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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003546-20 | EudraCT Number |
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The purpose of this study was to assess the effect of multiple doses of carbamazepine on single- dose tepotinib pharmacokinetics in healthy participants. Study details include: Study Duration: up to about 10 weeks; Treatment Duration: single dose of tepotinib on Days 1 and 26, 25 days of treatment with carbamazepine (Days 8 to 32); Visit Frequency: residence in the Clinical Research Unit from Days -1 to 4 and Days 25 to 29, ambulatory daily visits from Days 5 to 24 and 30 to 33, and one ambulatory visit on Day 39.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tepotinib then Carbamazepine | Experimental | Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1 and Day 26 in the morning under fed state followed by Carbamazepine 100, 200 or 300mg oral dose under fed state twice daily at the same time each day in the morning and evening from Days 8 to Day 32 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tepotinib | Drug | Participants received Tepotinib hydrochloride hydrate film-coated tablet once daily with food on Day 1 and Day 26 in the morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tepotinib | The AUC from time zero (= dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from lambda (λ)z determination. | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of Tepotinib | The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down). | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) of Tepotinib | Cmax was obtained directly from the concentration versus time curve. | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAES With Severity of Grade Greater or Equal to 3 | 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. Severity of abnormalities were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version [24.1]. grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE |
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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 | 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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Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients 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 https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
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A total of 29 participants were screened, out of which 18 participants received the study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tepotinib Then Carbamazepine | Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1 and Day 26 in the morning under fed state followed by Carbamazepine 100 mg twice daily at Day 8 and 9, 200 mg twice daily at Day 10 and 11, 300 mg twice daily from Day 12 to 32. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tepotinib Then Carbamazepine | Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1 and Day 26 in the morning under fed state followed by Carbamazepine 100 mg twice daily at Day 8 and 9, 200 mg twice daily at Day 10 and 11, 300 mg twice daily from Day 12 to 32. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 From Time Zero Extrapolated to Infinity (AUC0-inf) of Tepotinib | The AUC from time zero (= dosing time) extrapolated to infinity, based on the predicted value for the concentration at tlast, as estimated using the linear regression from lambda (λ)z determination. | PK analysis set included all participants who had administered any dose of any study intervention and completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = overall number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours* nanograms per milliliter(h*ng/mL) | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
|
Baseline (Day 1) up to 10 Weeks
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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 | Tepotinib | Participants received 500 mg of Tepotinib hydrochloride hydrate film coated tablet once daily with food on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
[Not Specified]
| 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 | Feb 21, 2022 | May 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2022 | May 4, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000707607 | tepotinib |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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This is a single sequence cross-over trial.
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| Carbamazepine | Drug | Carbamazepine 100 mg twice daily at Day 8 and 9, 200 mg twice daily at Day 10 and 11, 300 mg twice daily from Day 12 to 32. |
|
| Baseline (Day 1) up to 10 Weeks |
| Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values | Number of participants with clinically significant change from baseline in laboratory parameters were reported. Clinical Significance was decided by the investigator. Laboratory investigation included hematology, biochemistry, urinalysis, and coagulation. | Baseline (Day 1) up to 10 Weeks |
| Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG) | Number of participants with clinically significant change from baseline in ECG parameters were reported. Clinical Significance was decided by the investigator. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula. | Baseline (Day 1) up to 10 Weeks |
| Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs | Number of participants with clinically significant change from baseline in vital signs. Clinical Significance was decided by the investigator. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. | Baseline (Day 1) up to 10 Weeks |
| Total Body Clearance of Drug From Plasma (CL/f) for Tepotinib | CL/f following oral administration was calculated as Dose/AUC0-inf, where AUC0-inf calculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastcalc/λz, where Clastcalc was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLOQ and λz was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve. | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
| Apparent Volume of Distribution (Vz/f) for Tepotinib | Vz/F was defined as the apparent volume of distribution during the terminal phase following extravascular administration. | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
| Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib | The time to reach the maximum observed plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
| Apparent Terminal Half-Life (t1/2) of Tepotinib 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. | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Tepotinib |
Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 1. |
| OG001 | Tepotinib Then Carbamazepine | Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32. |
|
|
| Primary | Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Measurable Concentration (AUC0-tlast) of Tepotinib | The AUC from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down). | PK analysis set included all participants who had administered any dose of any study intervention and completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = overall number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Tepotinib | Cmax was obtained directly from the concentration versus time curve. | PK analysis set included all participants who had administered any dose of any study intervention and completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = overall number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per mililiter (ng/mL) | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAES With Severity of Grade Greater or Equal to 3 | 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. Severity of abnormalities were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version [24.1]. grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE | Safety Analysis Set included all participants, who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Baseline (Day 1) up to 10 Weeks |
|
|
|
| Secondary | Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values | Number of participants with clinically significant change from baseline in laboratory parameters were reported. Clinical Significance was decided by the investigator. Laboratory investigation included hematology, biochemistry, urinalysis, and coagulation. | The safety analysis set included all participants who had received any dose of the study medication. | Posted | Count of Participants | Participants | Baseline (Day 1) up to 10 Weeks |
|
|
|
| Secondary | Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG) | Number of participants with clinically significant change from baseline in ECG parameters were reported. Clinical Significance was decided by the investigator. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula. | The safety analysis set included all participants who had received any dose of the study medication. | Posted | Count of Participants | Participants | Baseline (Day 1) up to 10 Weeks |
|
|
|
| Secondary | Number of Participants With Clinically Meaningful Change From Baseline in Vital Signs | Number of participants with clinically significant change from baseline in vital signs. Clinical Significance was decided by the investigator. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. | The safety analysis set included all participants who had received any dose of the study medication. | Posted | Count of Participants | Participants | Baseline (Day 1) up to 10 Weeks |
|
|
|
| Secondary | Total Body Clearance of Drug From Plasma (CL/f) for Tepotinib | CL/f following oral administration was calculated as Dose/AUC0-inf, where AUC0-inf calculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastcalc/λz, where Clastcalc was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLOQ and λz was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve. | PK analysis set included all participants who had administered any dose of any study intervention and completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = overall number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter/hour | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/f) for Tepotinib | Vz/F was defined as the apparent volume of distribution during the terminal phase following extravascular administration. | PK analysis set included all participants who had administered any dose of any study intervention and completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = overall number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
|
|
|
| Secondary | Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib | The time to reach the maximum observed plasma concentration (Tmax) was obtained directly from the concentration versus time curve. | PK analysis set included all participants who had administered any dose of any study intervention and completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = overall number of participants evaluable for this outcome measure. | Posted | Median | Full Range | Hours | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
|
|
|
| Secondary | Apparent Terminal Half-Life (t1/2) of Tepotinib 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. | PK analysis set included all participants who had administered any dose of any study intervention and completed the study without any relevant protocol deviations and factors likely to affect the comparability of PK results. Here 'Overall number of participants analyzed' = overall number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Predose 60 minutes before tepotinib dosing and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 30, 38, 48, 60, 72, 96, 120, 144, and 168 hours post dose. Predose 60 minutes before carbamazepine dosing and 1, 1.5, 2, 3, 4, 6, and 8 hours post dose |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 7 |
| 18 |
| EG001 | Carbamazepine | Carbamazepine 100 mg twice daily at Day 8 and 9, 200 mg twice daily at Day 10 and 11, 300 mg twice daily from Day 12 to 25. | 0 | 14 | 0 | 14 | 13 | 14 |
| EG002 | Tepotinib Then Carbamazepine | Participants received a single oral dose of Tepotinib 500 milligrams (mg) on Day 26 under fed state followed by Carbamazepine, 300 mg twice daily from Day 26 to 32. | 0 | 14 | 0 | 14 | 7 | 14 |
| Feeling drunk | General disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Muscle hypertrophy | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Coagulation |
|