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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513624-42-00 | EU Trial (CTIS) Number |
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This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option.
The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1/Part 2 - Vimseltinib/Vimseltinib | Experimental | Participants received blinded treatment of 30 mg twice a week (BIW) vimseltinib for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2. |
|
| Part 1/Part 2: Placebo/Vimseltinib | Placebo Comparator | Participants received blinded treatment of BIW matching placebo for 24 weeks in Part 1 and open-label 30 mg BIW vimseltinib in Part 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vimseltinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | ORR was assessed by blinded independent radiologic review (IRR) using RECIST Version 1.1. ORR was defined as the percentage of participants who achieved either complete response (CR) or partial response (PR).
| Baseline to Week 25 (Cycle 7, Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR at Week 25 Per Tumor Volume Score (TVS) | TVS is a semi-quantitative magnetic resonance imaging (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. ORR was the percentage of participants who achieved either CR or PR as assessed by blinded IRR using TVS.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| UC Davis Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38843860 | Derived | Gelderblom H, Bhadri V, Stacchiotti S, Bauer S, Wagner AJ, van de Sande M, Bernthal NM, Lopez Pousa A, Razak AA, Italiano A, Ahmed M, Le Cesne A, Tinoco G, Boye K, Martin-Broto J, Palmerini E, Tafuto S, Pratap S, Powers BC, Reichardt P, Casado Herraez A, Rutkowski P, Tait C, Zarins F, Harrow B, Sharma MG, Ruiz-Soto R, Sherman ML, Blay JY, Tap WD; MOTION investigators. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2709-2719. doi: 10.1016/S0140-6736(24)00885-7. Epub 2024 Jun 3. | |
| 37593881 |
Not provided
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Presented here is data from the Week 25 primary endpoint analysis. The study is ongoing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1/Part 2: Vimseltinib/Vimseltinib | Participants received blinded treatment of vimseltinib 30 milligrams (mg) twice a week (BIW) for 24 weeks in Part 1 and open-label vimseltinib 30 mg BIW in Part 2 until end of treatment (EoT). |
| FG001 | Part 1/Part 2: Placebo/Vimseltinib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Double Blind (Weeks 1 - 24) |
|
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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 | May 31, 2023 | Jan 2, 2025 |
Not provided
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| Placebo | Drug | Administered orally |
|
| Baseline to Week 25 (Cycle 7, Day 1) |
| Change From Baseline in Active Range of Motion (ROM) at Week 25 | Presented here is the change from baseline in active ROM to Week 25. Measurement of the affected and contralateral, non-affected joint was assessed by goniometer and measured in degrees. At baseline, the motion with the smallest relative ROM value (worst) was identified, and this motion was used for evaluating the change in relative ROM subsequently. The affected joint measurement was used to derive a relative ROM based on active measurement relative to reference standard value provided by the American Medical Association. Relative ROM is expressed in percent: 100 x (joint ROM measure)/(reference ROM standard). | Baseline to Week 25 (Cycle 7, Day 1) |
| Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25 | All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes. | Baseline to Week 25 (Cycle 7, Day 1) |
| Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25 | The Worst Stiffness NRS is a single question that asks the participant to assess their worst stiffness in the last 24 hours. Participants rate their worst stiffness on a scale of 0 to 10, where 0 is "no stiffness" and 10 is "worst imaginable." Lower scores represented better level of stiffness. | Baseline to Week 25 (Cycle 7, Day 1) |
| Change From Baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25 | The EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical VAS scale ranging from a minimum of 0 (worst imaginable health state) to a maximum of 100 (best imaginable health state). Higher scores indicated better health state. | Baseline to Week 25 (Cycle 7, Day 1) |
| Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use | Participants reported responses to the BPI Worst Pain NRS. The BPI Worst Pain NRS ranged from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine." A responder was defined as a participant who: (i) experienced a decrease of at least 30% in the mean BPI Worst Pain NRS item and (ii) did not experience a 30% or greater increase in narcotic analgesic use. | Baseline to Week 25 (Cycle 7, Day 1) |
| Sacramento |
| California |
| 95817 |
| United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Kansas | Kansas City | Kansas | 66160 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10016 | United States |
| Duke Sarcoma Research | Durham | North Carolina | 27710 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Chris O'Brien Lifehouse | Camperdown | Australia |
| McGill University | Montreal | Canada |
| Princess Margaret Hospital | Toronto | Canada |
| Institut Bergonié | Bordeaux | France |
| Centre Léon Bérard | Lyon | France |
| Institut Gustave Roussy | Villejuif | France |
| Helios Klinikum Berlin-Buch | Berlin | Germany |
| University Hospital Essen (Universitätsklinikum Essen) | Essen | Germany |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Istituto Ortopedico Rizzoli | Bologna | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" | Naples | Italy |
| Istituto Oncologico Veneto | Padua | Italy |
| Istituto Nazionale Tumori Regina Elena | Rome | Italy |
| Leiden University Medical Center | Leiden | Netherlands |
| Oslo University Hospital | Oslo | Norway |
| Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy | Warsaw | Poland |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| Fundacion Jimenez Diaz | Madrid | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Universitäts-Kinderspital beider Basel (UKBB) | Basel | Switzerland |
| Cancer & Haematology Centre, The Churchill Hospital - Oxford University Hospitals NHS Foundation Trust | London | United Kingdom |
| University College London Hospitals | London | United Kingdom |
| Derived |
| Tap WD, Sharma MG, Vallee M, Smith BD, Sherman ML, Ruiz-Soto R, de Sande MV, Randall RL, Bernthal NM, Gelderblom H. The MOTION study: a randomized, phase III study of vimseltinib for the treatment of tenosynovial giant cell tumor. Future Oncol. 2024 Mar;20(10):593-601. doi: 10.2217/fon-2023-0238. Epub 2023 Aug 18. |
Participants received blinded treatment of matching placebo BIW for 24 weeks in Part 1 and open-label vimseltinib 30 mg BIW in Part 2 until EoT. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED | One participant was continuing in Part 1 of study at time of primary endpoint analysis. |
|
| NOT COMPLETED |
|
|
| Part 2: Open Label (Weeks 25 - EoS) |
|
|
The Intent-to-Treat (ITT) Set consisted of participants who were randomized to a study treatment regimen. Presented here are data from Part 1 baseline period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1/Part 2: Vimseltinib/Vimseltinib | Participants received blinded treatment of vimseltinib 30 mg BIW for 24 weeks in Part 1 and open-label vimseltinib 30 mg BIW in Part 2 until EoT. |
| BG001 | Part 1/Part 2: Placebo/Vimseltinib | Participants received blinded treatment of matching placebo BIW for 24 weeks in Part 1 and open-label vimseltinib 30 mg BIW in Part 2 until end of EoT. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Objective Response Rate (ORR) at Week 25 Per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 | ORR was assessed by blinded independent radiologic review (IRR) using RECIST Version 1.1. ORR was defined as the percentage of participants who achieved either complete response (CR) or partial response (PR).
| The ITT Set consisted of participants who were randomized to a study treatment regimen. | Posted | Number | 95% Confidence Interval | percentage of participants with CR or PR | Baseline to Week 25 (Cycle 7, Day 1) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ORR at Week 25 Per Tumor Volume Score (TVS) | TVS is a semi-quantitative magnetic resonance imaging (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. ORR was the percentage of participants who achieved either CR or PR as assessed by blinded IRR using TVS.
| The ITT Set consisted of participants who were randomized to a study treatment regimen. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Week 25 (Cycle 7, Day 1) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Active Range of Motion (ROM) at Week 25 | Presented here is the change from baseline in active ROM to Week 25. Measurement of the affected and contralateral, non-affected joint was assessed by goniometer and measured in degrees. At baseline, the motion with the smallest relative ROM value (worst) was identified, and this motion was used for evaluating the change in relative ROM subsequently. The affected joint measurement was used to derive a relative ROM based on active measurement relative to reference standard value provided by the American Medical Association. Relative ROM is expressed in percent: 100 x (joint ROM measure)/(reference ROM standard). | The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point. | Posted | Least Squares Mean | Standard Error | Change in percent | Baseline to Week 25 (Cycle 7, Day 1) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25 | All participants were asked 15 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." Total scores were converted to T-scores that ranged from 0 to 100, with higher scores representing less physical function interference and better health outcomes. | The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 25 (Cycle 7, Day 1) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25 | The Worst Stiffness NRS is a single question that asks the participant to assess their worst stiffness in the last 24 hours. Participants rate their worst stiffness on a scale of 0 to 10, where 0 is "no stiffness" and 10 is "worst imaginable." Lower scores represented better level of stiffness. | The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 25 (Cycle 7, Day 1) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQoL Visual Analogue Scale (EQ-VAS) at Week 25 | The EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical VAS scale ranging from a minimum of 0 (worst imaginable health state) to a maximum of 100 (best imaginable health state). Higher scores indicated better health state. | The ITT Set consisted of participants who were randomized to a study treatment regimen. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure at the specified time point. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 25 (Cycle 7, Day 1) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Response at Week 25 Based on Brief Pain Inventory (BPI) Worst Pain NRS Score and Narcotic Analgesic Use | Participants reported responses to the BPI Worst Pain NRS. The BPI Worst Pain NRS ranged from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine." A responder was defined as a participant who: (i) experienced a decrease of at least 30% in the mean BPI Worst Pain NRS item and (ii) did not experience a 30% or greater increase in narcotic analgesic use. | The ITT Set consisted of participants who were randomized to a study treatment regimen. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Week 25 (Cycle 7, Day 1) |
|
|
Collection of adverse events started from the signing of informed consent through safety follow-up (up to 1.68 years)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total - Vimseltinib | Participants received blinded treatment of vimseltinib 30 mg BIW for 24 weeks in Part 1 and/or open-label vimseltinib 30 mg BIW in Part 2 until EoT. | 1 | 118 | 17 | 118 | 113 | 118 |
| EG001 | Placebo | Participants received blinded treatment of matching placebo BIW for 24 weeks. | 0 | 39 | 1 | 39 | 32 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials | Deciphera Pharmaceuticals, LLC | 785-830-2100 | clinicaltrials@deciphera.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2023 | Jan 2, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000070779 | Giant Cell Tumor of Tendon Sheath |
| D013586 | Synovitis, Pigmented Villonodular |
| ID | Term |
|---|---|
| D005870 | Giant Cell Tumors |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013585 | Synovitis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
Not provided
Not provided
| Lost to Follow-up |
|
| Ongoing in study |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Counts |
|---|
| Participants |
|
|
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| Participants |
|
|
|
|
|
|
|
|
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