Essential Thrombocythemia
Conditions
Brief summary
This is an observational study to explore how different treatment regimens affect continuation with treatment in the first 6 months following initiation of XAGRID into adult patients' essential thrombocythemia therapy.
Interventions
None listed
Sponsors
Shire
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 years and older. 2. High-risk ET Patients, uncontrolled by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons. 3. Patients who have been on second- or third-line XAGRID treatment for up to 1 month, or for whom a decision has been documented to commence second line XAGRID treatment. 4. Patients able to understand and able and willing to participate in the study, and provide a personally dated and signed written informed consent form.
Exclusion criteria
1. Patients with a known or suspected intolerance or hypersensitivity to XAGRID, closely related compounds, or any of the stated ingredients. 2. Patients for whom there is an intention to treat with combinations of cytoreductive therapy. 3. Patients participating in a separate clinical trial where their treatment is defined by that study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) | 6 months | Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases |
| Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases |
| Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases |
| Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases |
| Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases |
| Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation | 6 months | Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases |
| Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation | 6 months | Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases |
| Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy | 6 months | Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases |
| Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) | 6 months | Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases |
| Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | 6 months | — |
| Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases |
| Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases |
| Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases |
| Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases |
| Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) | 6 months | Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases |
| Maximum Daily Dose of Anagrelide Hydrochloride | 6 months | — |
| Percentage of Subjects With Anagrelide Hydrochloride Starting Doses | 6 months | — |
Countries
France
Participant flow
Pre-assignment details
177 subjects were enrolled, but 2 never received Anagrelide Hydrochloride (Xagrid) and were excluded from the trial (n = 175).
Participants by arm
| Arm | Count |
|---|---|
| Anagrelide Hydrochloride The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician. | 175 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Patient did not show up for visits | 1 |
| Overall Study | Patient not visiting hospital regularly | 1 |
| Overall Study | Patient seen in different hospital | 1 |
| Overall Study | Suspected serious adverse drug reaction | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Anagrelide Hydrochloride |
|---|---|
| Age, Continuous | 67.0 years STANDARD_DEVIATION 15.4 |
| Age, Customized <=60 years | 42 Participants |
| Age, Customized >60 years | 133 Participants |
| Region of Enrollment France | 175 Participants |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 81 / 175 |
| serious Total, serious adverse events | 8 / 175 |
Outcome results
Primary
Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy
Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy | Full response | 25.0 percentage of subjects |
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy | Partial response | 31.3 percentage of subjects |
Primary
Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) | Full response | 44.4 percentage of subjects |
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) | Partial response | 30.8 percentage of subjects |
Primary
Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) | Full response | 32.4 percentage of subjects |
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) | Partial response | 21.6 percentage of subjects |
Primary
Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation | Full response | 48.7 percentage of subjects |
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation | Partial response | 38.5 percentage of subjects |
Primary
Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
Full response is a platelet count of \<400x10\^9/L. Partial response is a platelet count between 400-600x10\^9/L or a platelet count reduction of 200x10\^9. Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation | Full response | 41.7 percentage of subjects |
| Anagrelide Hydrochloride | Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation | Partial response | 25.2 percentage of subjects |
Primary
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy | 81.3 percentage of subjects |
Primary
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) | 83.5 percentage of subjects |
Primary
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) | 89.2 percentage of subjects |
Primary
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation | 94.9 percentage of subjects |
Primary
Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Time frame: 6 months
Population: Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation | 81.7 percentage of subjects |
Secondary
Maximum Daily Dose of Anagrelide Hydrochloride
Time frame: 6 months
Population: Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anagrelide Hydrochloride | Maximum Daily Dose of Anagrelide Hydrochloride | 1.5 mg/day | Standard Deviation 0.6 |
Secondary
Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only
Time frame: 6 months
Population: Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | -1.0 mg/day | 1 participants |
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | +1.2 mg/day | 1 participants |
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | -0.5 mg/day | 7 participants |
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | -0.2 mg/day | 2 participants |
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | No change | 26 participants |
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | +0.2 mg/day | 1 participants |
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | +0.5 mg/day | 109 participants |
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | +1.0 mg/day | 12 participants |
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | Dose interruption | 9 participants |
| Anagrelide Hydrochloride | Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only | Discontinued therapy | 7 participants |
Secondary
Percentage of Subjects With Anagrelide Hydrochloride Starting Doses
Time frame: 6 months
Population: Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Percentage of Subjects With Anagrelide Hydrochloride Starting Doses | 1.5 mg/day | 5.1 percentage of subjects |
| Anagrelide Hydrochloride | Percentage of Subjects With Anagrelide Hydrochloride Starting Doses | 0.3 mg/day | 0.6 percentage of subjects |
| Anagrelide Hydrochloride | Percentage of Subjects With Anagrelide Hydrochloride Starting Doses | 0.5 mg/day | 41.1 percentage of subjects |
| Anagrelide Hydrochloride | Percentage of Subjects With Anagrelide Hydrochloride Starting Doses | 1.0 mg/day | 52.6 percentage of subjects |
| Anagrelide Hydrochloride | Percentage of Subjects With Anagrelide Hydrochloride Starting Doses | 1.3 mg/day | 0.6 percentage of subjects |
Secondary
Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Time frame: 6 months
Population: Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation | ADR | 44.3 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation | Serious ADR | 5.2 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation | ADR leading to stopping Xagrid | 16.5 percentage of subjects |
Secondary
Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Time frame: 6 months
Population: Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy | ADR | 37.5 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy | Serious ADR | 6.3 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy | ADR leading to stopping Xagrid | 12.5 percentage of subjects |
Secondary
Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Time frame: 6 months
Population: Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) | ADR | 39.1 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) | Serious ADR | 4.5 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC) | ADR leading to stopping Xagrid | 18.8 percentage of subjects |
Secondary
Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables: •Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC): •Consistent if: -The starting dose was \<=1 mg/day, AND -Any increase in dose was no more than 0.5mg/day, AND -Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND -The maximum dose did not exceed 10 mg/day at any stage. •Inconsistent: in all other cases
Time frame: 6 months
Population: Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) | ADR | 67.6 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) | Serious ADR | 5.4 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC) | ADR leading to stopping Xagrid | 5.4 percentage of subjects |
Secondary
Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables: •Withdrawal of previous cytoreductive therapy: -Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation -After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases
Time frame: 6 months
Population: Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation | ADR | 51.3 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation | Serious ADR | 2.6 percentage of subjects |
| Anagrelide Hydrochloride | Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation | ADR leading to stopping Xagrid | 15.4 percentage of subjects |