French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01192347
• Collaborator: (none)
• Enrollment: 177
• Locations: 46
• Actual Duration (Months): 27.3
• Patients Per Site: 3.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Thrombocythemia

Study Design

• Study Type: Observational
• Actual Enrollment: 177 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Phase 4, 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
• Actual Study Start Date: Sep 13, 2010
• Actual Primary Completion Date: Dec 21, 2012
• Actual Study Completion Date: Dec 21, 2012

Outcome Measures

Primary Outcome Measures

1. 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was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up -Not Withdrawn: in all other cases

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

Secondary Outcome Measures

1. Percentage of Subjects With Anagrelide Hydrochloride Starting Doses [6 months]

2. Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only [6 months]

3. 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

4. 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

5. 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

6. 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

7. 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

8. Maximum Daily Dose of Anagrelide Hydrochloride [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GH Pitie Salpetriere	Paris	Cedex 13	France	75651
2	CH DU Pays D Aix	Aix En Provence	Cedex 1	France	13616
3	Hopital Dupuytren	Limoges	Cedex 1	France	87042
4	Hopital Emile Muller	Mulhouse	Cedex 1	France	68070
5	Hopital Hotel Dieu Et Hme	Nantes	Cedex 1	France	44093
6	Hopital Tenon	Paris	Cedex 20	France	75970
7	Nouvelles Cliniques Nantaises	Nantes	Cedex 2	France	44277
8	Hopital Hautepierre	Strasbourg	Cedex 2	France	67098
9	Hopital De L Archet	Nice	Cedex 3	France	6202
10	Clinique Du Parc	Caen	Cedex 4	France	14052
11	Hotel Dieu	Angers	Cedex 9	France	49933
12	CH Departemental Des Oudairies	La Roche Sur Yon	Cedex 9	France	85925
13	Hopital Pontchaillou	Rennes	Cedex 9	France	35033
14	Hia Sainte Anne	Toulon	Cedex 9	France	83041
15	Ch D Arras	Arras	Cedex	France	62022
16	Hopital Robert Ballanger	Aulnay Sous Bois	Cedex	France	93602
17	CH De Blois	Blois	Cedex	France	41016
18	Ch De Fleyriat	Bourg En Bresse	Cedex	France	1012
19	CME	Brest	Cedex	France	29609
20	Hopital Augustin Morvan	Brest	Cedex	France	29609
21	Ch De Brive La Gaillarde	Brive La Gaillarde	Cedex	France	19312
22	Hopital Henri Mondor	Creteil	Cedex	France
23	CH De Bicetre	Le Kremlin Bicetre	Cedex	France	94275
24	CHRU Lille - Hopital Huriez	Lille	Cedex	France	59037
25	Hopital Saint Philibert	Lomme	Cedex	France	59462
26	Hopital Edouard Herriot	Lyon	Cedex	France	69437
27	Institut J Paoli Calmettes	Marseille	Cedex	France	13273
28	Hopital N D Bon Secours	Metz	Cedex	France	57038
29	Clinique Pont de Chaume	Montauban	Cedex	France	82017
30	Hopital Saint Antoine	Paris	Cedex	France	41016
31	GH Pitie Salpetriere	Paris	Cedex	France	75651
32	Hopital Saint Jean	Perpignan	Cedex	France	66046
33	Hopital De Haut Leveque	Pessac	Cedex	France	33604
34	CHI Poissy Saint German en Laye	Poissy	Cedex	France	78303
35	Chi De Cornouaille	Quimper	Cedex	France	29107
36	Hopital de La Maison Blanche	Reims	Cedex	France	51092
37	Institut de Cancerologie de la Loire	Saint Priest En Jarez	Cedex	France	42271
38	Hopital Font Pre	Toulon	Cedex	France	83056
39	Hopitaux de Brabois	Vandoeuvre Les Nancy	Cedex	France	54511
40	Ch De Vendome	Vendome	Cedex	France	41106
41	Polyclinique Bordeaux Nord Aquitaine	Bordeaux		France	33300
42	Hopital Robert Boulin	Libourne		France	33505
43	CHU Nord - Chemin Des Bourrely	Marseille		France	13015
44	CHRA	Metz Tessy		France	74370
45	Cabinet D'Hematologie	Perpignan		France	66000
46	Centre De Radiotherapie	Strasbourg		France	67000

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01192347
• Other Study ID Numbers: SPD422-702
• First Posted: Sep 1, 2010
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Thrombocytosis; Thrombocythemia, Essential

Study Results

Participant Flow

Pre-assignment Detail	177 subjects were enrolled, but 2 never received Anagrelide Hydrochloride (Xagrid) and were excluded from the trial (n = 175).

Arm/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Period Title: Overall Study
STARTED	175
COMPLETED	163
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Participants	175
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.0 (15.4)
Age, Customized (Count of Participants)
<=60 years	42 24%
>60 years	133 76%
Sex: Female, Male (Count of Participants)
Female	108 61.7%
Male	67 38.3%
Region of Enrollment (Count of Participants)
France	175 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	115
Number (95% Confidence Interval) [percentage of subjects]	81.7

2. Primary Outcome

Title	Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	39
Number (95% Confidence Interval) [percentage of subjects]	94.9

3. Secondary Outcome

Title	Percentage of Subjects With Anagrelide Hydrochloride Starting Doses
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	175
0.3 mg/day	0.6
0.5 mg/day	41.1
1.0 mg/day	52.6
1.3 mg/day	0.6
1.5 mg/day	5.1

4. Secondary Outcome

Title	Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	175
-1.0 mg/day	1 0.6%
-0.5 mg/day	7 4%
-0.2 mg/day	2 1.1%
No change	26 14.9%
+0.2 mg/day	1 0.6%
+0.5 mg/day	109 62.3%
+1.0 mg/day	12 6.9%
+1.2 mg/day	1 0.6%
Dose interruption	9 5.1%
Discontinued therapy	7 4%

5. Primary Outcome

Title	Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	16
Number (95% Confidence Interval) [percentage of subjects]	81.3

6. Primary Outcome

Title	Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	133
Number (95% Confidence Interval) [percentage of subjects]	83.5

7. Primary Outcome

Title	Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	37
Number (95% Confidence Interval) [percentage of subjects]	89.2

8. Primary Outcome

Title	Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	115
Full response	41.7
Partial response	25.2

9. Primary Outcome

Title	Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	39
Full response	48.7
Partial response	38.5

10. Primary Outcome

Title	Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	16
Full response	25.0
Partial response	31.3

11. Primary Outcome

Title	Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	133
Full response	44.4
Partial response	30.8

12. Primary Outcome

Title	Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	37
Full response	32.4
Partial response	21.6

13. Secondary Outcome

Title	Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	115
ADR	44.3
Serious ADR	5.2
ADR leading to stopping Xagrid	16.5

14. Secondary Outcome

Title	Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	39
ADR	51.3
Serious ADR	2.6
ADR leading to stopping Xagrid	15.4

15. Secondary Outcome

Title	Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	16
ADR	37.5
Serious ADR	6.3
ADR leading to stopping Xagrid	12.5

16. Secondary Outcome

Title	Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	133
ADR	39.1
Serious ADR	4.5
ADR leading to stopping Xagrid	18.8

17. Secondary Outcome

Title	Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	37
ADR	67.6
Serious ADR	5.4
ADR leading to stopping Xagrid	5.4

18. Secondary Outcome

Title	Maximum Daily Dose of Anagrelide Hydrochloride
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Measure Participants	175
Mean (Standard Deviation) [mg/day]	1.5 (0.6)

Adverse Events

Arm/Group Title	Anagrelide Hydrochloride
Arm/Group Description	The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
All Cause Mortality
	Anagrelide Hydrochloride
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Anagrelide Hydrochloride
	Affected / at Risk (%)	# Events
Total	8/175 (4.6%)
Blood and lymphatic system disorders
Anemia	1/175 (0.6%)	1
Cardiac disorders
Angina pectoris	1/175 (0.6%)	1
Cardiac failure	1/175 (0.6%)	1
Palpitations	1/175 (0.6%)	1
Nervous system disorders
Cerebrovascular accident	1/175 (0.6%)	2
Headache	1/175 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension	1/175 (0.6%)	1
Vascular disorders
Hypertensive crisis	2/175 (1.1%)	2
Other (Not Including Serious) Adverse Events
	Anagrelide Hydrochloride
	Affected / at Risk (%)	# Events
Total	81/175 (46.3%)
Blood and lymphatic system disorders
Anemia	4/175 (2.3%)	5
Cardiac disorders
Edema peripheral	4/175 (2.3%)	4
Palpitations	22/175 (12.6%)	24
Tachycardia	5/175 (2.9%)	5
Ear and labyrinth disorders
Tinnitis	4/175 (2.3%)	5
Gastrointestinal disorders
Abdominal pain	5/175 (2.9%)	5
Diarrhea	10/175 (5.7%)	10
Nausea	5/175 (2.9%)	5
General disorders
Asthenia	10/175 (5.7%)	10
Nervous system disorders
Headache	18/175 (10.3%)	20

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.