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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003767-63 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available.
Subjects will be assigned one of the dosing regimens:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC2156119J Regimen 1 | Experimental | Subjects will be administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1. |
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| MSC2156119J Regimen 2 | Experimental | Subjects will be administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2. |
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| MSC2156119J Regimen 3 | Experimental | Subjects will be administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC2156119J | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any Dose Limiting Toxicity (DLT) | DLT was defined as one of the following adverse events (AEs) observed during Cycle1, regardless of MSC2156119J relationship, excluding AEs assessed by investigator exclusively related to subject's underlying disease or medical condition: Grade 4 neutropenia for >7 days; Grade >=3 febrile neutropenia for >1 day; Grade 4 thrombocytopenia/Grade 3 with bleeding; Grade >=3 nausea and emesis, despite optimal treatment; Grade >=3 non-hematological AE, except emesis and nausea with no adequate therapy and alopecia, Grade >= 3 liver AE with a recovery period of >7 days or to Grade <=1 for subjects without liver metastases or to <=2 for subjects with liver metastases; Grade >=3 lipase and/or amylase rise with pancreatitis confirmation, either based on clinical or radiological signs. Any AE not otherwise defined as a DLT that, due to prolonged recovery to Grade <=1 or baseline status, leads to delay of above 21 days in planned administration of study drug. | Day 1, 3, 8, 14, 17 of Cycle 1 (for Regimen 1 and 3); Day 1, 3, 8, 15, 19 of Cycle 1 (for Regimen 2) |
| Recommended Phase 2 Dose (RP2D) | MTD was defined as the dose level at which 2 out of 3 subjects or 2 out of 6 subjects experienced a DLT. The primary endpoint was to determine MTD of MSC2156119J for each of the 3 treatment regimens in subjects with advanced solid tumors. However, during the course of the trial it was established that the MTD could not be determined and instead, RP2D was to be determined. | Cycle 1 (Day 1 to Day 21) |
| Number of Subjects With Treatment-Related Adverse Events | Related AE was defined as any untoward medical occurrence which was considered to have a relationship with the study drug (suspected to be reasonably related to the study drug or AE was medically (pharmacologically/clinically) attributed to the study drug as per Investigator's assessment. | Baseline up to 158.01 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment-Emergent AEs (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death | AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs. |
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Inclusion Criteria:
Subject should read and fully understand the requirements of the trial, be willing to comply with all trial visits and assessments, and be willing and able to give informed consent
Histologically or cytologically confirmed solid tumor, either refractory to standard therapy or for which no effective standard therapy is available
Measurable or evaluable disease, as defined by RECIST 1.0
Estimated life expectancy greater than (>) three months
Men or women aged greater than or equal to (>=) 18 years
Women of childbearing potential must have a negative blood pregnancy test at the Screening Visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are post-menopausal for at least 12 months, are surgically sterile, or are sexually inactive.
Subjects and their partners must be willing to avoid pregnancy during the trial and until three months after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator, such as a two-barrier method or one-barrier method with spermicide or intrauterine device. This requirement begins two weeks before receiving the first trial treatment and ends one month after receiving the last treatment.
ECOG performance status of 0 to 2
Adequate hematological function:
Adequate liver function:
For subjects with liver metastases:
Adequate renal function:
Resolution of all acute chemotherapy, radiotherapy or surgery-related AEs to Grade <= 2, except for alopecia
Recovery from any surgical intervention
Subjects enrolling after the MTD has been determined must present specific c Met alterations (mutation, overexpression, amplification
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.D. Anderson Cancer Center | Houston | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31822497 | Result | Falchook GS, Kurzrock R, Amin HM, Xiong W, Fu S, Piha-Paul SA, Janku F, Eskandari G, Catenacci DV, Klevesath M, Bruns R, Stammberger U, Johne A, Bladt F, Friese-Hamim M, Girard P, El Bawab S, Hong DS. First-in-Man Phase I Trial of the Selective MET Inhibitor Tepotinib in Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Mar 15;26(6):1237-1246. doi: 10.1158/1078-0432.CCR-19-2860. Epub 2019 Dec 10. | |
| 35771259 |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
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First/last subject (informed consent): November 2009/December 2014. Last subject completed: October 2015. Clinical data cut-off: February 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | MSC2156119J Regimen 1 | Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1. |
| FG001 | MSC2156119J Regimen 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline up to 158.01 weeks |
| Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 1 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 2 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 3 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 1 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 2 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
| Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 3 | Reporting group "MSC2156119J 1200 mg: Fasted" is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group "MSC2156119J 1400 mg: Fed". | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 1 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 2 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48, 49.32 hours post-dose on Day 1 Cycle 1 |
| Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 3 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 1 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 2 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
| Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 3 | Reporting group "MSC2156119J 1200 mg: Fasted" is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group "MSC2156119J 1400 mg: Fed". | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 1 | Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 2 | Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 3 | Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 1 | Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 2 | Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
| Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 3 | Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Area Under Plasma Concentration Versus Time Curve From Time Zero to Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 1 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 2 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 3 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 1 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 2 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 3 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Reporting group "MSC2156119J 1200 mg: Fasted" is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group "MSC2156119J 1400 mg: Fed". | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 1 | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 2 | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 3 | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 1 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 2 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 1 Cycle 1 |
| Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 3 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 1 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 2 | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 19 Cycle 1 |
| Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 3 | Reporting group "MSC2156119J 1200 mg: Fasted" is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group "MSC2156119J 1400 mg: Fed". | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 1 | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 2 | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 3 | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 1 | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 2 | 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 serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 3 | 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 serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 1 | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 2 | 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 serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
| Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 3 | 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 serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 1 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 2 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 3 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 1 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 2 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
| Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 3 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| Absolute Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2 | Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein. | Baseline, Day 1 Cycle 2 |
| Fold Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2 | Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein. Fold change = on-treatment value/ baseline value | Baseline, Day 1 Cycle 2 |
| Number of Subjects With Monovalent Antagonist Antibody to Receptor MET (MetMAb) Score (MMS) | MetMAb score was used to assess the tumor c-Met expression and ranged from 0 to 3, where a score of 0 corresponds to the lowest c-Met expression and a score of 3 corresponds to the highest c-Met expression in tumor tissue by immunohistochemistry. | Day 1 Cycle 2 |
| Relative Percentage Change In Sum of Longest Diameter (SOLD) of Target Lesions to Post-Baseline Nadir | The post-baseline nadir was defined as the the smallest SOLD recorded after baseline. The relative change (%) was derived based on the SOLD of target lesions as follows: 100* (SOLD at post-baseline nadir - baseline SOLD) / baseline SOLD. | Baseline, On Treatment (up to 153.3 weeks) |
| Number of Subjects With Best Overall Response (BOR) | Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study. | Baseline up to 153.3 weeks |
| Progression-free Survival (PFS) | PFS was defined as the time (in months) between the first dosing day and radiographic PD or clinical PD (as recorded on the study termination form) or death, if death occurred within 12 weeks (84 days) after the last tumor assessment without documented progressive disease, whichever occurred first. Any subject with neither assessment of tumor progression, nor death within 12 weeks after last tumor assessment date was censored on the date of last tumor assessment. | Baseline up to 153.3 weeks |
| Derived |
| Xiong W, Hietala SF, Nyberg J, Papasouliotis O, Johne A, Berghoff K, Goteti K, Dong J, Girard P, Venkatakrishnan K, Strotmann R. Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations. Cancer Chemother Pharmacol. 2022 Jul;90(1):53-69. doi: 10.1007/s00280-022-04441-3. Epub 2022 Jun 30. |
| US Medical Information website, Medical Resources | View source |
| Redacted Clinical study report, redacted clinical study protocol and redacted statistical analysis plan for this study is also available at the HC-PRCI portal (Health Canada-Public release of clinical information) | View source |
Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2. |
| FG002 | MSC2156119J Regimen 3 | Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3. |
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Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | MSC2156119J Regimen 1 | Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1. |
| BG001 | MSC2156119J Regimen 2 | Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2. |
| BG002 | MSC2156119J Regimen 3 | Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||
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| Primary | Number of Subjects With Any Dose Limiting Toxicity (DLT) | DLT was defined as one of the following adverse events (AEs) observed during Cycle1, regardless of MSC2156119J relationship, excluding AEs assessed by investigator exclusively related to subject's underlying disease or medical condition: Grade 4 neutropenia for >7 days; Grade >=3 febrile neutropenia for >1 day; Grade 4 thrombocytopenia/Grade 3 with bleeding; Grade >=3 nausea and emesis, despite optimal treatment; Grade >=3 non-hematological AE, except emesis and nausea with no adequate therapy and alopecia, Grade >= 3 liver AE with a recovery period of >7 days or to Grade <=1 for subjects without liver metastases or to <=2 for subjects with liver metastases; Grade >=3 lipase and/or amylase rise with pancreatitis confirmation, either based on clinical or radiological signs. Any AE not otherwise defined as a DLT that, due to prolonged recovery to Grade <=1 or baseline status, leads to delay of above 21 days in planned administration of study drug. | DLT analysis set comprised of subjects who had either completed Cycle 1 or had stopped treatment because of a DLT during Cycle 1. | Posted | Number | subjects | Day 1, 3, 8, 14, 17 of Cycle 1 (for Regimen 1 and 3); Day 1, 3, 8, 15, 19 of Cycle 1 (for Regimen 2) |
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| Primary | Recommended Phase 2 Dose (RP2D) | MTD was defined as the dose level at which 2 out of 3 subjects or 2 out of 6 subjects experienced a DLT. The primary endpoint was to determine MTD of MSC2156119J for each of the 3 treatment regimens in subjects with advanced solid tumors. However, during the course of the trial it was established that the MTD could not be determined and instead, RP2D was to be determined. | DLT analysis set comprised of subjects who had either completed Cycle 1 or had stopped treatment because of a DLT during Cycle 1. | Posted | Number | milligram | Cycle 1 (Day 1 to Day 21) |
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| Primary | Number of Subjects With Treatment-Related Adverse Events | Related AE was defined as any untoward medical occurrence which was considered to have a relationship with the study drug (suspected to be reasonably related to the study drug or AE was medically (pharmacologically/clinically) attributed to the study drug as per Investigator's assessment. | Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. | Posted | Number | subjects | Baseline up to 158.01 weeks |
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| Secondary | Number of Subjects With Treatment-Emergent AEs (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death | AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs. | Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. | Posted | Number | subjects | Baseline up to 158.01 weeks |
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| Secondary | Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 1 | Pharmacokinetic (PK) analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 2 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 3 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 1 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 2 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
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| Secondary | Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 3 | Reporting group "MSC2156119J 1200 mg: Fasted" is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group "MSC2156119J 1400 mg: Fed". | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 1 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Median | Full Range | hours | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 2 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Median | Full Range | hours | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48, 49.32 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 3 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Median | Full Range | hours | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 1 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Median | Full Range | hours | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 2 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure | Posted | Median | Full Range | hours | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
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| Secondary | Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 3 | Reporting group "MSC2156119J 1200 mg: Fasted" is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group "MSC2156119J 1400 mg: Fed". | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Median | Full Range | hours | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 1 | Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 2 | Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 3 | Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 1 | Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 2 | Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
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| Secondary | Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 3 | Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Area Under Plasma Concentration Versus Time Curve From Time Zero to Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 1 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 2 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 3 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 1 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 2 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 3 | Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Reporting group "MSC2156119J 1200 mg: Fasted" is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group "MSC2156119J 1400 mg: Fed". | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 1 | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 2 | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 3 | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 1 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 2 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 3 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 1 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 2 | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 19 Cycle 1 |
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| Secondary | Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 3 | Reporting group "MSC2156119J 1200 mg: Fasted" is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group "MSC2156119J 1400 mg: Fed". | PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
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| Secondary | Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 1 | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 2 | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
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| Secondary | Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 3 | Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0-inf. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 1 | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 2 | 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 serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 3 | 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 serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 1 | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 2 | 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 serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 3 | 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 serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 1 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 2 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 3 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 1 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 2 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 3 | Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant. | Posted | pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2 | Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein. | Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 1 Cycle 2 |
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| Secondary | Fold Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2 | Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein. Fold change = on-treatment value/ baseline value | Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here "Number of Participants analyzed" signifies those subjects who were evaluable for this outcome and "n" signifies those subjects who were evaluable in the specified category for each arm, respectively. | Posted | Mean | Standard Deviation | fold change | Baseline, Day 1 Cycle 2 |
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| Secondary | Number of Subjects With Monovalent Antagonist Antibody to Receptor MET (MetMAb) Score (MMS) | MetMAb score was used to assess the tumor c-Met expression and ranged from 0 to 3, where a score of 0 corresponds to the lowest c-Met expression and a score of 3 corresponds to the highest c-Met expression in tumor tissue by immunohistochemistry. | Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. | Posted | Number | subjects | Day 1 Cycle 2 |
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| Secondary | Relative Percentage Change In Sum of Longest Diameter (SOLD) of Target Lesions to Post-Baseline Nadir | The post-baseline nadir was defined as the the smallest SOLD recorded after baseline. The relative change (%) was derived based on the SOLD of target lesions as follows: 100* (SOLD at post-baseline nadir - baseline SOLD) / baseline SOLD. | Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here "Number of Participants Analyzed" signifies those subjects who presented a measurable tumor at baseline and at least one post-baseline tumor assessment. | Posted | Mean | Standard Deviation | percent change | Baseline, On Treatment (up to 153.3 weeks) |
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| Secondary | Number of Subjects With Best Overall Response (BOR) | Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study. | Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. | Posted | Number | subjects | Baseline up to 153.3 weeks |
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| Secondary | Progression-free Survival (PFS) | PFS was defined as the time (in months) between the first dosing day and radiographic PD or clinical PD (as recorded on the study termination form) or death, if death occurred within 12 weeks (84 days) after the last tumor assessment without documented progressive disease, whichever occurred first. Any subject with neither assessment of tumor progression, nor death within 12 weeks after last tumor assessment date was censored on the date of last tumor assessment. | Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here, "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | Median | 90% Confidence Interval | months | Baseline up to 153.3 weeks |
|
Baseline up to 158.01 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MSC2156119J Regimen 1 | Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1. | 14 | 42 | 41 | 42 | ||
| EG001 | MSC2156119J Regimen 2 | Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2. | 17 | 45 | 45 | 45 | ||
| EG002 | MSC2156119J Regimen 3 | Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3. | 22 | 62 | 59 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION | Endocrine disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| FAECALOMA | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MESENTERIC VEIN THROMBOSIS | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DEVICE OCCLUSION | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PAIN | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| JAUNDICE CHOLESTATIC | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| STAPHYLOCOCCAL BACTERAEMIA | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| ABDOMINAL WALL INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| GANGRENE | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| KIDNEY INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| LOBAR PNEUMONIA | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| TRACHEOBRONCHITIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| WAIST CIRCUMFERENCE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VAGUS NERVE DISORDER | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| JUGULAR VEIN THROMBOSIS | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SUPERIOR VENA CAVA SYNDROME | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ANAEMIA OF CHRONIC DISEASE | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| THROMBOCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SINUS ARRHYTHMIA | Cardiac disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DEAFNESS | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| EAR DISCOMFORT | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| EAR SWELLING | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MIDDLE EAR EFFUSION | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VERTIGO POSITIONAL | Ear and labyrinth disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BASEDOW'S DISEASE | Endocrine disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| THYROID DISORDER | Endocrine disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DRY EYE | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLEPHAROSPASM | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RETINAL PIGMENT EPITHELIOPATHY | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VITREOUS FLOATERS | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ABDOMINAL MASS | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| CHANGE OF BOWEL HABIT | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ERUCTATION | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| FAECAL INCONTINENCE | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| FAECES DISCOLOURED | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GASTROINTESTINAL MOTILITY DISORDER | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GASTROINTESTINAL SOUNDS ABNORMAL | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GINGIVAL PAIN | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| LIP SWELLING | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NEUROGENIC BOWEL | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ODYNOPHAGIA | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RETCHING | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| AXILLARY PAIN | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| EARLY SATIETY | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| LOCAL SWELLING | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PAIN | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| CATHETER SITE ERYTHEMA | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| FEELING COLD | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| LOCALISED OEDEMA | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SENSATION OF FOREIGN BODY | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| JAUNDICE | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PORTAL VEIN THROMBOSIS | Hepatobiliary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ALLERGY TO ARTHROPOD BITE | Immune system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| FUNGAL INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| HORDEOLUM | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| INFECTED FISTULA | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| NAIL BED INFECTION FUNGAL | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| ONYCHOMYCOSIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| PAROTITIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| TOOTH ABSCESS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION BACTERIAL | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| EPICONDYLITIS | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| FEEDING TUBE COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| NAIL INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| RADIATION PNEUMONITIS | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| STOMA SITE HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BREATH SOUNDS ABNORMAL | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| AMYLASE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| HAEMOGLOBIN INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| INTERNATIONAL NORMALISED RATIO INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| PROSTATIC SPECIFIC ANTIGEN INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD CREATINE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD GLUCOSE DECREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD PRESSURE DIASTOLIC ABNORMAL | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLOOD UREA INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| ELECTROCARDIOGRAM PR SHORTENED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| ELECTROCARDIOGRAM ST SEGMENT ELEVATION | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| HAEMATOCRIT INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| PEDAL PULSE ABNORMAL | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| WAIST CIRCUMFERENCE INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOKALAEMIA | Investigations | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MALNUTRITION | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| JOINT ANKYLOSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MYOPATHY | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SEBORRHOEIC KERATOSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| OESOPHAGEAL CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| TUMOUR INVASION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| AKATHISIA | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BALANCE DISORDER | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DIZZINESS POSTURAL | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSKINESIA | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOGEUSIA | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VIITH NERVE PARALYSIS | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VOCAL CORD PARALYSIS | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DISORIENTATION | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| EMOTIONAL DISTRESS | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| FLAT AFFECT | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RESTLESSNESS | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| CHROMATURIA | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| GLYCOSURIA | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NEUROGENIC BLADDER | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RENAL ATROPHY | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RENAL HYPERTROPHY | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| URETERIC OBSTRUCTION | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| URINARY HESITATION | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SCROTAL OEDEMA | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NIPPLE PAIN | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VAGINAL DISCHARGE | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BREAST MASS | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BREAST SWELLING | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BREAST TENDERNESS | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSPAREUNIA | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NIPPLE DISORDER | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PENILE OEDEMA | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SCROTAL SWELLING | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| TESTICULAR SWELLING | Reproductive system and breast disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| TACHYPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RASH VESICULAR | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SWELLING FACE | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ACTINIC KERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| BLISTER | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERKERATOSIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| INGROWING NAIL | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ONYCHOCLASIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| ONYCHOLYSIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RASH GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| RASH PRURITIC | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SKIN MASS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| STASIS DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| SUBCLAVIAN VEIN THROMBOSIS | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| THROMBOPHLEBITIS SUPERFICIAL | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| THROMBOSIS | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| VENOUS THROMBOSIS | Vascular disorders | MedDRA 18.0 | Non-systematic Assessment |
|
It was not possible to calculate data for PK parameters such as t1/2, AUC0-inf, CL/f, Vz/f, λz because dosing interval was too small compared to the long half-life to characterize terminal phase rate constant, which is needed for the calculation.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| C582858 | EMD1214063 |
| C000707607 | tepotinib |
Not provided
Not provided
Not provided
| Male |
|
|
|
|
| OG002 | MSC2156119J Regimen 3 | Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3. |
|
|
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
|
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
|
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1200 mg: Fasted | Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
|
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
|
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
|
| OG003 | MSC2156119J 700 mg: Fed | Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
|
| OG004 |
| MSC2156119J 215 mg: Fed |
Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
|
| OG004 |
| MSC2156119J 315 mg: Fed |
Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
|
| OG004 |
| MSC2156119J 1000 mg: Fed |
Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1200 mg: Fasted | Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 500 mg Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
|
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
|
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
|
| OG003 | MSC2156119J 700 mg: Fed | Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
|
Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
| OG004 | MSC2156119J 1000 mg Fed | Subjects were administered with micronized MSC2156119J 1000 mg with food. |
| OG005 | MSC2156119J 1200 mg Fasted | Subjects were administered with micronized MSC2156119J 1200 mg in the fasted state. |
| OG006 | MSC2156119J 1400 mg Fed | Subjects were administered with micronized MSC2156119J 1400 mg with food. |
| OG007 | MSC2156119J 500 mg Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet) with food. |
|
Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
| OG003 |
| MSC2156119J 145 mg: Fed |
Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
|
| OG003 |
| MSC2156119J 175 mg: Fed |
Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
|
| OG003 |
| MSC2156119J 700 mg: Fed |
Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1200 mg: Fasted | Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
|
| OG003 | MSC2156119J 145 mg: Fed | Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
|
| OG003 | MSC2156119J 175 mg: Fed | Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
|
| MSC2156119J 500 mg: Fed |
Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food. |
| OG003 | MSC2156119J 700 mg: Fed | Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
|
| OG003 | MSC2156119J 145 mg Fed | Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 215 mg Fed | Subjects were administered with micronized MSC2156119J 215 mg with food. |
| OG005 | MSC2156119J 300 mg Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
| OG003 | MSC2156119J 175 mg: Fed | Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
| OG003 | MSC2156119J 700 mg Fed | Subjects were administered with micronized MSC2156119J 700 mg with food. |
| OG004 | MSC2156119J 1000 mg Fed | Subjects were administered with micronized MSC2156119J 1000 mg with food. |
| OG005 | MSC2156119J 1200 mg Fasted | Subjects were administered with micronized MSC2156119J 1200 mg in the fasted state. |
| OG006 | MSC2156119J 1400 mg Fed | Subjects were administered with micronized MSC2156119J 1400 mg with food. |
| OG007 | MSC2156119J 500 mg Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (Tablet) with food. |
|
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
|
Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
|
Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1200 mg: Fasted | Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
|
Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
|
Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
|
Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
| OG003 | MSC2156119J 700 mg: Fed | Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
|
Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1200 mg: Fasted | Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
| MSC2156119J 145 mg: Fed |
Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
| MSC2156119J 175 mg: Fed |
Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
| MSC2156119J 700 mg: Fed |
Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1200 mg: Fasted | Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 500 mg Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
| MSC2156119J 145 mg: Fed |
Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
| MSC2156119J 175 mg: Fed |
Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
| MSC2156119J 700 mg: Fed |
Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food. |
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1200 mg: Fasted | Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
| OG004 | MSC2156119J 215 mg: Fed | Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 300 mg: Fed | Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 400 mg: Fed | Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food. |
| OG007 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG009 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG010 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
| OG011 | MSC2156119J 230 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state. |
|
| OG004 | MSC2156119J 315 mg: Fed | Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 30 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state. |
| OG006 | MSC2156119J 60 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state. |
| OG007 | MSC2156119J 115 mg: Fasted | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state. |
| OG008 | MSC2156119J 115 mg: Fed | Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food. |
|
| OG004 | MSC2156119J 1000 mg: Fed | Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food. |
| OG005 | MSC2156119J 1400 mg: Fed | Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food. |
| OG006 | MSC2156119J 500 mg: Fed (Tablet) | Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food. |
|
| OG002 | MSC2156119J Regimen 3 | Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3. |
|
|
Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
| OG002 | MSC2156119J Regimen 3 | Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3. |
|
|
|
|
Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
|
|
Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
| OG002 | MSC2156119J Regimen 3 | Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3. |
|
|
Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3. |
|
|