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| ID | Type | Description | Link |
|---|---|---|---|
| Ruxolitinib | Other Identifier | Incyte Corporation | |
| 2008-001382-28 | EudraCT Number |
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Termination of the clinical trial by sponsor.
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To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group were refractory to hydroxyurea or for whom hydroxyurea is contraindicated.
The study consisted of a 2-stage design, which included a dose-ranging phase (during which patients received treatment at their randomized dose) and an expansion phase (after adjustment of dose/regimen to achieve an optimal balance of efficacy and safety). During the dose-ranging phase, patients in each disease group (PV or ET) were randomly assigned in a 1:1:1 ratio independent of each other to receive 1 of 3 treatment regimens with Ruxolitinib, 10 mg twice daily (bid), 25 mg bid, or 50 mg once daily (qd). After patients completed 2 cycles of treatment with Ruxolitinib at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis using their discretion in order to achieve an optimal balance of efficacy and safety. During the expansion phase (ie, after optimization of dose), additional patients with PV or ET were enrolled to receive Ruxolitinib at the dose that was selected upon review of data from the dose-ranging phase. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib 10 mg BID | Experimental | Participants received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
|
| Ruxolitinib 25 mg BID | Experimental | Participants received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
|
| Ruxolitinib 50 mg QD | Experimental | Participants received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib was administered orally and supplied as 5 mg and 25 mg tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | For a confirmed response all criteria must have been sustained for at least 2 months. CR:
PR:
| Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3 |
| Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | For a confirmed response all criteria must have been sustained for at least 2 months. Complete Clinical Response:
Partial Clinical Response:
| Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | The individual components of clinical response included:
| Baseline and Week 12 (Cycle 4, Day 1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
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Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Albert Assad, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston | Texas | 77030 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25999444 | Derived | Pieri L, Pancrazzi A, Pacilli A, Rabuzzi C, Rotunno G, Fanelli T, Guglielmelli P, Fjerza R, Paoli C, Verstovsek S, Vannucchi AM. JAK2V617F complete molecular remission in polycythemia vera/essential thrombocythemia patients treated with ruxolitinib. Blood. 2015 May 21;125(21):3352-3. doi: 10.1182/blood-2015-01-624536. No abstract available. |
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This was a multicenter study with 2 sites in the United States and 4 sites in Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Polycythemia Vera (PV): Ruxolitinib 10 mg BID | Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| FG001 | PV: Ruxolitinib 25 mg BID | Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| FG002 | PV: Ruxolitinib 50 mg QD | Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| FG003 | Essential Thrombocythemia (ET): Ruxolitinib 10 mg BID | Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| FG004 | ET: Ruxolitinib 25 mg BID | Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| FG005 | ET: Ruxolitinib 50 mg QD | Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| FG006 | PV: Ruxolitinib All Doses Combined- Expansion Phase | After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 10 mg BID for subjects with PV. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety. |
| FG007 | ET: Ruxolitinib All Doses Combined-expansion Phase | After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 25 mg BID for subjects with ET. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Phase (Dose-finding) |
|
| ||||||||||||||||||||||||
| Expansion Phase |
|
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PV: Ruxolitinib 10 mg BID | Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| 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 | Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | For a confirmed response all criteria must have been sustained for at least 2 months. CR:
PR:
| Polycythemia Vera intent to treat population, including all patients who took at least 1 dose of study drug. | Posted | Number | percentage of participants | Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3 |
|
From start of study up to data cutoff at 20 June 2018; approximately 9 years.
Safety evaluable PV and ET participants.The safety evaluable population included all enrolled participants who received at lease 1 dose of study drug.
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 | PV: Ruxolitinib 10 mg BID | Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
Not provided
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | The individual components of clinical response included:
| Baseline and Week 24 (Cycle 7, Day 1) |
| Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | The individual components of clinical response included:
| Baseline and Week 36 (Cycle 10, Day 1) |
| Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks | The individual components of clinical response included:
| Baseline and 4 weeks (Cycle 2, Day 1) |
| Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | The individual components of clinical response included:
| Baseline and 24 weeks (Cycle 7, Day 1) |
| Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | The individual components of clinical response included:
| Baseline and 36 weeks (Cycle 10, Day 1) |
| Change From Baseline to Week 4 in Polycythemia Vera Symptoms | Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats. | Baseline and Week 4 (Cycle 2, Day 1) |
| Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms | Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness. | Baseline and Week 4 (Cycle 2, Day 1) |
| Change From Baseline to Week 4 in Health-related Quality of Life | Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life. | Baseline and Week 4 (Cycle 2, Day 1) |
| Bergamo |
| Italy |
| Florence | Italy |
| Pavia | Italy |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Disease progression |
|
| Termination of the trial by sponsor |
|
| Per Investigator: lack of response |
|
| Unspecified reason |
|
| Safety Evaluable Participants |
|
| ITT Participants |
|
| COMPLETED | Participants ongoing: last patient last visit (LPLV) occurred 20AUG2018 following the data cutoff. |
|
| NOT COMPLETED |
|
|
| BG001 | PV: Ruxolitinib 25 mg BID | Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| BG002 | PV: Ruxolitinib 50 mg QD | Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| BG003 | ET: Ruxolitinib 10 mg BID | Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| BG004 | ET: Ruxolitinib 25 mg BID | Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| BG005 | ET: Ruxolitinib 50 mg QD | Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Hematocrit | Number | participants |
|
| Platelet count | Number | participants |
|
| White blood cell count | Number | participants |
|
Participants with Polycythemia Vera received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| OG001 | PV: Ruxolitinib 25 mg BID | Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| OG002 | PV: Ruxolitinib 50 mg QD | Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
|
|
| Secondary | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks | The individual components of clinical response included:
| Polycythemia Vera intent to treat population for whom data was available. | Posted | Number | percentage of participants | Baseline and Week 12 (Cycle 4, Day 1) |
|
|
|
| Primary | Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) | For a confirmed response all criteria must have been sustained for at least 2 months. Complete Clinical Response:
Partial Clinical Response:
| Essential thrombocythemia intent to treat population, including all patients who took at least 1 dose of study drug. One patient in the 50 mg QD group did not have a response assessment at Cycle 3, Day 1. | Posted | Number | percentage of participants | Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3. |
|
|
|
| Secondary | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | The individual components of clinical response included:
| Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component. | Posted | Number | percentage of participants | Baseline and Week 24 (Cycle 7, Day 1) |
|
|
|
| Secondary | Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | The individual components of clinical response included:
| Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component. | Posted | Number | percentage of participants | Baseline and Week 36 (Cycle 10, Day 1) |
|
|
|
| Secondary | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks | The individual components of clinical response included:
| Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component. | Posted | Number | percentage of participants | Baseline and 4 weeks (Cycle 2, Day 1) |
|
|
|
| Secondary | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks | The individual components of clinical response included:
| Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component. | Posted | Number | percentage of participants | Baseline and 24 weeks (Cycle 7, Day 1) |
|
|
|
| Secondary | Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks | The individual components of clinical response included:
| Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component. | Posted | Number | percentage of participants | Baseline and 36 weeks (Cycle 10, Day 1) |
|
|
|
| Secondary | Change From Baseline to Week 4 in Polycythemia Vera Symptoms | Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats. | Polycythemia Vera intent to treat population who had symptom scores > 0 at baseline for whom data was available. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 4 (Cycle 2, Day 1) |
|
|
|
| Secondary | Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms | Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms. For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness. | Essential Thrombocythemia intent to treat population who had symptom scores > 0 at baseline and for whom data was available. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 4 (Cycle 2, Day 1) |
|
|
|
| Secondary | Change From Baseline to Week 4 in Health-related Quality of Life | Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life. | Intent to treat population. The intent-to-treat (ITT) population included all subjects who took at least 1 dose of study drug. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 4 (Cycle 2, Day 1) |
|
|
|
| 2 |
| 19 |
| 19 |
| 19 |
| EG001 | PV: Ruxolitinib 25 mg BID | Participants with Polycythemia Vera received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. | 2 | 8 | 8 | 8 |
| EG002 | PV: Ruxolitinib 50 mg QD | Participants with Polycythemia Vera received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. | 1 | 7 | 7 | 7 |
| EG003 | ET: Ruxolitinib 10 mg BID | Participants with Essential Thrombocythemia received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. | 1 | 8 | 8 | 8 |
| EG004 | ET: Ruxolitinib 25 mg BID | Participants with Essential Thrombocythemia received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. | 1 | 22 | 22 | 22 |
| EG005 | ET: Ruxolitinib 50 mg QD | Participants with Essential Thrombocythemia received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. | 3 | 9 | 8 | 9 |
| EG006 | PV: Ruxolitinib All Doses Combined- Expansion Phase | After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 10 mg BID for subjects with PV. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety. | 17 | 34 | 34 | 34 |
| EG007 | ET: Ruxolitinib All Doses Combined-expansion Phase | After the completion of the dose-finding phase of the study, the starting dose of ruxolitinib for the expansion phase was determined to be 25 mg BID for subjects with ET. After subjects completed 8 weeks of ruxolitinib treatment at the starting dose, investigators were permitted to adjust the dose regimen to a maximum total daily dose of 75 mg on an individual basis, using their discretion, in order to achieve an optimal balance of efficacy and safety. | 17 | 39 | 39 | 39 |
| Atrial flutter | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastric varices haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Squamous cell carcinoma of the oral cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Tongue cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Small intestine ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Drug withdrawal syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumococcal bacteraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Osteitis deformans | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Paget's disease of the vulva | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myodesopsia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dental discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Perineurial cyst | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Mucocutaneous rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood glucose decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| thyroid mass | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Serum ferritin decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study; provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
|
| 50% reduction in spleen size |
|
| Platelet count ≤ 400 x 10^9/L |
|
| WBC count ≤ 10 x 10^9/L |
|
| Absence of palpable splenomegaly |
|
|
| 50% reduction in spleen size |
|
|
| Platelet count ≤ 400 x 10^9/L |
|
|
| WBC count ≤ 10 x 10^9/L |
|
|
| Absence of palpable splenomegaly |
|
|
| 50% reduction in spleen size |
|
|
| Platelet count ≤ 400 x 10^9/L |
|
|
| WBC count ≤ 10 x 10^9/L |
|
|
| WBC count ≤ 10 x 10^9/L |
|
|
| 50% reduction in spleen size |
|
|
| Absence of palpable splenomegaly |
|
|
| WBC count ≤ 10 x 10^9/L |
|
|
| 50% reduction in spleen size |
|
|
| Absence of palpable splenomegaly |
|
|
| WBC count ≤ 10 x 10^9/L |
|
|
| 50% reduction in spleen size |
|
|
| Absence of palpable splenomegaly |
|
|
| Bone pain |
|
|
| Fever |
|
|
| Night sweats |
|
|
| Night Sweats |
|
|
| Weakness |
|
|
| Bone pain |
|
|
| Paresthesia |
|
|