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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003381-13 | EudraCT Number |
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The purpose of this study was to investigate the effect of multiple doses of carbamazepine on two single doses of evobrutinib pharmacokinetics (PK) in healthy participants. Study details included:
Study Duration: up to 54 days. Treatment Duration: 25 days. Visit Frequency: Participants were residents in the Clinical Research Unit from Day 1 to Day 20 and returned on Day 26 for a Safety Follow-Up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evobrutinib plus Carbamazepine | Experimental | Participants received a single oral dose of Evobrutinib 45 mg on Day 1 and Day 19 under fed condition followed by Cabamazepine 100 mg on Days 2 and 3, 200 mg on Days 4 and 5 and then 300 mg from Days 6 to 19 and were titrated back to 200 mg from Days 20 to 22 and 100 mg on Days 23 to 25 twice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evobrutinib | Drug | Participants received a single oral dose of Evobrutinib 45 mg on Day 1 and Day 19 |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC0-inf) of Evobrutinib | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
| Maximum Observed Plasma Concentration (Cmax) of Evobrutinib | Cmax was obtained from plasma concentration time curve. | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 16 and 24 hours post dose on Day 1 and Day 19. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Serious TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study intervention. A serious adverse event (SAE) was any untoward medical occurrence 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. TEAE's were those events with onset dates on or after the first administration of study intervention. TEAEs include both Serious TEAEs and non-serious TEAEs." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Neu-Ulm | Bavaria | Germany |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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A total of 18 participants were planned out of which 14 participants received study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Evobrutinib + Carbamazepine | Participants received a single oral dose of Evobrutinib 45 mg on Day 1 and Day 19 under fed condition followed by Cabamazepine 100 mg on Days 2 and 3, 200 mg on Days 4 and 5 and then 300 mg from Days 6 to 19 and were titrated back to 200 mg from Days 20 to 22 and 100 mg on Days 23 to 25 twice daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Evobrutinib + Carbamazepine | Participants received a single oral dose of Evobrutinib 45 mg on Day 1 and Day 19 under fed condition followed by Cabamazepine 100 mg on Days 2 and 3, 200 mg on Days 4 and 5 and then 300 mg from Days 6 to 19 and were titrated back to 200 mg from Days 20 to 22 and 100 mg on Days 23 to 25 twice daily. |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (AUC0-inf) of Evobrutinib | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour*nanograms per milliliter (h*ng/mL) | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
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Baseline (Day 1) up to Day 26
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evobrutinib + Carbamazepine | Participants received a single oral dose of Evobrutinib 45 mg on Day 1 and Day 19 under fed condition followed by Cabamazepine 100 mg on Days 2 and 3, 200 mg on Days 4 and 5 and then 300 mg from Days 6 to 19 and were titrated back to 200 mg from Days 20 to 22 and 100 mg on Days 23 to 25 twice daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diplopia | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2021 | Oct 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2022 | Oct 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000632111 | evobrutinib |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Carbamazepine | Drug | Participants received Carbamazepine 100 mg on Days 2 and 3, 200 mg on Days 4 and 5 and then 300 mg from Days 6 to 19 and were titrated back to 200 mg from Days 20 to 22 and 100 mg on Days 23 to 25 twice daily. |
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| Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Hematology Parameter: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, and Lymphocytes Values | Blood samples were collected to analyze the hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, and Lymphocytes Values. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline was calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Hematology Parameter: Hemoglobin Levels | Blood samples were collected to analyze the hematology parameter: Hemoglobin levels. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Hematology Parameter: Hematocrit Values | Blood samples were collected to analyze the hematology parameter: Hematocrit Value. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Hematology Parameter: Activated Partial Thromboplastin Time | Blood samples were collected to analyze the hematology parameter: Activated Partial Thromboplastin Time. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/ Leukocytes, and Neutrophils/Leukocytes | Blood samples were collected to analyze the hematology parameter: basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/ leukocytes, and neutrophils/leukocytes. The data in terms of 'percentage of cells' was calculated as: Count of Basophils (10^9 cells/L) (or any other defined hematology parameter e.g. Neutrophils, Eosinophils etc.) divided by the total count of Leukocytes (10^9 cells/L) in the blood multiplied by 100." | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Blood samples were collected to analyze the hematology parameter: Prothrombin International Normalized Ratio. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. Percent=Fraction×100 | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Biochemistry Parameter: Bilirubin, Creatinine and Urate | Blood samples were collected to analyze the Biochemistry Parameter: Bilirubin, Creatinine and Urate. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Biochemistry Parameter: Sodium, Potassium, Calcium, Magnesium and Phosphate Levels | Blood samples were collected to analyze the Biochemistry Parameter: Sodium, Potassium, Calcium, Magnesium and Phosphate Levels. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Biochemistry Parameter: Protein and Albumin Levels | Blood samples were collected to analyze the Biochemistry Parameter: Protein and Albumin Levels. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Biochemistry Parameter: Alkaline Phosphatase, Amylase, Lipase, Creatinine Kinase, Gamma Glutamyl Transferase Levels, Lactate Dehydrogenase, Aspartate Aminotransferase | Biochemistry Parameter: Alkaline Phosphatase, Amylase, Lipase, Creatinine Kinase, Gamma Glutamyl Transferase Levels, Lactate Dehydrogenase, Aspartate Aminotransferase. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Biochemistry Parameter: Glucose, Chloride, Cholesterol, Triglycerides, Phosphate Levels | Biochemistry Parameter: Glucose, Chloride, Cholesterol, Triglycerides, Phosphate levels. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in 12-Lead ECG Parameter: Heart Rate | 12-Lead ECGs were collected after the participants rested quietly for at least 10 minutes in a supine position. 12-Lead ECG Parameter: Heart Rate. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in 12-Lead ECG Parameter: RR Duration, QT Duration, Fridericia's Formula (QTcF), PR Duration and QRS Duration | 12-Lead ECGs were collected after the participants rested quietly for at least 10 minutes in a supine position. 12-Lead ECG Parameter: RR Duration. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Vital Sign: Blood Pressure | Blood pressure (systolic and diastolic) was measured after at least 5 minutes resting, with the participant in the seated position without distractions. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Vital Sign: Pulse Rate | Pulse rate was measured after at least 5 minutes resting, with the subject in the seated position without distractions. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Vital Sign: Respiratory Rate | Respiratory Rate was measured after at least 5 minutes resting, with the participant in the seated position without distractions. | Baseline (Day 1) and Day 26 |
| Absolute Change From Baseline in Vital Sign: Body Temperature | The absolute changes from baseline in Body Temperature (degree Celsius [°C]) were reported. | Baseline Day 1 and Day 26 |
| Total Body Clearance of Evobrutinib From Plasma (CL/f) | CL/f was defined as the apparent total clearance of the drug from plasma after extravascular administration. | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
| Apparent Volume of Distribution (Vz/f) of Evobrutinib | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. The apparent volume of distribution during the terminal phase following extravascular administration and was calculated by using the formula=Dose/ (AUC0-inf* λz). | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Evobrutinib | The AUC from time zero (= dosing time) to the time of the last quantifiable concentration (tlast). | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
| Time to Reach the Maximum Plasma Concentration (Tmax) of Evobrutinib | Tmax was obtained directly from the concentration versus time curve. | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
| Apparent Terminal Half-Life (t1/2) of Evobrutinib in Plasma | t1/2 was defined as the time taken for the plasma concentration or the amount of drug in the body to be reduced by half. Terminal half-life calculated by natural log 2 divided by lambda z. | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Evobrutinib Metabolite (MSC2729909A) | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (LOQ) (AUC0-tlast) of Evobrutinib Metabolite (MSC2729909A) | The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration was at or above LOQ. Calculated using the mixed log-linear trapezoidal rule (linear up, log down). | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
| Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Metabolite (MSC2729909A) | Cmax was obtained from plasma concentration time curve. | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
| Time to Reach the Maximum Plasma Concentration (Tmax) of Evobrutinib Metabolite (MSC2729909A) | Tmax was obtained directly from the concentration versus time curve. | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
| Time Prior to the First Quantifiable (Non-zero) Concentration (Tlag) of Evobrutinib Metabolite (MSC2729909A) in Plasma | The time prior to the first concentration at or above limit of quantification. It is calculated as last time point at which the concentration is less than (<) Lower Limit of Quantification (LLOQ) before the occurrence of the first quantifiable concentration. | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
| Metabolite to Parent Ratios for Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Evobrutinib Metabolite (MSC2729909A) | Molecular weight-corrected ratio of metabolite (M) AUC0-inf to parent (P) AUC0-inf: M/P(AUC0-inf) = (AUC0-inf metabolite (MSC2729909A) *molecular weight (MW) parent) / (AUC0-inf parent*MW metabolite (MSC2729909A)). | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
| Metabolite to Parent Ratios for Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Metabolite (MSC2729909A) | Molecular weight-corrected ratio of metabolite Cmax to parent Cmax: M/P(Cmax) = (Cmaxmetabolite (MSC2729909A) * MWparent) / (Cmax parent * MW metabolite (MSC2729909A)). | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity | AE was defined as any untoward medical occurrence in a subject. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study intervention. SAE was any untoward medical occurrence 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. TEAE's were those events with onset dates on or after the first administration of study intervention. TEAEs include both Serious TEAEs and non-serious TEAEs. Severity of AE were assessed by the investigator as Mild, Moderate, and Severe: An event that prevents normal everyday activities. Severe is a category used to rate the intensity of an event; both AEs and SAEs can be assessed as severe. SAS is used. | Baseline (Day 1) and Day 26 |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG000 | Evobrutinib | Participants received a single oral dose of Evobrutinib 45mg on Day 1. |
| OG001 | Evobrutinib + Carbamazepine | Participants received a single oral dose of Evobrutinib 45 milligram (mg) on Day 1 and Day 19 under fed condition followed by Cabamazepine 100 mg on Days 2 and 3, 200 mg on Days 4 and 5 and then 300 mg from Days 6 to 19 and were titrated back to 200 mg from Days 20 to 22 and 100 mg on Days 23 to 25 twice daily. |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Evobrutinib | Cmax was obtained from plasma concentration time curve. | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Serious TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study intervention. A serious adverse event (SAE) was any untoward medical occurrence 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. TEAE's were those events with onset dates on or after the first administration of study intervention. TEAEs include both Serious TEAEs and non-serious TEAEs." | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Hematology Parameter: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, and Lymphocytes Values | Blood samples were collected to analyze the hematology parameters: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, and Lymphocytes Values. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline was calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | 10^9 cells/Liter | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Hematology Parameter: Hemoglobin Levels | Blood samples were collected to analyze the hematology parameter: Hemoglobin levels. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Hematology Parameter: Hematocrit Values | Blood samples were collected to analyze the hematology parameter: Hematocrit Value. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | litre of cells per litre of blood (L/L) | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Hematology Parameter: Activated Partial Thromboplastin Time | Blood samples were collected to analyze the hematology parameter: Activated Partial Thromboplastin Time. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | seconds | Baseline (Day 1) and Day 26 |
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| Secondary | Change From Baseline in Hematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/ Leukocytes, and Neutrophils/Leukocytes | Blood samples were collected to analyze the hematology parameter: basophils/leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes, monocytes/ leukocytes, and neutrophils/leukocytes. The data in terms of 'percentage of cells' was calculated as: Count of Basophils (10^9 cells/L) (or any other defined hematology parameter e.g. Neutrophils, Eosinophils etc.) divided by the total count of Leukocytes (10^9 cells/L) in the blood multiplied by 100." | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | Percentage of cells | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | Picograms | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | Femtoliter | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Blood samples were collected to analyze the hematology parameter: Prothrombin International Normalized Ratio. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. Percent=Fraction×100 | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | percent | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Biochemistry Parameter: Bilirubin, Creatinine and Urate | Blood samples were collected to analyze the Biochemistry Parameter: Bilirubin, Creatinine and Urate. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | micromole/liter (umol/L) | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Biochemistry Parameter: Sodium, Potassium, Calcium, Magnesium and Phosphate Levels | Blood samples were collected to analyze the Biochemistry Parameter: Sodium, Potassium, Calcium, Magnesium and Phosphate Levels. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | Millimoles per litre (mmol/L) | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Biochemistry Parameter: Protein and Albumin Levels | Blood samples were collected to analyze the Biochemistry Parameter: Protein and Albumin Levels. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | g/L | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Biochemistry Parameter: Alkaline Phosphatase, Amylase, Lipase, Creatinine Kinase, Gamma Glutamyl Transferase Levels, Lactate Dehydrogenase, Aspartate Aminotransferase | Biochemistry Parameter: Alkaline Phosphatase, Amylase, Lipase, Creatinine Kinase, Gamma Glutamyl Transferase Levels, Lactate Dehydrogenase, Aspartate Aminotransferase. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | Units per litre (U/L) | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Biochemistry Parameter: Glucose, Chloride, Cholesterol, Triglycerides, Phosphate Levels | Biochemistry Parameter: Glucose, Chloride, Cholesterol, Triglycerides, Phosphate levels. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all subjects, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | mmol/L | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in 12-Lead ECG Parameter: Heart Rate | 12-Lead ECGs were collected after the participants rested quietly for at least 10 minutes in a supine position. 12-Lead ECG Parameter: Heart Rate. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | beats per minute | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in 12-Lead ECG Parameter: RR Duration, QT Duration, Fridericia's Formula (QTcF), PR Duration and QRS Duration | 12-Lead ECGs were collected after the participants rested quietly for at least 10 minutes in a supine position. 12-Lead ECG Parameter: RR Duration. Baseline was the last scheduled measurement before administration of study intervention. Absolute changes from baseline were calculated by subtracting the post-dose visit value from the Baseline value. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | Millisecond (msec) | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Vital Sign: Blood Pressure | Blood pressure (systolic and diastolic) was measured after at least 5 minutes resting, with the participant in the seated position without distractions. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Vital Sign: Pulse Rate | Pulse rate was measured after at least 5 minutes resting, with the subject in the seated position without distractions. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | beats per min | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Vital Sign: Respiratory Rate | Respiratory Rate was measured after at least 5 minutes resting, with the participant in the seated position without distractions. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | breaths per minute | Baseline (Day 1) and Day 26 |
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| Secondary | Absolute Change From Baseline in Vital Sign: Body Temperature | The absolute changes from baseline in Body Temperature (degree Celsius [°C]) were reported. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Mean | Standard Deviation | Degree Celsius | Baseline Day 1 and Day 26 |
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| Secondary | Total Body Clearance of Evobrutinib From Plasma (CL/f) | CL/f was defined as the apparent total clearance of the drug from plasma after extravascular administration. | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Litres per hour (L/h) | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Apparent Volume of Distribution (Vz/f) of Evobrutinib | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. The apparent volume of distribution during the terminal phase following extravascular administration and was calculated by using the formula=Dose/ (AUC0-inf* λz). | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Evobrutinib | The AUC from time zero (= dosing time) to the time of the last quantifiable concentration (tlast). | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) of Evobrutinib | Tmax was obtained directly from the concentration versus time curve. | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. | Posted | Median | Full Range | hours | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Apparent Terminal Half-Life (t1/2) of Evobrutinib in Plasma | t1/2 was defined as the time taken for the plasma concentration or the amount of drug in the body to be reduced by half. Terminal half-life calculated by natural log 2 divided by lambda z. | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = number of participants evaluable for this outcome measure. | Posted | Median | Full Range | hours | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Evobrutinib Metabolite (MSC2729909A) | AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase. | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*ng/mL | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (LOQ) (AUC0-tlast) of Evobrutinib Metabolite (MSC2729909A) | The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration was at or above LOQ. Calculated using the mixed log-linear trapezoidal rule (linear up, log down). | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Metabolite (MSC2729909A) | Cmax was obtained from plasma concentration time curve. | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliters (ng/mL) | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) of Evobrutinib Metabolite (MSC2729909A) | Tmax was obtained directly from the concentration versus time curve. | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. | Posted | Median | Full Range | hours | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Time Prior to the First Quantifiable (Non-zero) Concentration (Tlag) of Evobrutinib Metabolite (MSC2729909A) in Plasma | The time prior to the first concentration at or above limit of quantification. It is calculated as last time point at which the concentration is less than (<) Lower Limit of Quantification (LLOQ) before the occurrence of the first quantifiable concentration. | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = number of participants evaluable for this outcome measure. | Posted | Median | Full Range | hours | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Metabolite to Parent Ratios for Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Evobrutinib Metabolite (MSC2729909A) | Molecular weight-corrected ratio of metabolite (M) AUC0-inf to parent (P) AUC0-inf: M/P(AUC0-inf) = (AUC0-inf metabolite (MSC2729909A) *molecular weight (MW) parent) / (AUC0-inf parent*MW metabolite (MSC2729909A)). | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Metabolite to Parent Ratios for Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Metabolite (MSC2729909A) | Molecular weight-corrected ratio of metabolite Cmax to parent Cmax: M/P(Cmax) = (Cmaxmetabolite (MSC2729909A) * MWparent) / (Cmax parent * MW metabolite (MSC2729909A)). | The Pharmacokinetic Analysis Set included all participants who had completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Evobrutinib: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12,16 and 24 hours post dose on Day 1 and Day 19. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity | AE was defined as any untoward medical occurrence in a subject. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study intervention. SAE was any untoward medical occurrence 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. TEAE's were those events with onset dates on or after the first administration of study intervention. TEAEs include both Serious TEAEs and non-serious TEAEs. Severity of AE were assessed by the investigator as Mild, Moderate, and Severe: An event that prevents normal everyday activities. Severe is a category used to rate the intensity of an event; both AEs and SAEs can be assessed as severe. SAS is used. | The safety analysis set included all participants, who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Baseline (Day 1) and Day 26 |
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| 0 |
| 14 |
| 0 |
| 14 |
| 14 |
| 14 |
| Eyelid ptosis | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Photophobia | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Faeces hard | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Feeling drunk | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Rash pustular | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Listless | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Terminal insomnia | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
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Not provided
Not provided
| Title | Measurements |
|---|---|
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| Eosinophils |
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| Basophils |
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| Monocytes |
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| Lymphocytes |
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| Title | Measurements |
|---|---|
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| Monocytes/Leukocytes |
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| Neutrophils/Leukocytes |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Magnesium Levels |
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| Phosphate Levels |
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| Title | Measurements |
|---|---|
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| Creatine Kinase |
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| Gamma Glutamyl Transferase |
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| Lactate Dehydrogenase |
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| Aspartate Aminotransferase |
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| Title | Measurements |
|---|---|
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| Triglycerides |
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| Phosphate |
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| Title | Measurements |
|---|---|
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| PR Duration |
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| QRS Duration |
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| Title | Measurements |
|---|
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