Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004928-21 | EudraCT Number |
Not provided
Not provided
Unresolvable inability to recruit the patients.
Not provided
Not provided
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Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib | Active Comparator | Two tablets of ruxolitinib 5 mg were administered orally twice per day. |
|
| Ruxolitinib Placebo | Placebo Comparator | Two tablets of 5mg placebo were administered orally twice per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | 5 mg tablet for oral use |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS-1) | Progression free survival (PFS-1) from date of randomization until the occurrence of any of the criteria for disease progression:
| From randomization till disease progression (estimated to be assessed up 48 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Primary Progression (TTP) | TTP is defined as time from randomization until disease progression as defined for PFS-1 excluding death as an event. | From randomization till progression (estimated to be assessed up to 48 months) |
| Percentage Change in Spleen Volume From Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Concord NSW | New South Wales | 2139 | Australia | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Approximately 320 male or female adults (age 18 or over) with a confirmed diagnosis of MF were planned to be enrolled. The target population was not met due to early study termination. A total of 49 subjects were enrolled in the study, 25 in the ruxolitinib arm and 24 in the placebo arm.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib (INC424) | Two tablets of ruxolitinib 5 mg were administered orally twice per day |
| FG001 | Ruxolitinib Placebo | Two tablets of 5mg placebo were administered orally twice per day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2015 | Oct 23, 2018 |
Not provided
Not provided
Not provided
Not provided
| Ruxolitinib Placebo | Drug | 5 mg placebo tablet for oral use |
|
Change in spleen volume (by MRI/CT) from baseline |
| From baseline and assessed on 12 week intervals until end of treatment (EOT) |
| Percentage Change in Symptoms From Baseline Using MF-7 | Percentage change from Baseline in MF-7 total symptom score and 7 individual symptoms at each visit was summarized with descriptive statistics. For this scale, symptoms range from 0 to 10 for the severity experienced within the past 24 hours, with 0 being for absence of symptoms and 10 for worst imaginable symptoms. | From Baseline and assessed every 4 weeks until end of treatment |
| Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | EQ-ED5 profiles were summarized at baseline and at each scheduled assessment for each of the 5 dimensions separately (Mobility, self-care, usual activities, pain discomfort, anxiety/depression) Only participants with baseline score and at least one non-missing post-baseline score during the treatment period were included. Percentages were based on all these evaluable participants. The 5 scores for mobility, self-care, usual activities, pain/discomfort and anxiety/depression are all self-explanatory (eg "I have no problems walking" to "I am unable to walk"), except for the following overall health check, where 100 is the best of health, and 0 is the worst health. | From Baseline and assessed every 4 weeks until end of treatment |
| Overall Survival | To evaluate the effect of ruxolitinib on overall survival | Time from randomization to date of death due to any cause (estimated to be assessed up to 48 months). |
| Plasma Ruxolitinib Concentrations | Characterize pharmacokinetics (PK)by utilizing a population PK approach. | Week 12, Wk 48 |
| Progression Free Survival (PFS-2) | PFS-2 assessed by 25% increase over new baseline of PFS-1 in any of the following: ● Progressive splenomegaly ● 25 % increase in MF-7 score with absolute score ≥ 30 | From date of randomization until second disease progression or death, whichever comes first (estimated to be assessed up to 72 months) |
| Quality-adjusted Life Years From Baseline | EQ-5D-5L (EuroQol-5D-5L, is a standardized instrument for measuring health outcomes, is consists of a descriptive system and a visual analogue scale - scores can be summarized into a single index score that provides a simple measure of health for clinical and economic appraisal ) The EQ-5D-5L health states will be converted into index values (utilities) from which the QALY (Quality - adjusted life years) will be calculated. QALY will be summarized descriptively by treatment arm. | Change from Baseline compared with scheduled study visits at the following intervals every 4 weeks up to week 24, every 8 weeks up to Week 48, every 12 weeks past Wk 48 until End of treatment and 30 day follow up visit |
| Time to First Progressive Splenomegaly (TTPS) | Time to first progressive splenomegaly as determined by spleen volume (by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT). | From randomization until earliest time to progressive splenomegaly (estimated to be assessed up to 48 months) |
| Time to First Symptomatic Progression (TTSP) | Time to first symptomatic progression as determined by Myelofibrosis 7 Item Symptom Scale (MF-7) | From randomization until symptomatic progression (MF-7)(estimated to be assessed up to 48 months) |
| Liverpool |
| New South Wales |
| 2170 |
| Australia |
| Novartis Investigative Site | Wooloongabba | Queensland | 4102 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Salzburg | 5020 | Austria |
| Novartis Investigative Site | Vienna | A-1090 | Austria |
| Novartis Investigative Site | Antwerp | 2060 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | São Paulo | São Paulo | 05403 000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 08270-070 | Brazil |
| Novartis Investigative Site | São Paulo | 01236030 | Brazil |
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada |
| Novartis Investigative Site | Aalborg | DK 9000 | Denmark |
| Novartis Investigative Site | Herlev | DK 2730 | Denmark |
| Novartis Investigative Site | Bayonne | Bayonne Cedex | 64109 | France |
| Novartis Investigative Site | Angers | 49033 | France |
| Novartis Investigative Site | Brest | 29200 | France |
| Novartis Investigative Site | Chambéry | 73011 | France |
| Novartis Investigative Site | Grenoble | 38043 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Nice | 06202 | France |
| Novartis Investigative Site | Rouen | 76038 | France |
| Novartis Investigative Site | Vandœuvre-lès-Nancy | 54511 | France |
| Novartis Investigative Site | Lübeck | Schleswig-Holstein | 23563 | Germany |
| Novartis Investigative Site | Aachen | 52074 | Germany |
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| Novartis Investigative Site | Bonn | 53105 | Germany |
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| Novartis Investigative Site | Dresden | 01307 | Germany |
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| Novartis Investigative Site | Halle S | 06120 | Germany |
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| Novartis Investigative Site | Leipzig | 04103 | Germany |
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| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Athens | GR | 115 27 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 570 10 | Greece |
| Novartis Investigative Site | Athens | 106 76 | Greece |
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| Novartis Investigative Site | Pátrai | 265 00 | Greece |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Budapest | H 1083 | Hungary |
| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Kaposvár | 7400 | Hungary |
| Novartis Investigative Site | Afula | 1834111 | Israel |
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| Novartis Investigative Site | Catania | CT | 95123 | Italy |
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| Novartis Investigative Site | Milan | MI | 20122 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Reggio Emilia | RE | 42123 | Italy |
| Novartis Investigative Site | Orbassano | TO | 10043 | Italy |
| Novartis Investigative Site | Terni | TR | 05100 | Italy |
| Novartis Investigative Site | Varese | VA | 21100 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 453-8511 | Japan |
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| Novartis Investigative Site | Maebashi | Gunma | 371 8511 | Japan |
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| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Novartis Investigative Site | Chūō | Yamanashi | 409-3898 | Japan |
| Novartis Investigative Site | Osaka | 545-8586 | Japan |
| Novartis Investigative Site | Bergen | N-5021 | Norway |
| Novartis Investigative Site | Loerenskog | NO 1478 | Norway |
| Novartis Investigative Site | Lodz | 93-513 | Poland |
| Novartis Investigative Site | Torun | 87 100 | Poland |
| Novartis Investigative Site | Wroclaw | 50 367 | Poland |
| Novartis Investigative Site | Faro | 8000-386 | Portugal |
| Novartis Investigative Site | Porto | 4200-072 | Portugal |
| Novartis Investigative Site | Moscow | 129110 | Russia |
| Novartis Investigative Site | Saint Petersburg | 191024 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194044 | Russia |
| Novartis Investigative Site | Singapore | 119228 | Singapore |
| Novartis Investigative Site | Singapore | 169608 | Singapore |
| Novartis Investigative Site | Cadiz | Andalusia | 11009 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Gothenburg | SE-413 45 | Sweden |
| Novartis Investigative Site | Huddinge | SE-14186 | Sweden |
| Novartis Investigative Site | Lund | SE-221 85 | Sweden |
| Novartis Investigative Site | Uddevalla | 451 80 | Sweden |
| Novartis Investigative Site | Basel | 4031 | Switzerland |
| Novartis Investigative Site | Sankt Gallen | 9001 | Switzerland |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| Novartis Investigative Site | Putzu City | Chiayi Hsien | 61363 | Taiwan |
| Novartis Investigative Site | Kaohsiung City | 83301 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| Novartis Investigative Site | Ankara | 06460 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34890 | Turkey (Türkiye) |
| Novartis Investigative Site | Samsun | 55139 | Turkey (Türkiye) |
| Novartis Investigative Site | Talas / Kayseri | 38039 | Turkey (Türkiye) |
| Novartis Investigative Site | Edgbaston | Birmingham | B15 2GW | United Kingdom |
| Novartis Investigative Site | Westbruy on Trym | Bristol | BS10 5NB | United Kingdom |
| Novartis Investigative Site | Leeds | LS9 7TF | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | Manchester | M20 4BX | United Kingdom |
| Not Treted Wit Study Drug |
|
| Subjects Followed for Survival |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib (INC424) | Two tablets of ruxolitinib 5 mg were administered orally twice per day |
| BG001 | Ruxolitinib Placebo | Two tablets of 5mg placebo were administered orally twice per day |
| 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 | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. | 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 | Progression Free Survival (PFS-1) | Progression free survival (PFS-1) from date of randomization until the occurrence of any of the criteria for disease progression:
| The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that the primary endpoint of PFS and any other time to event endpoint would not be derived. | Posted | From randomization till disease progression (estimated to be assessed up 48 months) |
|
| ||||||||||||||||||||||
| Secondary | Time to Primary Progression (TTP) | TTP is defined as time from randomization until disease progression as defined for PFS-1 excluding death as an event. | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived. | Posted | From randomization till progression (estimated to be assessed up to 48 months) |
|
| ||||||||||||||||||||||
| Secondary | Percentage Change in Spleen Volume From Baseline | Change in spleen volume (by MRI/CT) from baseline | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. | Posted | Mean | Standard Deviation | Percentage change from baseline | From baseline and assessed on 12 week intervals until end of treatment (EOT) |
|
| |||||||||||||||||||
| Secondary | Percentage Change in Symptoms From Baseline Using MF-7 | Percentage change from Baseline in MF-7 total symptom score and 7 individual symptoms at each visit was summarized with descriptive statistics. For this scale, symptoms range from 0 to 10 for the severity experienced within the past 24 hours, with 0 being for absence of symptoms and 10 for worst imaginable symptoms. | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. | Posted | Mean | Standard Deviation | Percentage change in scores | From Baseline and assessed every 4 weeks until end of treatment |
|
| |||||||||||||||||||
| Secondary | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | EQ-ED5 profiles were summarized at baseline and at each scheduled assessment for each of the 5 dimensions separately (Mobility, self-care, usual activities, pain discomfort, anxiety/depression) Only participants with baseline score and at least one non-missing post-baseline score during the treatment period were included. Percentages were based on all these evaluable participants. The 5 scores for mobility, self-care, usual activities, pain/discomfort and anxiety/depression are all self-explanatory (eg "I have no problems walking" to "I am unable to walk"), except for the following overall health check, where 100 is the best of health, and 0 is the worst health. | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. Only the categories with non-zero counts are presented with these results. Only subjects with baseline score and at least one non-missing post-baseline score during the treatment period 1 were included. % is based on all these evaluable subjects. | Posted | Count of Participants | Participants | From Baseline and assessed every 4 weeks until end of treatment |
| |||||||||||||||||||||
| Secondary | Overall Survival | To evaluate the effect of ruxolitinib on overall survival | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived. | Posted | Time from randomization to date of death due to any cause (estimated to be assessed up to 48 months). |
|
| ||||||||||||||||||||||
| Secondary | Plasma Ruxolitinib Concentrations | Characterize pharmacokinetics (PK)by utilizing a population PK approach. | The Pharmacokinetics (PK) Analysis Set (PAS) consisted of all patients set who have received at least one dose of ruxolitinib and provided evaluable PK data. The PK analysis was never done as the study terminated early. | Posted | Week 12, Wk 48 |
|
| ||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS-2) | PFS-2 assessed by 25% increase over new baseline of PFS-1 in any of the following: ● Progressive splenomegaly ● 25 % increase in MF-7 score with absolute score ≥ 30 | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived | Posted | From date of randomization until second disease progression or death, whichever comes first (estimated to be assessed up to 72 months) |
|
| ||||||||||||||||||||||
| Secondary | Quality-adjusted Life Years From Baseline | EQ-5D-5L (EuroQol-5D-5L, is a standardized instrument for measuring health outcomes, is consists of a descriptive system and a visual analogue scale - scores can be summarized into a single index score that provides a simple measure of health for clinical and economic appraisal ) The EQ-5D-5L health states will be converted into index values (utilities) from which the QALY (Quality - adjusted life years) will be calculated. QALY will be summarized descriptively by treatment arm. | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived. | Posted | Change from Baseline compared with scheduled study visits at the following intervals every 4 weeks up to week 24, every 8 weeks up to Week 48, every 12 weeks past Wk 48 until End of treatment and 30 day follow up visit |
| |||||||||||||||||||||||
| Secondary | Time to First Progressive Splenomegaly (TTPS) | Time to first progressive splenomegaly as determined by spleen volume (by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT). | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived. | Posted | From randomization until earliest time to progressive splenomegaly (estimated to be assessed up to 48 months) |
|
| ||||||||||||||||||||||
| Secondary | Time to First Symptomatic Progression (TTSP) | Time to first symptomatic progression as determined by Myelofibrosis 7 Item Symptom Scale (MF-7) | The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived. | Posted | From randomization until symptomatic progression (MF-7)(estimated to be assessed up to 48 months) |
|
|
Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately up to approx. 55.1 weeks.
One subject in the ruxolitinib arm was not treated with the study drug due to subject or guardian's decision post randomization. This subject is included in the FAS but not in the Safety set.
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 | Ruxolitinib (INC424) | Two tablets of ruxolitinib 5 mg were administered orally twice per day | 0 | 24 | 2 | 24 | 17 | 24 |
| EG001 | Ruxolitinib Placebo | Two tablets of 5mg placebo were administered orally twice per day | 0 | 24 | 1 | 24 | 11 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2017 | Oct 23, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Other |
|
| Missing |
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|