OG003
C1D12-15, 8 h Post-dose (pERK)
ParticipantsOG0008
ParticipantsOG00135
ParticipantsOG00212
ParticipantsOG00329
Title
Measurements
OG0001.514± 0.391
OG0011.653± 0.571
OG0021.902± 0.87
OG003
C1D12-15, 24 h Post-dose (pERK)
ParticipantsOG0006
ParticipantsOG00131
ParticipantsOG00212
ParticipantsOG00320
Title
Measurements
OG0002.768± 1.594
OG0012.476± 0.958
OG0022.598± 1.185
OG003
C3D1, Pre-dose (pERK)
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0005.179± 2.151
OG0013.716± 1.875
C3D1, 2 h Post-dose (pERK)
ParticipantsOG00012
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0001.795± 0.687
OG0011.288± 0.327
C3D1, 4 h Post-dose (pERK)
ParticipantsOG0004
ParticipantsOG0019
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0003.106± 0.461
OG0012.688± 2.065
C1D1, Pre-dose (Tot ERK)
ParticipantsOG00040
ParticipantsOG00174
ParticipantsOG00212
ParticipantsOG00331
Title
Measurements
OG0001.1± 0.468
OG0011.075± 0.25
OG0021.02± 0.169
OG003
C1D1, 2 h post-dose (Tot ERK)
ParticipantsOG00030
ParticipantsOG00161
ParticipantsOG00212
ParticipantsOG00330
Title
Measurements
OG0001.063± 0.215
OG0011.069± 0.247
OG0021.078± 0.151
OG003
C1D1, 4 h post-dose (Tot ERK)
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0001.059± 0.621
OG0011.012± 0.286
C1D1, 8 h post-dose (Tot ERK)
ParticipantsOG0009
ParticipantsOG00137
ParticipantsOG00212
ParticipantsOG00331
Title
Measurements
OG0001.058± 0.16
OG0011.095± 0.31
OG0021.078± 0.143
OG003
C1D2, Pre-dose (Tot ERK)
ParticipantsOG0009
ParticipantsOG00138
ParticipantsOG00212
ParticipantsOG00325
Title
Measurements
OG0001.075± 0.103
OG0011.13± 0.455
OG0021.013± 0.273
OG003
C1D5, Pre-dose (Tot ERK)
ParticipantsOG0008
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0001.163± 0.146
C1D8, Pre-dose (Tot ERK)
ParticipantsOG00036
ParticipantsOG00167
ParticipantsOG00212
ParticipantsOG00328
Title
Measurements
OG0001.233± 0.674
OG0011.108± 0.353
OG0020.944± 0.117
OG003
C1D12-15, Pre-dose (Tot ERK)
ParticipantsOG00037
ParticipantsOG00166
ParticipantsOG00212
ParticipantsOG00328
Title
Measurements
OG0001.223± 0.476
OG0011.118± 0.268
OG0021.333± 0.878
OG003
C1D12-15, 2 h Post-dose (Tot ERK)
ParticipantsOG0008
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00329
Title
Measurements
OG0001.04± 0.102
OG0011.125± 0.34
OG0021.335± 0.754
OG003
C1D12-15, 8 h Post-dose (Tot ERK)
ParticipantsOG0008
ParticipantsOG00133
ParticipantsOG00212
ParticipantsOG00329
Title
Measurements
OG0000.994± 0.165
OG0011.041± 0.237
OG0021.044± 0.238
OG003
C1D12-15, 24 h Post-dose (Tot ERK)
ParticipantsOG0006
ParticipantsOG00129
ParticipantsOG00212
ParticipantsOG00320
Title
Measurements
OG0001.047± 0.153
OG0011.045± 0.183
OG0021.048± 0.139
OG003
C3D1, Pre-dose (Tot ERK)
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0001.074± 0.34
OG0011.138± 0.306
C3D1, 2 h Post-dose (Tot ERK)
ParticipantsOG00012
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0001.087± 0.413
OG0011.251± 0.29
C3D1, 4 h Post-dose (Tot ERK)
ParticipantsOG0004
ParticipantsOG0019
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0000.674± 0.304
OG0011.052± 0.182
33
1
PR
Title
Measurements
OG0000
OG0014
OG0022
OG0036
SD
Title
Measurements
OG00019
OG00134
OG0029
OG00314
PD
Title
Measurements
OG00020
OG00133
OG0024
OG00312
9.75
± 63.3
OG00421.93± 110.5
OG00554.47± 116.2
OG006150.67± 78.1
OG007175.94± 47.5
OG008413.58± 9.1
OG009602.12± 11.0
OG010425.26± 71.0
8.06
± 30.3
OG00410.90± 68.5
OG00551.30± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00684.70± 78.8
OG007167.75± 15.5
OG009282.44± 14.9
OG010652.70± 48.3
18.78
± 32.2
OG00418.47± 33.1
OG00534.87± 36.8
OG006131.71± 14.7
OG007286.88± 21.8
OG008539.17± 37.1
OG009432.46± 7.6
OG010492.81± 117.1
OG011450.29± 67.4
OG012629.85± 71.3
OG0131535.60± 57.1
14.81
± 50.1
OG00416.10± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00696.60± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG008710.94± 57.4
OG009532.80± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG010568.49± 76.2
OG011795.86± 50.0
OG012773.14± 51.0
OG0132344.91± 23.1
1.000
(1.00 to 1.08)
OG0041.017(1.00 to 1.05)
OG0051.500(1.50 to 1.50)
OG0061.000(0.50 to 3.92)
OG0072.000(0.75 to 2.52)
OG0081.000(0.50 to 4.00)
OG0091.500(1.50 to 2.00)
OG0101.083(0.52 to 8.00)
1.000
(0.50 to 2.67)
OG0041.517(1.00 to 4.05)
OG0051.500(1.50 to 1.50)
OG0061.000(1.00 to 3.58)
OG0071.508(0.50 to 2.52)
OG0091.767(1.50 to 2.03)
OG0102.000(0.50 to 4.00)
0.667
(0.50 to 2.50)
OG0041.008(1.00 to 1.02)
OG0051.500(1.50 to 4.00)
OG0061.017(0.50 to 2.12)
OG0071.500(0.67 to 1.52)
OG0081.250(1.00 to 1.50)
OG0091.500(1.50 to 2.02)
OG0102.000(1.00 to 2.08)
OG0111.517(1.00 to 7.92)
OG0121.250(0.50 to 3.00)
OG0131.458(1.00 to 2.00)
1.000
(1.00 to 1.00)
OG0042.500(2.50 to 2.50)
OG0061.50(1.50 to 1.50)
OG0080.500(0.50 to 0.50)
OG0092.000(2.00 to 2.00)
OG0101.042(0.58 to 1.50)
OG0111.333(1.00 to 2.10)
OG0121.000(0.50 to 2.02)
OG0131.000(1.00 to 1.67)
35.9
± 79.7
OG00483.6± 67.7
OG005182.0± 125.1
OG006691.9± 51.4
OG007880.0± 45.7
OG0081900.3± 99.7
OG0091991.4± 19.2
OG0101682.4± 52.4
23.0
± 38.2
OG00445.2± 51.8
OG005113.2± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG006334.9± 47.8
OG007666.3± 52.3
OG009876.7± 20.4
OG0102064.1± 55.0
79.3
± 57.9
OG00467.8± 53.9
OG005161.5± 14.1
OG006621.2± 12.7
OG007906.3± 15.4
OG0081553.9± 122.5
OG0091826.2± 17.9
OG0101862.3± 96.4
OG0112086.6± 69.9
OG0123436.8± 64.7
OG0135765.9± 15.3
40.5
± 26.9
OG00446.1± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG006306.2± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0081394.7± 24.6
OG0091299.3± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0102053.6± 71.1
OG0112171.2± 59.4
OG0122484.5± 53.6
OG0134906.3± 19.2
47.5
± 68.1
OG004105.6± 57.6
OG005206.3± 106.5
OG006805.6± 58.9
OG007960.7± 46.9
OG0082108.2± 115.0
OG0092257.6± 30.1
OG0102022.8± 41.3
55.5
± 90.0
OG005134.5± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG006489.8± 55.2
OG0071072.1± 121.6
OG0091056.0± 26.6
OG0103477.6± 102.0
102.0
± 63.6
OG00489.7± 85.9
OG005172.2± 9.0
OG006669.1± 10.5
OG007933.9± 15.4
OG0081665.2± 132.1
OG0091893.2± 17.5
OG0102129.0± 123.7
OG0112029.9± 63.3
OG0123900.8± 64.3
OG0136232.1± 7.0
58.1
± NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG006415.6± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0081655.1± 19.1
OG0091584.8± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0102461.3± 64.3
OG0112796.2± 59.3
OG0123452.9± 61.6
OG0135651.1± 23.5
6.750
± 21.5
OG0074.688± 60.4
OG0086.926± 33.6
OG0095.672± 15.4
OG0103.964± 44.7
2.842
± NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG0103.038± 3.4
6.646
± 19.5
OG0075.277± 8.0
OG0086.441± 28.4
OG0095.193± 11.1
OG0104.851± 7.9
OG0115.479± 14.1
OG0126.016± 18.9
OG0134.847± 16.4
2.863
± 22.0
OG0112.418± 25.2
OG0122.628± 9.4
OG0132.260± 34.4
37.49
± 55.2
OG00749.37± 43.8
OG00835.80± 99.7
OG00950.88± 19.6
OG01061.44± 42.3
107.06
± NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG01072.25± 35.7
45.10
± 12.7
OG00749.65± 15.4
OG00843.76± 122.4
OG00951.47± 17.9
OG01092.42± 84.1
OG01181.22± 65.4
OG01253.49± 64.3
OG01342.20± 5.9
48.76
± 64.3
OG01161.04± 53.0
OG01272.33± 63.8
OG01344.23± 37.5
365.1
± 35.0
OG007333.9± 65.1
OG008357.8± 53.7
OG009416.3± 35.8
OG010351.4± 37.5
438.91
± NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG010316.63± 33.9
432.5
± 30.7
OG007378.0± 23.6
OG008406.6± 76.5
OG009385.6± 25.9
OG010646.9± 96.3
OG011642.1± 63.5
OG012464.2± 64.9
OG013295.1± 13.4
201.39
± 95.6
OG011212.92± 34.4
OG012274.24± 53.8
OG013144.24± 79.1
21.27
± 56.8
OG00419.82± 37.6
OG0057.83± 193.6
OG0066.57± 45.0
OG0078.17± 29.1
OG0086.56± 185.5
OG0097.94± 131.8
OG0102.97± 137.2
21.27
± 33.1
OG00515.84± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00628.06± 30.6
OG00727.67± 126.0
OG00916.54± 30.2
OG01026.05± 98.7
21.93
± 20.2
OG00419.45± 107.4
OG00512.45± 58.0
OG0066.89± 32.9
OG0072.96± 1.9
OG0085.00± 141.4
OG0093.40± 33.9
OG0105.82± 251.8
OG0114.82± 82.9
OG0125.77± 72.8
OG0135.22± 112.2
20.68
± NA
Geometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00626.32± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.
OG00815.35± 29.7
OG00918.02± NAGeometric Coefficient of Variation could not be calculated as there was only 1 subject analyzed in this reporting group.