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Trial record 3 of 231 for:    "essential thrombocythemia"

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

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ClinicalTrials.gov Identifier: NCT01192347
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : September 25, 2013
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Essential Thrombocythemia
Enrollment 177
Recruitment Details  
Pre-assignment Details 177 subjects were enrolled, but 2 never received Anagrelide Hydrochloride (Xagrid) and were excluded from the trial (n = 175).
Arm/Group Title Anagrelide Hydrochloride
Hide 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
Reason Not Completed
Death             3
Lost to Follow-up             3
Withdrawal by Subject             1
Adverse Event             1
Suspected serious adverse drug reaction             1
Patient seen in different hospital             1
Patient not visiting hospital regularly             1
Patient did not show up for visits             1
Arm/Group Title Anagrelide Hydrochloride
Hide Arm/Group Description The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Baseline Participants 175
Hide Baseline Analysis Population Description
Safety Set was used for Baseline measures. Safety Set comprised all patients who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment. Two patients did not receive Anagrelide Hydrochloride, therefore n = 175 for the Safety Set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants
67.0  (15.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants
<=60 years 42
>60 years 133
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants
Female
108
  61.7%
Male
67
  38.3%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 175 participants
177
[1]
Measure Description: All enrolled subjects
1.Primary Outcome
Title Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 115
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
81.7
(73.5 to 88.3)
2.Primary Outcome
Title Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
94.9
(82.7 to 99.4)
3.Primary Outcome
Title Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
81.3
(54.4 to 96.0)
4.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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 133
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
83.5
(76.0 to 89.3)
5.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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
89.2
(74.6 to 97.0)
6.Primary Outcome
Title Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 115
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Full response
41.7
(32.6 to 51.3)
Partial response
25.2
(17.6 to 34.2)
7.Primary Outcome
Title Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Full response
48.7
(32.4 to 65.2)
Partial response
38.5
(23.4 to 55.4)
8.Primary Outcome
Title Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Full response
25.0
(7.3 to 52.4)
Partial response
31.3
(11.0 to 58.7)
9.Primary Outcome
Title Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 133
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Full response
44.4
(35.8 to 53.2)
Partial response
30.8
(23.1 to 39.4)
10.Primary Outcome
Title Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Full response
32.4
(18.0 to 49.8)
Partial response
21.6
(9.8 to 38.2)
11.Secondary Outcome
Title Percentage of Subjects With Anagrelide Hydrochloride Starting Doses
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 175
Measure Type: Number
Unit of Measure: percentage of subjects
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
12.Secondary Outcome
Title Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 175
Measure Type: Number
Unit of Measure: participants
-1.0 mg/day 1
-0.5 mg/day 7
-0.2 mg/day 2
No change 26
+0.2 mg/day 1
+0.5 mg/day 109
+1.0 mg/day 12
+1.2 mg/day 1
Dose interruption 9
Discontinued therapy 7
13.Secondary Outcome
Title Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 115
Measure Type: Number
Unit of Measure: percentage of subjects
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: percentage of subjects
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of subjects
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: percentage of subjects
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 37
Measure Type: Number
Unit of Measure: percentage of subjects
ADR 67.6
Serious ADR 5.4
ADR leading to stopping Xagrid 5.4
18.Secondary Outcome
Title Maximum Daily Dose of Anagrelide Hydrochloride
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
Overall Number of Participants Analyzed 175
Mean (Standard Deviation)
Unit of Measure: mg/day
1.5  (0.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anagrelide Hydrochloride
Hide 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Anagrelide Hydrochloride
Affected / at Risk (%) # Events
Total   8/175 (4.57%)    
Blood and lymphatic system disorders   
Anemia  1/175 (0.57%)  1
Cardiac disorders   
Angina pectoris  1/175 (0.57%)  1
Cardiac failure  1/175 (0.57%)  1
Palpitations  1/175 (0.57%)  1
Nervous system disorders   
Cerebrovascular accident  1/175 (0.57%)  2
Headache  1/175 (0.57%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary arterial hypertension  1/175 (0.57%)  1
Vascular disorders   
Hypertensive crisis  2/175 (1.14%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Anagrelide Hydrochloride
Affected / at Risk (%) # Events
Total   81/175 (46.29%)    
Blood and lymphatic system disorders   
Anemia  4/175 (2.29%)  5
Cardiac disorders   
Edema peripheral  4/175 (2.29%)  4
Palpitations  22/175 (12.57%)  24
Tachycardia  5/175 (2.86%)  5
Ear and labyrinth disorders   
Tinnitis  4/175 (2.29%)  5
Gastrointestinal disorders   
Abdominal pain  5/175 (2.86%)  5
Diarrhea  10/175 (5.71%)  10
Nausea  5/175 (2.86%)  5
General disorders   
Asthenia  10/175 (5.71%)  10
Nervous system disorders   
Headache  18/175 (10.29%)  20
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Physician
Organization: Shire Development LLC
Phone: +1 866 842 5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01192347     History of Changes
Other Study ID Numbers: SPD422-702
First Submitted: August 26, 2010
First Posted: September 1, 2010
Results First Submitted: July 24, 2013
Results First Posted: September 25, 2013
Last Update Posted: March 14, 2014