Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subject... | NCT01390818 | Trialant
NCT01390818
Sponsor
EMD Serono
Status
Completed
Last Update Posted
Mar 7, 2017Actual
Enrollment
146Actual
Phase
Phase 1
Conditions
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Breast Cancer
Non Small Cell Lung Cancer
Melanoma
Colorectal Cancer
Interventions
MSC1936369B (pimasertib)
SAR245409 (PI3K and mTOR inhibitor)
MSC1936369B (pimasertib)
SAR245409 (PI3K and mTOR inhibitor)
Countries
United States
Italy
Spain
Protocol Section
Identification Module
NCT ID
NCT01390818
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EMR 200066-006
Secondary IDs
Not provided
Brief Title
Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
Official Title
An Open-Label, Phase Ib Dose Escalation Trial of Oral Combination Therapy With MSC1936369B and SAR245409 in Subjects With Locally Advanced or Metastatic Solid Tumors
Acronym
Not provided
Organization
EMD SeronoINDUSTRY
Status Module
Record Verification Date
Jan 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2011
Primary Completion Date
Apr 2015Actual
Completion Date
Apr 2015Actual
First Submitted Date
Apr 18, 2011
First Submission Date that Met QC Criteria
Jul 8, 2011
First Posted Date
Jul 11, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
May 1, 2016
Results First Submitted that Met QC Criteria
Jan 17, 2017
Results First Posted Date
Mar 7, 2017Actual
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
Jan 17, 2017
Last Update Posted Date
Mar 7, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
EMD SeronoINDUSTRY
Collaborators
Name
Class
Sanofi
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 research trial is testing a combination of two experimental drugs, MSC1936369B (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR) inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary purpose of the study is to determine the maximum tolerated dose of the drug combination.
Detailed Description
Not provided
Conditions Module
Conditions
Locally Advanced Solid Tumor
Metastatic Solid Tumor
Breast Cancer
Non Small Cell Lung Cancer
Melanoma
Colorectal Cancer
Keywords
MEK inhibitor (Pimasertib)
PI3K/mTOR Inhibitor
Solid Tumor
Phase I
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
146Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MSC1936369B and SAR245409 once daily
Experimental
Drug: MSC1936369B (pimasertib)
Drug: SAR245409 (PI3K and mTOR inhibitor)
MSC1936369B and SAR245409 twice daily
Experimental
Drug: MSC1936369B (pimasertib)
Drug: SAR245409 (PI3K and mTOR inhibitor)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MSC1936369B (pimasertib)
Drug
MSC1936369B (pimasertib) single dose capsule was administered at dose of 15 milligram (mg), 30 mg, 60 mg, 90 mg orally in successive 21-day cycles.Dose escalation was proceeded until Maximum Tolerated Dose (MTD) was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohorts enrolled subjects with Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Melanoma, and Colorectal Cancer.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Dose Limiting Toxicities (DLT)
DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of > 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption > 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.
Day 1 up to Day 16 in cycle 1
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) 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. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject with advanced solid tumors for which there is no approved therapy:
Advanced solid tumor with diagnosed alteration in one or more of the following genes (PTEN, BRAF, KRAS, NRAS, PI3KCA, ErbB1, ErbB2, MET, RET, c-KIT, GNAQ, GNA11 and/or
A histologically or cytologically confirmed diagnosis of one of the following solid tumors: pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal, breast, ovarian carcinoma and melanoma
Subject with archived tumor tissue available for transfer to the Sponsor
Subject enrolled at lower dose level cohorts and MTD expansion cohorts must have tumor available for biopsy and agree to pre-treatment and on-treatment tumor biopsies
Subject has measurable or evaluable disease by response evaluation criteria in solid tumors (RECIST) v1.1
Subject is aged greater than or equal to (>=) 18 years
Subjects enrolled in disease specific expansion cohorts must fulfill all the inclusion/exclusion criteria listed above with the following restriction to the Inclusion Criterion number 1:
Relapsed or refractory Kirsten rat sarcoma viral oncogene homolog (KRAS) or neuroblastoma RAS viral oncogene homolog (NRAS) mutated metastatic non-small cell lung cancer (NSCLC) with no approved therapies, or
Relapsed or refractory metastatic triple negative breast cancer defined as estrogen, progesterone and HER2 negative carcinoma of the breast with no approved therapies, or
Relapsed or refractory metastatic colorectal cancer (CRC) with dual KRAS and PIK3CA mutation with no approved therapies, or
BRAF V600E/K mutated unresectable or metastatic melanoma after progression on B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitors
Other protocol-defined inclusion criteria could apply
Exclusion Criteria:
Subject has been previously treated with a PI3K inhibitor or a MEK inhibitor and taken off treatment due to treatment related adverse events
Subject has received:
Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anti-cancer therapy within 28 days of trial drug treatment
Any investigational agent within 28 days of trial drug treatment
Extensive prior radiotherapy on more than 30% bone marrow reserves, or prior bone marrow/stem cell transplantation
Subject has not recovered from toxicity due to prior therapy
Subject has poor organ and marrow function as defined in the protocol
Subject has a history of central nervous system metastases, unless subject has been previously treated for CNS metastases
Subject has a history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease
Subject has a history of recent major surgery or trauma within the last 28 days.
Subject has participated in another clinical trial within the past 30 days
Other protocol-defined exclusion criteria could apply
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
82 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Responsible
EMD Serono, a business of Merck KGaA, Darmstadt, Germany
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pinnacle Oncology Hematology
Scottsdale
Arizona
85258
United States
Cedars Sinai Medical Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Study had a 4-day Drug-Drug Interaction (DDI) period, within 1 week prior to Day 1 Cycle 1, to assess possible interaction only in selected subjects where in SAR245409 and Pimasertib were administered alone on Day 1 and Day 3, respectively.
Recruitment Details
First subject (informed consent): May 2011. Study completion date: Apr 2015. A total of 192 subjects were screened and 146 subjects entered the trial and received the investigational medicinal product (IMP).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (Dose Escalation [DE] cohort).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MSC1936369B and SAR245409 once daily
Pimasertib
SAR245409 (PI3K and mTOR inhibitor)
Drug
SAR245409 (PI3K and mTOR inhibitor) capsule was administered orally at a dose of 30 mg, 50 mg, 70 mg and 90 mg in successive 21-day cycles. Dose escalation was proceeded until MTD was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohort enrolled subjects with Breast Cancer, NSCLC, Melanoma, and Colorectal Cancer.
MSC1936369B and SAR245409 once daily
PI3K and mTOR inhibitor
MSC1936369B (pimasertib)
Drug
MSC1936369B (pimasertib) capsule was administered twice daily orally at a dose of 60 mg and 45 mg in successive 21-day cycles. Dose escalation proceeded until MTD was reached. The maximum tolerated dose of MSC1936369B (pimasertib) was combined with a lower dose of SAR245409 (PI3K and mTOR inhibitor).
MSC1936369B and SAR245409 twice daily
pimasertib
SAR245409 (PI3K and mTOR inhibitor)
Drug
SAR245409 (PI3K and mTOR inhibitor) was administered twice daily orally at a dose of 30 mg and 50 mg in successive 21-day cycles. Dose escalation proceeded until MTD was reached. The maximum tolerated dose of SAR245409 (PI3K and mTOR inhibitor) was combined with a lower dose of MSC1936369B (pimasertib).
MSC1936369B and SAR245409 twice daily
PI3K and mTOR inhibitor
Baseline up to 30 Days after last dose; assessed up to 4 years
Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B)
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B)
Area under the concentration-time curve from time 0 to the last quantifiable concentration.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1
Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.
Terminal rate constant (λz).
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts
Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B)
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Half-Life (t1/2) of MSC1936369B (Pimasertib)
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Total Body Clearance (CL/f) of Pimasertib (MSC1936369B)
The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib
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 after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of Vz/f.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Accumulation Ratio (Racc) for AUCtau of Pimasertib (MSC1936369B): Day 15
Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau per Day 1 dosing interval AUCtau.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Accumulation Ratio (Racc) for Cmax of Pimasertib (MSC1936369B): Day 15
Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax/Day 1 Cmax.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Maximum Observed Plasma Concentration (Cmax) for SAR245409
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409
The time to reach maximum plasma concentration (Tmax) of SAR245409 was calculated.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time (0-24 hours) at which the concentration is at or above the lower limit of quantification. Unit of assessment was hour*nanogram per milliliter (hr*ng/mL).
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of SAR245409
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (0-inf) of SAR245409: Day 1
Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.
Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts
Apparent Terminal Half-Life (t1/2) of SAR245409
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Total Body Clearance (CL/f) of SAR245409
The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the dose with area under the plasma concentration time curve from time zero to infinity (AUC 0-inf)=Dose/AUC 0-inf.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f)
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 after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Accumulation Ratio (Racc) for AUCtau of SAR245409: Day 15
Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau divided by Day 1 dosing interval AUCtau.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
Accumulation Ratio (Racc) for Cmax of SAR245409: Day 15
Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax divided by Day 1 Cmax.
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs)
pS6 Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for "Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily", "Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily", "Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily" and "Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily" reporting arms.
DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); Cycle 1 Day 1 (C1D1) and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)
pERK Concentrations in PBMCs
pERK Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for "Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily", "Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily", "Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily" and "Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily" reporting arms.
DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); C1D1 and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)
Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD)
CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From the date of randomisation every 6 weeks up to assessed up to 4 years
Los Angeles
California
90048
United States
Massachusetts General Hospital
Boston
Massachusetts
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37205
United States
Cancer Therapy and Research Center
San Antonio
Texas
78229
United States
Merck Serono Research Site
Milan
Italy
Merck Serono Research Site
Madrid
Spain
FG001
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG002
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG003
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG004
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG005
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG006
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG007
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG008
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG009
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG010
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
FG011
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
FG012
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
FG013
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
FG014
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0044 subjects
FG0053 subjects
FG00619 subjects
FG00714 subjects
FG0083 subjects
FG0093 subjects
FG0104 subjects
FG01126 subjects
FG01224 subjects
FG01318 subjects
FG01415 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0044 subjects
FG0053 subjects
FG00619 subjects
FG00714 subjects
FG0083 subjects
FG0093 subjects
FG0104 subjects
FG01126 subjects
FG01224 subjects
FG01318 subjects
FG01415 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
The Safety analysis set (SAF) included subjects who received at least one (non-zero) administration of the trial IMPs (pimasertib and/or SAR245409).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG001
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG002
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG003
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG004
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG005
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG006
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG007
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG008
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG009
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG010
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
BG011
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
BG012
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
BG013
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
BG014
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0034
BG0044
BG0053
BG00619
BG00714
BG0083
BG0093
BG0104
BG01126
BG01224
BG01318
BG01415
BG015146
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Gender
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Subjects With Dose Limiting Toxicities (DLT)
DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of > 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption > 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.
The dose escalation (DE) analysis set included all subjects treated in DE cohorts who received at least 80 percent (%) of pimasertib and 80% of SAR245409 full planned doses in the first cycle (ie, 21-day period from Day 1) of treatment or who experienced a DLT during the first cycle of treatment regardless of the received amount of each drug.
Posted
Number
subjects
Day 1 up to Day 16 in cycle 1
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG001
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG002
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG003
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG004
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) 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. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose.
The safety analysis set (SAF) analysis set was to include all subjects who had received at least 1 (non-zero) administration of the trial investigational medicinal products (IMPs) MSC1936369B (pimasertib) and/or SAR245409.
Posted
Number
subjects
Baseline up to 30 Days after last dose; assessed up to 4 years
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG001
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Secondary
Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)
The pharmacokinetic (PK) analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
nanogram/millilitre (ng/mL)
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG002
Pimasertib (MSC1936369B) 60mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B)
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Median
Full Range
hour
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG002
Pimasertib (MSC1936369B) 60mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
Secondary
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B)
Area under the concentration-time curve from time 0 to the last quantifiable concentration.
The PK analysis set . Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
hour*nanogram per millilitre (hr*ng/mL)
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG002
Pimasertib (MSC1936369B) 60mg
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1
Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.
Terminal rate constant (λz).
The PK analysis set. Here "N" signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf.
Posted
Geometric Mean
95% Confidence Interval
hr*ng/mL
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B)
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
hr*ng/mL
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
Pimasertib (MSC1936369B) 60mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Half-Life (t1/2) of MSC1936369B (Pimasertib)
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Median
Full Range
hour
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
Pimasertib (MSC1936369B) 60mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Total Body Clearance (CL/f) of Pimasertib (MSC1936369B)
The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.
The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
litre per hour (L/hr)
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib
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 after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of Vz/f.
The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at specific time points.
Posted
Geometric Mean
95% Confidence Interval
liter
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Accumulation Ratio (Racc) for AUCtau of Pimasertib (MSC1936369B): Day 15
Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau per Day 1 dosing interval AUCtau.
The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
ratio
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
Pimasertib (MSC1936369B) 60mg
Secondary
Accumulation Ratio (Racc) for Cmax of Pimasertib (MSC1936369B): Day 15
Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax/Day 1 Cmax.
The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
ratio
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
Pimasertib (MSC1936369B) 60mg
Secondary
Maximum Observed Plasma Concentration (Cmax) for SAR245409
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
nanogram per millilitre (ng/mL)
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409
The time to reach maximum plasma concentration (Tmax) of SAR245409 was calculated.
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Median
Full Range
hours
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time (0-24 hours) at which the concentration is at or above the lower limit of quantification. Unit of assessment was hour*nanogram per milliliter (hr*ng/mL).
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
hr*ng/mL
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
SAR245409 70mg
Secondary
Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of SAR245409
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
hr*ng/mL
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (0-inf) of SAR245409: Day 1
Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.
Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.
The PK analysis set. Here "N" signifies number of subjects evaluable for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
hr*ng/mL
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Apparent Terminal Half-Life (t1/2) of SAR245409
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Median
Full Range
hour
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Total Body Clearance (CL/f) of SAR245409
The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the dose with area under the plasma concentration time curve from time zero to infinity (AUC 0-inf)=Dose/AUC 0-inf.
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
litre per hour
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
SAR245409 70mg
Secondary
Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f)
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 after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.
The PK analysis set. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
litre
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
Secondary
Accumulation Ratio (Racc) for AUCtau of SAR245409: Day 15
Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau divided by Day 1 dosing interval AUCtau.
The PK analysis set. Here "N" signifies number of participant analyzed for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
ratio
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
Accumulation Ratio (Racc) for Cmax of SAR245409: Day 15
Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax divided by Day 1 Cmax.
The PK analysis set. Here "N" signifies number of participant analyzed for this outcome measure and "n" signifies the number of subjects evaluable at the specific time points.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts
ID
Title
Description
OG000
SAR245409 30mg
SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
SAR245409 50mg
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
Secondary
pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs)
pS6 Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for "Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily", "Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily", "Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily" and "Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily" reporting arms.
The Biomarker Analysis Set for pharmacodynamics (PD) marker analysis in PBMC included all subjects who received at least the first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here "n" signifies the number of subjects evaluable at the specific time points.
Posted
Mean
Standard Deviation
fluorescence intensity
DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); Cycle 1 Day 1 (C1D1) and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Secondary
pERK Concentrations in PBMCs
pERK Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for "Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily", "Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily", "Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily" and "Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily" reporting arms.
Biomarker Analysis Set for pharmacodynamics marker analysis in PBMC included all subjects who received at least first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here "N" signifies number of subject analysed for this outcome measure" and "n" signifies number of subject analysed at specific time point.
Posted
Mean
Standard Deviation
fluorescence intensity
DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); C1D1 and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Secondary
Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD)
CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The Efficacy Analysis Set (EEF) included all subjects who received at least 1 trial treatment dose (Pimasertib or SAR245409) and had radiographic baseline and at least one evaluable post baseline tumor assessment.
Posted
Number
subjects
From the date of randomisation every 6 weeks up to assessed up to 4 years
ID
Title
Description
OG000
Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG001
Time Frame
Baseline up to 30 Days after last dose; assessed up to 4 years
Description
Not provided
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 (Pimasertib) 15mg and SAR245409 30mg Once Daily
MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
1
3
3
3
EG001
MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily
MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
0
3
3
3
EG002
MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily
MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
2
3
3
3
EG003
MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily
MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
1
4
4
4
EG004
MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily
MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
1
4
4
4
EG005
MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily
MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
1
3
3
3
EG006
MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily
MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
14
19
19
19
EG007
MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily
MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
10
14
14
14
EG008
MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily
MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort).
1
3
3
3
EG009
MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily
MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
2
3
3
3
EG010
MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily
MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
3
4
4
4
EG011
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
16
26
26
26
EG012
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily
Participants with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
13
24
24
24
EG013
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily
Participants with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
10
18
18
18
EG014
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily
Participants with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
8
15
15
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
FEBRILE NEUTROPENIA
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected4 at risk
EG004
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PYREXIA
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DISEASE PROGRESSION
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BILE DUCT OBSTRUCTION
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HEPATIC FAILURE
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PELVIC ABSCESS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SUBDURAL HAEMATOMA
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FAILURE TO THRIVE
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GROIN PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
METASTASES TO CENTRAL NERVOUS SYSTEM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TUMOUR HAEMORRHAGE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HALLUCINATION
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MENTAL STATUS CHANGES
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VULVOVAGINAL PAIN
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DERMATITIS EXFOLIATIVE
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FATIGUE
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BILE DUCT STENOSIS
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SUPERIOR VENA CAVA SYNDROME
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TEMPORAL ARTERITIS
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ATRIAL FLUTTER
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ANAEMIA
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BRADYCARDIA
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CARDIO-RESPIRATORY ARREST
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RIGHT VENTRICULAR DYSFUNCTION
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
INTESTINAL ISCHAEMIA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LARGE INTESTINAL OBSTRUCTION
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FATIGUE
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GENERALISED OEDEMA
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SEPSIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ABDOMINAL INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ESCHERICHIA INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ESCHERICHIA SEPSIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ACCIDENTAL OVERDOSE
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HUMERUS FRACTURE
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
OVERDOSE
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ELECTROCARDIOGRAM QT PROLONGED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HEMIPARESIS
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SPINAL CORD COMPRESSION
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PSYCHOTIC DISORDER
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ACUTE RESPIRATORY FAILURE
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EMBOLISM
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ANAPHYLACTIC REACTION
Immune system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG0031 affected4 at risk
EG0041 affected4 at risk
EG0050 affected3 at risk
EG0067 affected19 at risk
EG0073 affected14 at risk
EG0081 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0114 affected26 at risk
EG0122 affected24 at risk
EG0134 affected18 at risk
EG0140 affected15 at risk
THROMBOCYTOPENIA
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LEUKOPENIA
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
IRON DEFICIENCY ANAEMIA
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ANAEMIA MACROCYTIC
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NEUTROPENIA
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SINUS TACHYCARDIA
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
PALPITATIONS
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ATRIAL FLUTTER
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PERICARDIAL EFFUSION
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TACHYCARDIA
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SINUS BRADYCARDIA
Cardiac disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HEARING IMPAIRED
Ear and labyrinth disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VERTIGO
Ear and labyrinth disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOTHYROIDISM
Endocrine disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SUBRETINAL FLUID
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VISUAL ACUITY REDUCED
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VISUAL IMPAIRMENT
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RETINAL DETACHMENT
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PERIORBITAL OEDEMA
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DETACHMENT OF RETINAL PIGMENT EPITHELIUM
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MACULAR DETACHMENT
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VITREOUS FLOATERS
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PHOTOPSIA
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RETINAL HAEMORRHAGE
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLEPHARITIS
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
CATARACT
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
CHORIORETINOPATHY
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DIPLOPIA
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DRY EYE
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EYE OEDEMA
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EYE PAIN
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GLAUCOMA
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MACULAR FIBROSIS
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MACULAR HOLE
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RETINAL EXUDATES
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
XANTHOPSIA
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Halo Vision
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EYE COLOUR CHANGE
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EYE DISCHARGE
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EYE PRURITUS
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EYELID FUNCTION DISORDER
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EYELIDS PRURITUS
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
METAMORPHOPSIA
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RETINAL DEGENERATION
Eye disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0003 affected3 at risk
EG0012 affected3 at risk
EG0022 affected3 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0022 affected3 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
STOMATITIS
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GASTRITIS
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ASCITES
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DIVERTICULUM
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EPIGASTRIC DISCOMFORT
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ERUCTATION
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HAEMORRHOIDS
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HIATUS HERNIA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LIP ULCERATION
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MELAENA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MOUTH ULCERATION
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
OESOPHAGITIS
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ORAL DYSAESTHESIA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ORAL PAIN
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
REFLUX GASTRITIS
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RETCHING
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SENSITIVITY OF TEETH
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ENLARGED UVULA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOAESTHESIA ORAL
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ANAL FISSURE
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GASTROINTESTINAL DISORDER
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GASTROINTESTINAL INFLAMMATION
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GLOSSITIS
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LOWER GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NEUROGENIC BOWEL
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ORAL DISCOMFORT
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ORAL MUCOSAL ERYTHEMA
Gastrointestinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FATIGUE
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0003 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0023 affected3 at risk
EG003
PYREXIA
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
ASTHENIA
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CHILLS
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FACE OEDEMA
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CHEST PAIN
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GAIT DISTURBANCE
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HERNIA PAIN
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LOCAL SWELLING
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MALAISE
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MUCOSAL INFLAMMATION
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PAIN
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
THROMBOSIS IN DEVICE
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FACIAL PAIN
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GENERALISED OEDEMA
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PERFORMANCE STATUS DECREASED
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
EARLY SATIETY
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
INFLAMMATION
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MUCOSAL DRYNESS
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NODULE
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TEMPERATURE INTOLERANCE
General disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPERBILIRUBINAEMIA
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HEPATIC CIRRHOSIS
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
JAUNDICE
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HEPATITIS
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PORTAL HYPERTENSION
Hepatobiliary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DRUG HYPERSENSITIVITY
Immune system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
CELLULITIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
BACTERIAL INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BODY TINEA
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ENTEROCOCCAL BACTERAEMIA
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LUNG INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
OESOPHAGEAL INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ORAL FUNGAL INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RASH PUSTULAR
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SINUSITIS BACTERIAL
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SKIN INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
STAPHYLOCOCCAL INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TINEA CRURIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
WOUND INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DEVICE RELATED INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PARONYCHIA
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RASH PUSTULAR
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BACTERIAL VAGINOSIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CATHETER SITE INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FURUNCLE
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HERPES VIRUS INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LARYNGITIS VIRAL
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LOCALISED INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NAIL INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ORAL INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PNEUMONIA FUNGAL
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VAGINAL INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CERVICAL VERTEBRAL FRACTURE
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
INCISION SITE ERYTHEMA
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
POST PROCEDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TOOTH FRACTURE
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
BLOOD CREATININE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
EJECTION FRACTION DECREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
WEIGHT DECREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LYMPHOCYTE COUNT DECREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD CHOLESTEROL INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD POTASSIUM DECREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD UREA INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD URINE PRESENT
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HAEMOGLOBIN DECREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
INTERNATIONAL NORMALISED RATIO INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
INTRAOCULAR PRESSURE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PLATELET COUNT DECREASED
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
URINE OUTPUT DECREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
WEIGHT INCREASED
Injury, poisoning and procedural complications
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HEART RATE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VITAMIN D DECREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BLOOD TESTOSTERONE DECREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BREATH SOUNDS ABNORMAL
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ELECTROCARDIOGRAM QT PROLONGED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LIPASE INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PROTHROMBIN TIME PROLONGED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TRANSAMINASES INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TROPONIN INCREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
WHITE BLOOD CELL COUNT DECREASED
Investigations
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOKALAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0022 affected3 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
HYPONATRAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
HYPOMAGNESAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOPHOSPHATAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOALBUMINAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOCALCAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FLUID RETENTION
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
HYPERKALAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FAILURE TO THRIVE
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FLUID OVERLOAD
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
HYPERTRIGLYCERIDAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPERAMYLASAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOVOLAEMIA
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MALNUTRITION
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ARTHROPATHY
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
JOINT EFFUSION
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MUSCULAR WEAKNESS
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Metabolism and nutrition disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BONE PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
GROIN PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MUSCLE TWITCHING
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MUSCULOSKELETAL STIFFNESS
Musculoskeletal and connective tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ACROCHORDON
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LIPOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TUMOUR HAEMORRHAGE
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TUMOUR PAIN
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
INFECTED NEOPLASM
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ONCOLOGIC COMPLICATION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SOMNOLENCE
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
COGNITIVE DISORDER
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NEUROPATHY PERIPHERAL
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TREMOR
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
ATAXIA
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BRAIN OEDEMA
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DEPRESSED LEVEL OF CONSCIOUSNESS
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DIZZINESS EXERTIONAL
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
HEMIANOPIA
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOAESTHESIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MEMORY IMPAIRMENT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PARAESTHESIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PERONEAL NERVE PALSY
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SPINAL CORD COMPRESSION
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
TRANSVERSE SINUS THROMBOSIS
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VISUAL FIELD DEFECT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BALANCE DISORDER
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PARAPLEGIA
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BURNING SENSATION
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DYSARTHRIA
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOKINESIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NEURALGIA
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SCIATICA
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SINUS HEADACHE
Nervous system disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
CONFUSIONAL STATE
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
AGITATION
Pregnancy, puerperium and perinatal conditions
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DEPRESSED MOOD
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DEPRESSIVE SYMPTOM
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DELIRIUM
Psychiatric disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MAJOR DEPRESSION
Pregnancy, puerperium and perinatal conditions
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MENTAL STATUS CHANGES
Pregnancy, puerperium and perinatal conditions
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ACUTE KIDNEY INJURY
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
NOCTURIA
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CHROMATURIA
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
MICTURITION URGENCY
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NEUROGENIC BLADDER
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
POLYURIA
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RENAL FAILURE
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
URINARY TRACT PAIN
Renal and urinary disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BREAST PAIN
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
VAGINAL DISCHARGE
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BREAST MASS
Reproductive system and breast disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PLEURITIC PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PNEUMONITIS
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOXIA
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LUNG INFILTRATION
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SPUTUM INCREASED
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
TACHYPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HAEMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PULMONARY CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PULMONARY HAEMORRHAGE
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DERMATITIS ACNEIFORM
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0003 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG003
PRURITUS GENERALISED
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0022 affected3 at risk
EG003
SKIN DISORDER
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ACTINIC KERATOSIS
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DERMATITIS EXFOLIATIVE
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
GENERALISED ERYTHEMA
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HAIR COLOUR CHANGES
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HAIR GROWTH ABNORMAL
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPERHIDROSIS
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PAIN OF SKIN
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PETECHIAE
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG003
RASH ERYTHEMATOUS
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RASH PRURITIC
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SKIN LESION
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SKIN ULCER
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SKIN BURNING SENSATION
Respiratory, thoracic and mediastinal disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DECUBITUS ULCER
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RASH GENERALISED
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SKIN FISSURES
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
NAIL DISCOLOURATION
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PHOTOSENSITIVITY REACTION
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SKIN DISCOLOURATION
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SKIN EXFOLIATION
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPERTENSION
Skin and subcutaneous tissue disorders
MedDRA (18.0)
Non-systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
DEEP VEIN THROMBOSIS
Surgical and medical procedures
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
FLUSHING
Surgical and medical procedures
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HOT FLUSH
Surgical and medical procedures
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
HYPOTENSION
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
ORTHOSTATIC HYPOTENSION
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
SUPERIOR VENA CAVA SYNDROME
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
CAPILLARY LEAK SYNDROME
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
LYMPHOEDEMA
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
PHLEBITIS SUPERFICIAL
Vascular disorders
MedDRA (18.0)
Non-systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Merck KGaA Communication Center
Merck Serono, a business of Merck KGaA, Darmstadt, Germany
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG006
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG007
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG008
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG009
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG010
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
3
OG0042
OG0053
OG00611
OG00711
OG0082
OG0093
OG0104
0
OG0040
OG0050
OG0060
OG0072
OG0081
OG0092
OG0101
OG002
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG003
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG004
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG005
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG006
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG007
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG008
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG009
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG010
MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG011
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG012
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG013
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG014
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0044
OG0053
OG00619
OG00714
OG0083
OG0093
OG0104
OG01126
OG01224
OG01318
OG01415
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0023
OG0034
OG0044
OG0053
OG00619
OG00714
OG0083
OG0093
OG0104
OG01126
OG01224
OG01318
OG01415
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00110
OG00226
OG00314
OG0044
OG0053
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 10, 26, 13, 4, 3, 25, 23, 18, 15)
Title
Measurements
OG00086.06(51.31 to 144.3)
OG001188.2(138.5 to 255.9)
OG002246.1(191.8 to 315.6)
OG003406.9(284.6 to 581.7)
OG00483.72(18.05 to 388.3)
OG005232.5(190.9 to 283.2)
OG006323.1(253.9 to 411.1)
OG007295.4(240.9 to 362.2)
OG008245.6(198.5 to 304.0)
OG009234.0(182.6 to 299.8)
Day 15 (n=6, 9,15,9, 3, 1, 16, 17, 13, 10)
Title
Measurements
OG000131.3(85.13 to 202.6)
OG001212.8(178.9 to 253.1)
OG002234.2(166.2 to 330.1)
OG003
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00110
OG00226
OG00314
OG0044
OG0053
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n= 6, 10, 25, 13, 4, 3, 25, 23, 18, 15 )
Title
Measurements
OG0001.750(0.50 to 2.08)
OG0010.765(0.50 to 2.15)
OG0022.020(0.50 to 8.05)
OG0031.500(0.50 to 3.00)
OG0041.485(0.50 to 2.08)
OG0051.550(0.50 to 2.07)
OG0061.500(0.50 to 7.90)
OG0071.520(0.50 to 7.85)
OG0081.490(0.50 to 4.20)
OG0091.050(0.45 to 4.00)
Day 15 (n= 6, 9, 15, 9, 3, 1, 16, 17, 13, 10)
Title
Measurements
OG0001.275(0.50 to 3.07)
OG0011.000(1.00 to 1.63)
OG0022.000(1.00 to 7.95)
OG003
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00110
OG00226
OG00314
OG0044
OG0053
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 10, 25, 13, 4, 3, 25, 23, 18, 15)
Title
Measurements
OG000426.8(306.2 to 594.9)
OG001734.4(586.1 to 920.3)
OG0021547(1238 to 1934)
OG0032116(1664 to 2692)
OG004326.1(110.9 to 958.7)
OG0051252(1100 to 1425)
OG0061781(1404 to 2260)
OG0071754(1480 to 2078)
OG0081709(1361 to 2146)
OG0091093(871.5 to 1371)
Day 15 (n=6, 9,15,9, 3, 1, 16, 17, 10, 13)
Title
Measurements
OG000625.3(405.7 to 963.9)
OG001902.0(747.6 to 1088)
OG0021617(1170 to 2236)
OG003
OG002
Pimasertib (MSC1936369B) 60mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG0019
OG00223
OG00313
OG0043
OG0050
OG00622
OG00722
OG00814
OG00913
Title
Denominators
Categories
Title
Measurements
OG000451.6(319.8 to 637.8)
OG001770.9(599.9 to 990.6)
OG0021607(1237 to 2087)
OG0032202(1716 to 2826)
OG004503.1(153.1 to 1654)
OG0061869(1451 to 2407)
OG0071830(1518 to 2207)
OG0081857(1414 to 2437)
OG0091113(858.9 to 1442)
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00110
OG00226
OG00314
OG0044
OG0053
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n= 6, 10, 26, 13, 3, 3, 24, 23, 17,13)
Title
Measurements
OG000426.8(306.2 to 594.9)
OG001742.1(602.0 to 914.7)
OG0021547(1238 to 1934)
OG0032116(1664 to 2692)
OG004354.9(48.21 to 2613)
OG0051252(1100 to 1425)
OG0061882(1513 to 2341)
OG0071754(1480 to 2078)
OG0081772(1409 to 2227)
OG0091093(871.5 to 1371)
Day 15 (n=6, 9, 15, 9, 3, 0, 16, 17, 10, 13)
Title
Measurements
OG000650.4(440.1 to 961.2)
OG001902.0(747.6 to 1088)
OG0021617(1170 to 2236)
OG003
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00110
OG00226
OG00314
OG0044
OG0053
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 9, 23, 13, 4, 3, 22, 22, 15, 13)
Title
Measurements
OG0006.250(5.03 to 7.16)
OG0014.670(1.85 to 5.79)
OG0024.840(3.23 to 9.99)
OG0034.800(3.49 to 7.62)
OG0043.320(2.60 to 4.72)
OG0054.640(4.25 to 4.74)
OG0064.840(2.46 to 8.41)
OG0074.370(3.71 to 8.26)
OG0084.770(3.51 to 12.8)
OG0094.240(3.32 to 4.84)
Day 15 (n=6, 9, 14, 9, 2, 1, 16, 16, 9, 12)
Title
Measurements
OG0005.855(2.93 to 7.88)
OG0015.410(3.90 to 10.8)
OG0026.755(4.61 to 14.3)
OG003
OG002
Pimasertib (MSC1936369B) 60mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00110
OG00226
OG00314
OG0044
OG0051
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 10, 26, 13, 3, 0, 22, 22, 14, 13)
Title
Measurements
OG00033.22(23.52 to 46.92)
OG00138.90(30.26 to 50.00)
OG00237.99(29.33 to 49.22)
OG00340.88(31.85 to 52.47)
OG00489.49(27.14 to 295.1)
OG005NA(NA to NA)Data could not be calculated because there were no subjects evaluated for this arm at the specified time point.
OG00632.12(24.95 to 41.36)
OG00732.75(27.16 to 39.50)
OG00830.75(23.41 to 40.41)
OG00953.94(41.61 to 69.62)
Day 15 (n=6, 9, 15, 9, 3, 1, 16, 17, 10, 13)
Title
Measurements
OG00023.06(15.59 to 34.10)
OG00133.30(27.63 to 40.13)
OG00237.11(26.82 to 51.33)
OG003
OG001
Pimasertib (MSC1936369B) 30mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
Pimasertib (MSC1936369B) 60mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00110
OG00226
OG00314
OG0043
OG0050
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 9, 23, 13, 3, 0, 22, 22, 14, 13)
Title
Measurements
OG000294.3(218.5 to 396.4)
OG001240.2(202.5 to 284.9)
OG002282.8(227.7 to 351.4)
OG003283.0(224.0 to 357.6)
OG004394.1(146.9 to 1058)
OG006223.8(182.7 to 274.3)
OG007226.9(193.9 to 265.4)
OG008216.2(174.6 to 267.8)
OG009322.0(251.5 to 412.3)
Day 15 (n=6, 9, 13, 9, 0, 0, 16, 16, 9, 12)
Title
Measurements
OG000188.7(133.4 to 266.9)
OG001261.8(187.9 to 364.8)
OG002396.4(276.9 to 567.3)
OG003
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG0019
OG00215
OG0039
OG0043
OG0051
OG00615
OG00717
OG00810
OG00913
Title
Denominators
Categories
Title
Measurements
OG0001.523(1.295 to 1.792)
OG0011.269(1.107 to 1.455)
OG0021.174(0.9326 to 1.479)
OG0031.364(1.133 to 1.642)
OG0042.176(0.1184 to 39.99)
OG005NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0061.368(1.044 to 1.792)
OG0071.155(1.004 to 1.330)
OG0081.245(0.9538 to 1.625)
OG0091.283(1.104 to 1.490)
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
Pimasertib (MSC1936369B) 90mg
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
Pimasertib (MSC1936369B) 45mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
Pimasertib (MSC1936369B) 60mg Twice Daily
Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: Pimasertib 60mg Once Daily
Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG0019
OG00215
OG0039
OG0043
OG0051
OG00616
OG00717
OG00810
OG00913
Title
Denominators
Categories
Title
Measurements
OG0001.525(1.002 to 2.322)
OG0011.066(0.7442 to 1.527)
OG0021.106(0.7904 to 1.546)
OG0031.308(0.7537 to 2.268)
OG0041.467(0.02541 to 84.67)
OG005NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0061.203(0.9074 to 1.595)
OG0071.059(0.8875 to 1.263)
OG0081.247(0.8719 to 1.784)
OG0091.393(1.091 to 1.780)
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00111
OG00236
OG0033
OG0043
OG0054
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)
Title
Measurements
OG000192.0(115.6 to 316.3)
OG001295.7(189.0 to 462.6)
OG002256.9(203.5 to 324.3)
OG003224.5(99.72 to 505.2)
OG004130.2(20.76 to 816.5)
OG00564.22(19.25 to 214.2)
OG006323.6(258.4 to 405.2)
OG007240.6(164.6 to 351.6)
OG008239.6(158.8 to 361.4)
OG009212.5(129.3 to 349.4)
Day 15 (n=6, 6, 25, 1, 1, 3, 17, 17, 10, 13)
Title
Measurements
OG000199.8(114.4 to 349.1)
OG001224.1(132.7 to 378.4)
OG002222.9(143.7 to 345.7)
OG003
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00111
OG00236
OG0033
OG0043
OG0054
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)
Title
Measurements
OG0001.510(0.53 to 2.08)
OG0011.150(0.50 to 4.10)
OG0021.500(0.50 to 23.80)
OG0031.500(1.00 to 8.00)
OG0042.050(1.50 to 2.07)
OG0051.540(0.50 to 4.00)
OG0061.500(0.52 to 8.03)
OG0072.000(0.50 to 4.17)
OG0082.000(0.43 to 8.05)
OG0091.500(0.95 to 4.00)
Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
Title
Measurements
OG0001.265(1.00 to 2.00)
OG0011.750(0.53 to 3.00)
OG0021.970(1.00 to 8.13)
OG003
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00111
OG00236
OG0033
OG0043
OG0054
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 11, 36, 3, 3, 4, 26, 23, 18, 15)
Title
Measurements
OG000683.6(248.9 to 1878)
OG0011248(760.1 to 2050)
OG0021566(1162 to 2111)
OG0033032(1425 to 6454)
OG004634.0(111.8 to 3595)
OG005226.2(82.99 to 616.7)
OG0061976(1449 to 2693)
OG0071408(962.5 to 2059)
OG0081479(824.6 to 2653)
OG009854.9(505.0 to 1447)
Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
Title
Measurements
OG000861.0(371.5 to 1995)
OG0011125(558.3 to 2266)
OG0021334(895.8 to 1986)
OG003
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00111
OG00236
OG0033
OG0043
OG0054
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 11, 36, 3, 3, 3, 24, 23, 17, 15)
Title
Measurements
OG000746.9(275.5 to 2024)
OG0011265(784.5 to 2041)
OG0021601(1195 to 2145)
OG0033032(1425 to 6454)
OG004634.0(111.8 to 3595)
OG005298.6(120.4 to 740.6)
OG0062115(1535 to 2915)
OG0071480(1026 to 2137)
OG0081542(851.5 to 2792)
OG009948.4(601.8 to 1495)
Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
Title
Measurements
OG000887.9(397.9 to 1981)
OG0011168(611.5 to 2232)
OG0021362(918.9 to 2018)
OG003
OG002
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0005
OG0019
OG00231
OG0032
OG0041
OG0053
OG00620
OG00717
OG00812
OG00912
Title
Denominators
Categories
Title
Measurements
OG000716.5(181.8 to 2823)
OG0011165(648.3 to 2093)
OG0021504(1113 to 2034)
OG003NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG005331.2(151.5 to 724.1)
OG0061974(1408 to 2768)
OG0071445(1019 to 2049)
OG0081261(579.4 to 2743)
OG0091142(750.4 to 1739)
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00111
OG00236
OG0033
OG0043
OG0054
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=6, 9, 31, 2, 2, 3, 20, 19, 13, 14)
Title
Measurements
OG0003.055(1.78 to 7.57)
OG0013.300(1.45 to 8.94)
OG0023.390(0.964 to 9.28)
OG003NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0053.310(2.47 to 3.37)
OG0063.755(1.32 to 7.59)
OG0073.300(2.54 to 27.9)
OG0084.070(2.14 to 9.02)
OG0093.120(1.32 to 6.03)
Day 15 (n=6, 8, 22, 1, 1, 2, 10, 15, 8, 10)
Title
Measurements
OG0003.700(2.07 to 5.60)
OG0014.570(1.81 to 6.49)
OG0024.560(2.37 to 35.2)
OG003
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00111
OG00236
OG0032
OG0041
OG0054
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=5, 9, 31, 2, 1, 3, 20, 17, 12, 12)
Title
Measurements
OG00041.80(10.62 to 164.5)
OG00142.93(23.89 to 77.16)
OG00246.54(34.42 to 62.94)
OG003NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG005151.4(69.37 to 330.4)
OG00635.43(25.26 to 49.69)
OG00748.40(34.12 to 68.64)
OG00855.51(25.52 to 120.7)
OG00961.29(40.26 to 93.30)
Day 15 (n=6, 8, 25, 1, 1, 3, 17, 17, 10, 13)
Title
Measurements
OG00033.78(15.16 to 75.26)
OG00142.81(22.39 to 81.85)
OG00251.38(34.68 to 76.13)
OG003
SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
SAR245409 70mg
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG00111
OG00236
OG0032
OG0041
OG0054
OG00626
OG00724
OG00818
OG00915
Title
Denominators
Categories
Day 1 (n=5, 9, 31, 2, 1, 3, 20, 17, 12, 12)
Title
Measurements
OG000174.8(71.24 to 429.0)
OG001223.4(116.2 to 429.6)
OG002238.5(179.0 to 317.8)
OG003NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG005658.0(211.9 to 2044)
OG006175.2(123.9 to 247.9)
OG007251.4(158.4 to 398.9)
OG008353.6(177.1 to 705.8)
OG009270.3(175.6 to 416.0)
Day 15 (n=6, 8, 25, 1, 1, 2, 17, 17, 10, 13 )
Title
Measurements
OG000165.7(99.48 to 276.1)
OG001257.2(156.7 to 422.1)
OG002355.9(212.5 to 596.2)
OG003
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG0018
OG00225
OG0031
OG0041
OG0053
OG00615
OG00717
OG00810
OG00913
Title
Denominators
Categories
Title
Measurements
OG0001.189(0.6118 to 2.311)
OG0011.004(0.4637 to 2.175)
OG0020.9450(0.6749 to 1.323)
OG003NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0051.800(0.1724 to 18.79)
OG0061.256(0.9407 to 1.676)
OG0070.9887(0.7202 to 1.357)
OG0081.187(0.7614 to 1.850)
OG0091.022(0.6346 to 1.645)
OG003
SAR245409 90mg
SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
SAR245409 30mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
SAR245409 50mg Twice Daily
SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
TNBC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG007
NSCLC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG008
CRC: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG009
MEL: SAR245409 70mg Once Daily
SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0006
OG0018
OG00225
OG0031
OG0041
OG0053
OG00617
OG00717
OG00810
OG00913
Title
Denominators
Categories
Title
Measurements
OG0001.041(0.6293 to 1.722)
OG0010.8133(0.3484 to 1.898)
OG0020.8962(0.6151 to 1.306)
OG003NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0051.336(0.03347 to 53.32)
OG0061.070(0.8319 to 1.375)
OG0070.8950(0.6951 to 1.152)
OG0080.9611(0.6441 to 1.434)
OG0090.9942(0.5447 to 1.815)
OG001
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG002
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG003
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG004
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject
OG005
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG006
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0041
OG0053
OG0061
Title
Denominators
Categories
DDI Day 1: Pre-dose (n= 1, 0, 0, 0, 0, 0, 1)
Title
Measurements
OG00061.02± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00633.78± NAData for standard deviation was not estimable as only one subject analyzed.
DDI Day 1: 2hr post-dose (n= 1,0,0,0,0,0,1)
Title
Measurements
OG00036.15± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 1: 4hr post-dose (n= 1,0,0,0,0,0,1)
Title
Measurements
OG00089.14± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 1: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)
Title
Measurements
OG00054.54± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 1: 24hr post-dose (n= 1,0,0,0,0,0,0)
Title
Measurements
OG00088.80± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 2: 24hr post-dose (n= 0,0,0,0,0,0,1)
Title
Measurements
OG000NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 3: Pre-dose (n= 1, 0, 0, 0, 0, 0, 1)
Title
Measurements
OG00057.51± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 3: 2hr post-dose (n= 1,0,0,0,0,0,1)
Title
Measurements
OG00055.93± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 3: 4hr post-dose (n= 1,0,0,0,0,0,1)
Title
Measurements
OG00036.76± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0001.08± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI:Day 3: 24hr post-dose (n= 1,0,0,0,0,0,0)
Title
Measurements
OG00087.60± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 4: 24hr post-dose (n= 0,0,0,0,0,0,1)
Title
Measurements
OG000NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
C1D1: Pre dose (n= 1,1,1,1,1,1,1)
Title
Measurements
OG00051.32± NAData for standard deviation was not estimable as only one subject analyzed.
OG00183.52± NAData for standard deviation was not estimable as only one subject analyzed.
OG00296.98± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D1: 2hr postdose (n= 1,1,1,1,1,1,1)
Title
Measurements
OG00031.08± NAData for standard deviation was not estimable as only one subject analyzed.
OG00124.48± NAData for standard deviation was not estimable as only one subject analyzed.
OG00256.41± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D1: 4hr postdose (n= 1,1,1,1,1,1,1)
Title
Measurements
OG00025.71± NAData for standard deviation was not estimable as only one subject analyzed.
OG00146.95± NAData for standard deviation was not estimable as only one subject analyzed.
OG00250.11± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D1: 8hr postdose (n= 1,1,1,1,1,1,1)
Title
Measurements
OG0003.02± NAData for standard deviation was not estimable as only one subject analyzed.
OG0011.28± NAData for standard deviation was not estimable as only one subject analyzed.
OG00284.57± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D1: 24hr postdose(n= 1,1,1,1,0,0,0)
Title
Measurements
OG00046.16± NAData for standard deviation was not estimable as only one subject analyzed.
OG00172.14± NAData for standard deviation was not estimable as only one subject analyzed.
OG00274.15± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D2: 24hr postdose (n= 0,0,0,0,1,1,1)
Title
Measurements
OG000NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
C1D15: pre-dose (n= 1,1,1,1,1,0,1)
Title
Measurements
OG00043.48± NAData for standard deviation was not estimable as only one subject analyzed.
OG00181.29± NAData for standard deviation was not estimable as only one subject analyzed.
OG00267.69± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D15: 2hr postdose (n= 1,1,1,1,1,0,1)
Title
Measurements
OG00026.41± NAData for standard deviation was not estimable as only one subject analyzed.
OG00143.70± NAData for standard deviation was not estimable as only one subject analyzed.
OG00248.23± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D15: 4hr postdose (n= 1,1,1,1,1,0,1)
Title
Measurements
OG00041.34± NAData for standard deviation was not estimable as only one subject analyzed.
OG00153.37± NAData for standard deviation was not estimable as only one subject analyzed.
OG00292.67± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D15: 8hr postdose (n= 1,1,1,1,1,0,1)
Title
Measurements
OG0000.53± NAData for standard deviation was not estimable as only one subject analyzed.
OG00145.97± NAData for standard deviation was not estimable as only one subject analyzed.
OG00277.62± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D15: 24hr postdose (n= 1,1,1,1,0,0,0)
Title
Measurements
OG00069.93± NAData for standard deviation was not estimable as only one subject analyzed.
OG0010.76± NAData for standard deviation was not estimable as only one subject analyzed.
OG002114.39± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D16: 24hr postdose (n= 0,0,0,0,1,0,1)
Title
Measurements
OG000NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
C1D19: pre-dose (n= 1,1,1,1,1,0,1)
Title
Measurements
OG00068.48± NAData for standard deviation was not estimable as only one subject analyzed.
OG00190.02± NAData for standard deviation was not estimable as only one subject analyzed.
OG002125.77± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D19: 2hr postdose (n= 1,0,0,0,0,0,0)
Title
Measurements
OG0004.34± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG001
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG002
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG003
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG004
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject
OG005
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
OG006
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.
Units
Counts
Participants
OG0001
OG0011
OG0021
OG0031
OG0041
OG0053
OG0061
Title
Denominators
Categories
DDI Day 1: Predose (n= 1, 0, 0, 0, 0, 0, 1)
Title
Measurements
OG0006.77± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00610.55± NAData for standard deviation was not estimable as only one subject analyzed.
DDI Day 1: 2 hr post-dose (n=1,0,0,0,0.0,1)
Title
Measurements
OG0008.74± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 1: 4 hr post-dose ((n=1,0,0,0,0,0,1)
Title
Measurements
OG0006.10± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 1: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)
Title
Measurements
OG0007.42± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 1: 24 hr post-dose (n=1,0,0,0,0,0,0)
Title
Measurements
OG00010.84± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 2: 24 hr post-dose ((n= 0,0,0,0,0,0,1)
Title
Measurements
OG000NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 3: Pre-dose (n= 1, 0, 0, 0, 0, 0, 1)
Title
Measurements
OG0009.46± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 3: 2 hr post-dose (n=1,0,0,0,0,0,1)
Title
Measurements
OG0003.12± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 3: 4 hr post-dose (n-1,0,0,0,0,0,1)
Title
Measurements
OG0006.74± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 3: 8 hr post-dose(n= 1, 0, 0, 0, 0, 0, 1)
Title
Measurements
OG0000.81± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 3: 24 hr post-dose (n=1,0,0,0,0,0,0)
Title
Measurements
OG0006.18± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
DDI Day 4: 24 hr post-dose (n=0,0,0,0,0,0,1)
Title
Measurements
OG000NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
C1D1: Pre dose (n=1,1,1,1,1,1,1)
Title
Measurements
OG0005.56± NAData for standard deviation was not estimable as only one subject analyzed.
OG0013.45± NAData for standard deviation was not estimable as only one subject analyzed.
OG0026.96± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D1: 2hr postdose(n= 1,1,1,1,1,1,1)
Title
Measurements
OG0002.37± NAData for standard deviation was not estimable as only one subject analyzed.
OG0011.33± NAData for standard deviation was not estimable as only one subject analyzed.
OG0022.78± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D1: 4hr postdose(n= 1,1,1,1,1,1,1)
Title
Measurements
OG0002.85± NAData for standard deviation was not estimable as only one subject analyzed.
OG0011.37± NAData for standard deviation was not estimable as only one subject analyzed.
OG0022.91± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D1: 8hr postdose(n= 1,1,1,1,1,1,1)
Title
Measurements
OG0000.67± NAData for standard deviation was not estimable as only one subject analyzed.
OG0010.94± NAData for standard deviation was not estimable as only one subject analyzed.
OG0023.40± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D1: 24hr postdose(n= 1,1,1,1,0,0,0)
Title
Measurements
OG0006.23± NAData for standard deviation was not estimable as only one subject analyzed.
OG0012.15± NAData for standard deviation was not estimable as only one subject analyzed.
OG0024.59± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D2: 24hr postdose(n= 0,0,0,0,1,1,1)
Title
Measurements
OG000NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
C1D15: pre-dose(n= 1,1,1,1,1,0,1)
Title
Measurements
OG0003.79± NAData for standard deviation was not estimable as only one subject analyzed.
OG0012.26± NAData for standard deviation was not estimable as only one subject analyzed.
OG0025.29± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D15: 2hr postdose (n= 1,1,1,1,1,0,1)
Title
Measurements
OG0002.16± NAData for standard deviation was not estimable as only one subject analyzed.
OG0011.34± NAData for standard deviation was not estimable as only one subject analyzed.
OG0022.83± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D15: 4hr postdose (n= 1,1,1,1,1,0,1)
Title
Measurements
OG0001.87± NAData for standard deviation was not estimable as only one subject analyzed.
OG0011.34± NAData for standard deviation was not estimable as only one subject analyzed.
OG0022.50± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D15: 8hr postdose (n= 1,1,1,1,1,0,1)
Title
Measurements
OG0001.92± NAData for standard deviation was not estimable as only one subject analyzed.
OG0012.08± NAData for standard deviation was not estimable as only one subject analyzed.
OG0023.38± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D15: 24hr postdose (n= 1,1,1,1,0,0,0)
Title
Measurements
OG0004.97± NAData for standard deviation was not estimable as only one subject analyzed.
OG0010.94± NAData for standard deviation was not estimable as only one subject analyzed.
OG0025.33± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D16: 24hr postdose (n= 0,0,0,0,1,0,1)
Title
Measurements
OG000NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
C1D19: pre-dose (n= 1,1,1,1,1,0,1)
Title
Measurements
OG0006.54± NAData for standard deviation was not estimable as only one subject analyzed.
OG0012.61± NAData for standard deviation was not estimable as only one subject analyzed.
OG0024.47± NAData for standard deviation was not estimable as only one subject analyzed.
OG003
C1D19: 2hr postdose (n= 1,0,0,0,0,0,0)
Title
Measurements
OG0001.60± NAData for standard deviation was not estimable as only one subject analyzed.
OG001NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG002NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG002
Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG003
Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG004
Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG005
Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG006
Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG007
Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG008
Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily
Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG009
Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG010
Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily
Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
OG011
TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG012
NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG013
CRC: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
OG014
MEL: Pimasertib 60mg and SAR245409 70mg Once Daily
Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0034
OG0044
OG0052
OG00613
OG00711
OG0082
OG0091
OG0103
OG01116
OG01220
OG01311
OG01414
Title
Denominators
Categories
Stable disease
Title
Measurements
OG0003
OG0012
OG0022
OG0033
OG0041
OG0052
OG0064
OG0076
OG0080
OG0091
OG0102
OG0117
OG01210
OG0131
OG0147
Progressive disease
Title
Measurements
OG0000
OG0010
OG0021
OG003
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Partial Response
Title
Measurements
OG0000
OG0011
OG0020
OG003
Not Evaluable
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 affected
4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0061 affected19 at risk
EG0071 affected14 at risk
EG0081 affected3 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0132 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0061 affected19 at risk
EG0070 affected14 at risk
EG0081 affected3 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0132 affected18 at risk
EG0141 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0061 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0061 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0131 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0061 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0102 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0132 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0051 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0064 affected19 at risk
EG0073 affected14 at risk
EG0080 affected3 at risk
EG0091 affected3 at risk
EG0101 affected4 at risk
EG0112 affected26 at risk
EG0121 affected24 at risk
EG0132 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0064 affected19 at risk
EG0071 affected14 at risk
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EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0124 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0131 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0141 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0131 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0131 affected18 at risk
EG0140 affected15 at risk
2 affected
4 at risk
EG0040 affected4 at risk
EG0052 affected3 at risk
EG0069 affected19 at risk
EG0076 affected14 at risk
EG0081 affected3 at risk
EG0092 affected3 at risk
EG0101 affected4 at risk
EG01113 affected26 at risk
EG0128 affected24 at risk
EG0134 affected18 at risk
EG0147 affected15 at risk
2 affected
4 at risk
EG0043 affected4 at risk
EG0050 affected3 at risk
EG0066 affected19 at risk
EG0075 affected14 at risk
EG0081 affected3 at risk
EG0092 affected3 at risk
EG0103 affected4 at risk
EG0116 affected26 at risk
EG01212 affected24 at risk
EG0134 affected18 at risk
EG0145 affected15 at risk
1 affected
4 at risk
EG0042 affected4 at risk
EG0050 affected3 at risk
EG0062 affected19 at risk
EG0073 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0115 affected26 at risk
EG0125 affected24 at risk
EG0131 affected18 at risk
EG0145 affected15 at risk
1 affected
4 at risk
EG0041 affected4 at risk
EG0051 affected3 at risk
EG0061 affected19 at risk
EG0073 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0112 affected26 at risk
EG0122 affected24 at risk
EG0130 affected18 at risk
EG0143 affected15 at risk
1 affected
4 at risk
EG0041 affected4 at risk
EG0051 affected3 at risk
EG0061 affected19 at risk
EG0073 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0112 affected26 at risk
EG0122 affected24 at risk
EG0130 affected18 at risk
EG0143 affected15 at risk
2 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0062 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0112 affected26 at risk
EG0120 affected24 at risk
EG0131 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0062 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0112 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0061 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
1 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0061 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
1 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0141 affected15 at risk
0 affected
4 at risk
EG0041 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0131 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0041 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0081 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0041 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
1 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0091 affected3 at risk
EG0100 affected4 at risk
EG0112 affected26 at risk
EG0120 affected24 at risk
EG0131 affected18 at risk
EG0141 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0112 affected26 at risk
EG0120 affected24 at risk
EG0131 affected18 at risk
EG0141 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0112 affected26 at risk
EG0120 affected24 at risk
EG0131 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0122 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0112 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0141 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0141 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0141 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0063 affected19 at risk
EG0070 affected14 at risk
EG0083 affected3 at risk
EG0090 affected3 at risk
EG0101 affected4 at risk
EG0113 affected26 at risk
EG0123 affected24 at risk
EG0131 affected18 at risk
EG0145 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0081 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0112 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0071 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0081 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0113 affected26 at risk
EG0122 affected24 at risk
EG0130 affected18 at risk
EG0141 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0051 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0121 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0111 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0140 affected15 at risk
0 affected
4 at risk
EG0040 affected4 at risk
EG0050 affected3 at risk
EG0060 affected19 at risk
EG0070 affected14 at risk
EG0080 affected3 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected26 at risk
EG0120 affected24 at risk
EG0130 affected18 at risk
EG0141 affected15 at risk
516.4
(375.0 to 711.0)
OG004143.1(22.82 to 897.8)
OG005NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG006320.5(286.2 to 358.9)
OG007327.6(248.5 to 431.9)
OG008307.7(205.0 to 461.8)
OG009338.9(281.0 to 408.8)
1.550
(1.00 to 2.00)
OG0042.000(1.50 to 4.17)
OG005NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0061.505(0.53 to 3.00)
OG0071.530(1.00 to 4.00)
OG0081.500(0.50 to 8.00)
OG0091.030(0.48 to 3.83)
2552
(2185 to 2980)
OG004773.1(201.0 to 2974)
OG005NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0062136(1713 to 2663)
OG0071889(1540 to 2318)
OG0081988(1487 to 2658)
OG0091506(1141 to 1988)
2552
(2185 to 2980)
OG004773.1(201.0 to 2974)
OG005NA(NA to NA)Data could not be calculated because there were no subjects evaluated for this arm at the specified time point.
OG0062136(1713 to 2663)
OG0071889(1540 to 2318)
OG0081988(1487 to 2658)
OG0091506(1141 to 1988)
5.590
(3.97 to 14.1)
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG005NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0065.210(3.25 to 12.8)
OG0075.250(4.33 to 8.65)
OG0085.210(4.80 to 6.94)
OG0094.325(3.40 to 5.96)
35.28
(30.19 to 41.23)
OG00458.22(15.03 to 225.6)
OG005NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG00628.11(22.54 to 35.07)
OG00731.73(25.85 to 38.94)
OG00830.20(22.59 to 40.38)
OG00939.81(30.17 to 52.52)
302.4
(223.1 to 409.7)
OG004NA(NA to NA)Data could not be calculated because there were no subjects evaluated for this arm at the specified time point because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of Vz/f.
OG006226.3(189.7 to 270.1)
OG007250.9(214.2 to 293.9)
OG008230.6(169.0 to 314.6)
OG009273.8(213.8 to 350.7)
NA
(NA to NA)
Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG005117.2(7.210 to 1907)
OG006326.0(256.4 to 414.6)
OG007235.5(144.6 to 383.3)
OG008178.9(82.31 to 389.0)
OG009226.6(143.9 to 356.7)
NA
(NA to NA)
Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0051.550(1.50 to 8.00)
OG0062.030(0.52 to 7.98)
OG0071.530(0.92 to 8.00)
OG0081.750(0.50 to 8.00)
OG0091.050(0.50 to 3.97)
NA
(NA to NA)
Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG005537.5(56.10 to 5150)
OG0062232(1512 to 3297)
OG0071437(922.1 to 2239)
OG0081365(543.4 to 3431)
OG009968.8(554.8 to 1692)
NA
(NA to NA)
Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG005537.5(56.10 to 5150)
OG0062390(1696 to 3368)
OG0071437(922.1 to 2239)
OG0081365(543.4 to 3431)
OG0091074(636.9 to 1811)
NA
(NA to NA)
Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG005NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG0062.840(1.48 to 5.63)
OG0074.050(2.74 to 7.87)
OG0086.170(3.43 to 11.8)
OG0093.065(1.79 to 5.37)
NA
(NA to NA)
Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG00592.90(9.667 to 892.8)
OG00629.28(20.78 to 41.26)
OG00748.69(31.25 to 75.88)
OG00851.24(20.38 to 128.8)
OG00965.16(38.64 to 109.9)
NA
(NA to NA)
Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG004NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG005NA(NA to NA)Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.
OG006132.8(96.16 to 183.4)
OG007247.1(149.4 to 410.7)
OG008475.9(128.0 to 1769)
OG009293.4(141.6 to 607.7)
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00629.84± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00630.28± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00644.88± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00628.86± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00614.90± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00634.06± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0061.03± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00640.40± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0061.04± NAData for standard deviation was not estimable as only one subject analyzed.
47.09
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG00450.17± NAData for standard deviation was not estimable as only one subject analyzed.
OG0054.18± NAData for standard deviation was not estimable as only one subject analyzed.
OG00636.03± NAData for standard deviation was not estimable as only one subject analyzed.
23.89
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0045.72± NAData for standard deviation was not estimable as only one subject analyzed.
OG0050.92± NAData for standard deviation was not estimable as only one subject analyzed.
OG0061.04± NAData for standard deviation was not estimable as only one subject analyzed.
29.85
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG00418.21± NAData for standard deviation was not estimable as only one subject analyzed.
OG0050.72± NAData for standard deviation was not estimable as only one subject analyzed.
OG0060.94± NAData for standard deviation was not estimable as only one subject analyzed.
19.75
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0046.21± NAData for standard deviation was not estimable as only one subject analyzed.
OG0051.18± NAData for standard deviation was not estimable as only one subject analyzed.
OG0060.96± NAData for standard deviation was not estimable as only one subject analyzed.
53.47
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00424.66± NAData for standard deviation was not estimable as only one subject analyzed.
OG0051.61± NAData for standard deviation was not estimable as only one subject analyzed.
OG0061.00± NAData for standard deviation was not estimable as only one subject analyzed.
1.20
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG00433.43± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0060.98± NAData for standard deviation was not estimable as only one subject analyzed.
15.02
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG00421.11± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0061.06± NAData for standard deviation was not estimable as only one subject analyzed.
0.96
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG00419.68± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0061.03± NAData for standard deviation was not estimable as only one subject analyzed.
36.06
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG00430.08± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0060.88± NAData for standard deviation was not estimable as only one subject analyzed.
70.46
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00424.36± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0060.98± NAData for standard deviation was not estimable as only one subject analyzed.
82.06
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG00430.58± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00649.62± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00610.17± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0066.50± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0069.36± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0068.32± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0068.94± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00615.82± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0060.68± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG00615.68± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0061.06± NAData for standard deviation was not estimable as only one subject analyzed.
3.25
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0043.35± NAData for standard deviation was not estimable as only one subject analyzed.
OG0051.97± NAData for standard deviation was not estimable as only one subject analyzed.
OG0067.42± NAData for standard deviation was not estimable as only one subject analyzed.
1.54
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0041.40± NAData for standard deviation was not estimable as only one subject analyzed.
OG0050.95± NAData for standard deviation was not estimable as only one subject analyzed.
OG0061.04± NAData for standard deviation was not estimable as only one subject analyzed.
1.24
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0041.96± NAData for standard deviation was not estimable as only one subject analyzed.
OG0051.11± NAData for standard deviation was not estimable as only one subject analyzed.
OG0061.01± NAData for standard deviation was not estimable as only one subject analyzed.
1.96
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0041.27± NAData for standard deviation was not estimable as only one subject analyzed.
OG0051.12± NAData for standard deviation was not estimable as only one subject analyzed.
OG0060.82± NAData for standard deviation was not estimable as only one subject analyzed.
6.26
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0043.45± NAData for standard deviation was not estimable as only one subject analyzed.
OG0051.26± NAData for standard deviation was not estimable as only one subject analyzed.
OG0061.05± NAData for standard deviation was not estimable as only one subject analyzed.
1.41
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0041.93± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0062.03± NAData for standard deviation was not estimable as only one subject analyzed.
1.60
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0041.55± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0060.94± NAData for standard deviation was not estimable as only one subject analyzed.
0.94
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0041.20± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0060.81± NAData for standard deviation was not estimable as only one subject analyzed.
1.10
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0041.74± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0060.99± NAData for standard deviation was not estimable as only one subject analyzed.
4.70
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0042.36± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0060.99± NAData for standard deviation was not estimable as only one subject analyzed.
5.44
± NA
Data for standard deviation was not estimable as only one subject analyzed.
OG0042.07± NAData for standard deviation was not estimable as only one subject analyzed.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG0065.72± NAData for standard deviation was not estimable as only one subject analyzed.
OG003NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG004NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG005NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.
OG006NA± NAThe parameter was not analyzed at specified time point because there were no subjects for which data was collected at the specified time point.