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This study will assess pexidartinib in adult participants with symptomatic TGCT that is associated with severe morbidity or functional limitations and not amendable to improvement with surgery.
Participants with symptomatic TGCT will be administered pexidartinib 400 mg twice daily continuously with 28-day treatment cycle until criteria for discontinuation are reached. Participants who complete primary endpoint assessments may be eligible to continue receiving pexidartinib until disease progression, unacceptable toxicity, the occurrence of other termination criteria, or withdrawal from the study. Eligible participants' status will be collected every 6 months as a long term follow-up at least 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pexidartinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pexidartinib | Drug | 400 mg twice daily for a total daily dose of 800 mg (each capsule contains 200 mg of pexidartinib for oral administration) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) of Pexidartinib Based on RECIST 1.1 of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25 | For the assessment of tumor response, participants were classified into the best of the following tumor response categories based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by centrally reviewed MRI scan. Complete response (CR), disappearance of all target lesions and normalization of tumor marker level; partial response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; and overall response rate (ORR), defined as CR+PR, are presented. | At Week 25 postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) of Pexidartinib Based on TVS of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25 | For the assessment of tumor response, participants were classified into the best of the following tumor response categories based on Tumor Volume Score (TVS) by centrally reviewed MRI scan. Tumor Volume Score (TVS) is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. Complete response (CR), disappearance of lesion; partial response (PR), at least 50% decrease in volume score relative to baseline; overall response rate (ORR), defined as CR+PR, are presented. |
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Inclusion Criteria:
Age ≥ 18 years (Age ≥ 20 years in Taiwan).
A diagnosis of TGCT (i) that has been histologically confirmed by a pathologist and (ii) associated with severe morbidity or functional limitations and not amenable to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board).
Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist.
Stable prescription of analgesic regimen during the 2 weeks prior to enrollment.
Women of childbearing potential must have a negative serum pregnancy test within the 14-day period prior to enrollment (Where demanded by local regulations, this test may be required within 72 hours of enrollment).
Females of reproductive potential should be advised to use an effective, non-hormonal method of contraception during treatment with pexidartinib and for 1 month after the last dose. Males with female partners of reproductive potential should be advised to use an effective method of contraception during treatment with pexidartinib and for 1 month after the last dose. Female partners of male participants should concurrently use effective contraceptive methods (hormonal or non-hormonal). Women of nonchildbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year. Women who have documentation of at least 12 months of spontaneous amenorrhea and have a follicle stimulating hormone level > 40 mIU/mL will be considered postmenopausal.
Adequate hematologic, hepatic, and renal function, defined by:
Willingness and ability to complete the PROMIS Physical Function Scale.
Willingness and ability to use a diary.
Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ji Shui Tan Hospital | Beijing | China | ||||
| Peking University Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40841499 | Derived | Xu H, Wu PK, Ye Z, Fan Z, Li T, Chen TW, Shen J, Yan W, Achiwa I, Yoh K, Kikumori K, Hiruma Y, Greenberg J, Niu X. A Phase 3 Study of the Efficacy and Safety of Pexidartinib in East Asian Patients with Tenosynovial Giant Cell Tumor. Oncol Ther. 2025 Dec;13(4):1025-1039. doi: 10.1007/s40487-025-00365-z. Epub 2025 Aug 21. |
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De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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A total of 40 participants who met all inclusion criteria and no exclusion criteria were enrolled and treated at clinic centers in China and Taiwan. Primary results reported are from baseline up to data cut-off date of 27 Oct 2021. The results presented are based on primary analysis. Data collection is still on-going and additional results will be provided after study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pexidartinib | Participants who received pexidartinib 400mg twice daily (BID) for a total daily dose of 800 mg (2 capsules in the morning and 2 capsules in the evening). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics were assessed in the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pexidartinib | Participants who received pexidartinib 400mg twice daily (BID) for a total daily dose of 800 mg (2 capsules in the morning and 2 capsules in the evening). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Overall Response Rate (ORR) of Pexidartinib Based on RECIST 1.1 of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25 | For the assessment of tumor response, participants were classified into the best of the following tumor response categories based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by centrally reviewed MRI scan. Complete response (CR), disappearance of all target lesions and normalization of tumor marker level; partial response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; and overall response rate (ORR), defined as CR+PR, are presented. | ORR based on RECIST 1.1 was assessed in the Full Analysis Set. | Posted | Count of Participants | Participants | At Week 25 postdose |
|
Adverse events (AE) were collected from the date of signing the informed consent form up post-treatment visit (28 ± 7 days after the last dose of study drug), up 13 months.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until post-treatment visit (28 ± 7 days after the last dose of study drug).
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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 | Pexidartinib | Participants who received pexidartinib 400mg twice daily (BID) for a total daily dose of 800 mg (2 capsules in the morning and 2 capsules in the evening). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hair color changes | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Daiichi Sankyo, Inc. | 908-992-6400 | CTRinfo@dsi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2021 | Feb 21, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070779 | Giant Cell Tumor of Tendon Sheath |
| ID | Term |
|---|---|
| D005870 | Giant Cell Tumors |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000600259 | pexidartinib |
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| At Week 25 postdose |
| Mean Percent Change From Baseline for Range of Motion (ROM) Score in Participants Receiving Pexidartinib | Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. The relative ROM was calculated (expressed in percent) as follows: Relative ROM = 100 x (absolute ROM measured)/(reference ROM standard). The change from baseline in relative ROM at Week 25 was calculated as the difference in relative ROM at Week 25 visit minus relative ROM at Screening visit. | At Week 25 postdose |
| Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib | The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess the physical function of the upper and lower limbs. The scale ranges from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes. | At Week 25 postdose |
| Best Overall Response of Pexidartinib Based on RECIST 1.1 and TVS by Centrally Reviewed MRI Scan | Best overall response (CR or PR) of pexidartinib based on RECIST 1.1 and TVS are summarized. Tumor categories for RECIST v1.1 were as follows: complete response (CR), disappearance of all target lesions; partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; progressive disease (PD), at least a 20% increase in the sum of diameters of target lesions; and not evaluable (NE). Tumor categories for TVS were as follows: complete response (CR), disappearance of all target lesions; partial response (PR), at least a 50% decrease in volume score relative to baseline; stable disease (SD), does not meet any of the prior criteria based on score during study; progressive disease (PD), at least a 30% increase in in volume relative to lowest score during the study whether at baseline or some other visit; and not evaluable (NE). | From baseline until disease progression or death (whichever occurs first), up to approximately 29 months |
| Duration of Response of Pexidartinib Based on RECIST 1.1 and TVS by Centrally Reviewed MRI Scan | Duration of response (DOR) is defined as the date of the first recorded response to the first date of documented disease progression. | Time from the date of first documented response until documented disease progression or death from any cause (whichever occurs first), up to approximately 29 months |
| Number of Participants Reporting Frequent (≥10%) Treatment-Emergent Adverse Events by Preferred Term | A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until post-treatment visit (28 ± 7 days after the last dose of study drug). | Up to approximately 29 months |
| Area Under the Plasma Concentration Time Curve From Time 0 to 6 Hours AUC(0-6h) in Participants Receiving Pexidartinib | AUC(0-6h) was calculated using standard non-compartmental analysis. AUC(0-6h) for Pexidartinib and primary metabolite, ZAAD-1006a, are presented. | Week 3: Cycle 1 Day 1 at pre-dose, 0.5h, 1h, 2h, 4h, and 6h post-dose (each cycle is 28 days) |
| Maximum Plasma Concentration (Cmax) in Participants Receiving Pexidartinib | Cmax was calculated using standard non-compartmental analysis. Cmax for Pexidartinib and primary metabolite, ZAAD-1006a, are presented. | Week 3: Cycle 1 Day 1 at pre-dose, 0.5h, 1h, 2h, 4h, and 6h post-dose (each cycle is 28 days) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Participants Receiving Pexidartinib | Tmax was calculated using standard non-compartmental analysis. Tmax for Pexidartinib and primary metabolite, ZAAD-1006a, are presented. | Week 3: Cycle 1 Day 1 at pre-dose, 0.5h, 1h, 2h, 4h, and 6h post-dose (each cycle is 28 days) |
| Beijing |
| China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| Zhejiang Cancer Hospital | Hangzhou | China |
| Fudan University Shanghai Cancer Center | Shanghai | China |
| Shanghai General Hospital | Shanghai | China |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Overall Response Rate (ORR) of Pexidartinib Based on TVS of Asian Participants With Symptomatic Tenosynovial Giant Cell Tumor (TGCT) at Week 25 | For the assessment of tumor response, participants were classified into the best of the following tumor response categories based on Tumor Volume Score (TVS) by centrally reviewed MRI scan. Tumor Volume Score (TVS) is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. Complete response (CR), disappearance of lesion; partial response (PR), at least 50% decrease in volume score relative to baseline; overall response rate (ORR), defined as CR+PR, are presented. | ORR based on TVS was assessed in the Full Analysis Set. | Posted | Count of Participants | Participants | At Week 25 postdose |
|
|
|
| Secondary | Mean Percent Change From Baseline for Range of Motion (ROM) Score in Participants Receiving Pexidartinib | Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. The relative ROM was calculated (expressed in percent) as follows: Relative ROM = 100 x (absolute ROM measured)/(reference ROM standard). The change from baseline in relative ROM at Week 25 was calculated as the difference in relative ROM at Week 25 visit minus relative ROM at Screening visit. | Mean Percent Change From Baseline for Range of Motion (ROM) was assessed in Full Analysis Set; however, participant assessments falling outside the visit window were excluded from the change from baseline analysis. | Posted | Least Squares Mean | Standard Deviation | Percent Change | At Week 25 postdose |
|
|
|
| Secondary | Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib | The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess the physical function of the upper and lower limbs. The scale ranges from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes. | Mean Change From PROMIS was assessed in the Full Analysis Set; however, participant assessments falling outside the visit window were excluded from the change from baseline analysis. | Posted | Least Squares Mean | Standard Deviation | Score on a scale | At Week 25 postdose |
|
|
|
| Secondary | Best Overall Response of Pexidartinib Based on RECIST 1.1 and TVS by Centrally Reviewed MRI Scan | Best overall response (CR or PR) of pexidartinib based on RECIST 1.1 and TVS are summarized. Tumor categories for RECIST v1.1 were as follows: complete response (CR), disappearance of all target lesions; partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease; progressive disease (PD), at least a 20% increase in the sum of diameters of target lesions; and not evaluable (NE). Tumor categories for TVS were as follows: complete response (CR), disappearance of all target lesions; partial response (PR), at least a 50% decrease in volume score relative to baseline; stable disease (SD), does not meet any of the prior criteria based on score during study; progressive disease (PD), at least a 30% increase in in volume relative to lowest score during the study whether at baseline or some other visit; and not evaluable (NE). | Not Posted | Feb 2027 | From baseline until disease progression or death (whichever occurs first), up to approximately 29 months | Participants |
| Secondary | Duration of Response of Pexidartinib Based on RECIST 1.1 and TVS by Centrally Reviewed MRI Scan | Duration of response (DOR) is defined as the date of the first recorded response to the first date of documented disease progression. | Not Posted | Feb 2027 | Time from the date of first documented response until documented disease progression or death from any cause (whichever occurs first), up to approximately 29 months | Participants |
| Secondary | Number of Participants Reporting Frequent (≥10%) Treatment-Emergent Adverse Events by Preferred Term | A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until post-treatment visit (28 ± 7 days after the last dose of study drug). | Not Posted | Feb 2027 | Up to approximately 29 months | Participants |
| Secondary | Area Under the Plasma Concentration Time Curve From Time 0 to 6 Hours AUC(0-6h) in Participants Receiving Pexidartinib | AUC(0-6h) was calculated using standard non-compartmental analysis. AUC(0-6h) for Pexidartinib and primary metabolite, ZAAD-1006a, are presented. | AUC(0-6h) was assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng*h/mL | Week 3: Cycle 1 Day 1 at pre-dose, 0.5h, 1h, 2h, 4h, and 6h post-dose (each cycle is 28 days) |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) in Participants Receiving Pexidartinib | Cmax was calculated using standard non-compartmental analysis. Cmax for Pexidartinib and primary metabolite, ZAAD-1006a, are presented. | Cmax was assessed in the Pharmacokinetic Analysis Set. | Posted | Mean | Standard Deviation | ng/mL | Week 3: Cycle 1 Day 1 at pre-dose, 0.5h, 1h, 2h, 4h, and 6h post-dose (each cycle is 28 days) |
|
|
|
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Participants Receiving Pexidartinib | Tmax was calculated using standard non-compartmental analysis. Tmax for Pexidartinib and primary metabolite, ZAAD-1006a, are presented. | Tmax was assessed in the Pharmacokinetic Analysis Set. | Posted | Median | Full Range | hours | Week 3: Cycle 1 Day 1 at pre-dose, 0.5h, 1h, 2h, 4h, and 6h post-dose (each cycle is 28 days) |
|
|
|
| 0 |
| 40 |
| 6 |
| 40 |
| 40 |
| 40 |
| Fistula inflammation | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Epithelioid sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Skin discoloration | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood cholinesterase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Monocyte count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| High density lipoprotein increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Low density lipoprotein decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Total bile acids increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fatigue | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Swelling face | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Enzyme abnormality | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D013585 | Synovitis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| Title | Measurements |
|---|
|