Essential Thrombocythemia (ET)
Conditions
Brief summary
The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.
Interventions
DRUGSPD422 (anagrelide hydrochloride)
Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.
Sponsors
Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have completed Study SPD422 308
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Platelet Count at Final Assessment | Baseline and final assessment (within 5 days of the last dose of investigational product) | Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). |
| Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment | Baseline and final assessment (within 5 days of the last dose of investigational product) | Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). |
| Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product) | Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who achieved platelet count \<600 x 10\^9 platelets per liter at each visit were reported. |
| Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial | Baseline and final assessment (within 5 days of the last dose of investigational product) | Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who achieved platelet count \<600 x 10\^9 platelets per liter during the post-marketing trial were reported. |
| Percentage of Participants Who Achieved Shift From Baseline in Platelet Count | Baseline and final assessment (within 5 days of the last dose of investigational product) | Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last nonmissing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who had platelet count \<600 x 10\^9 platelet per liter and greater than equal (\>=) 600 x 10\^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) \* 100. |
| Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial | Baseline and final assessment (within 5 days of the last dose of investigational product) | Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who had platelet count \<600 x 10\^9 platelet per liter and greater than equal (\>=) 600 x 10\^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) \* 100. |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. |
| Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial | From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. |
| Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result | From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis. |
| Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial | From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis. |
| Percentage of Participants With TEAEs and TESAEs Related to Vital Signs | From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight. |
| Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial | From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight. |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product | Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study. |
Countries
Japan
Participant flow
Recruitment details
The study was conducted in 15 centers in the Japan between 27 October 2010 and 01 May 2015.
Pre-assignment details
Overall 53 participants were enrolled in study SPD422-308 (NCT01214915), 42 of them completed the study. Of these 42 participants, 41 entered in to the current extension study SPD422-309 (NCT01467661) with 33 of 41 participants entered the post marketing trial and 32 participants completed the study (after marketing approval was granted).
Participants by arm
| Arm | Count |
|---|---|
| SPD422 (Anagrelide Hydrochloride) Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Not enrolled to SPD422-309 (NCT01467661) | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | SPD422 (Anagrelide Hydrochloride) |
|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 13.1 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 53 / 53 | 13 / 33 |
| serious Total, serious adverse events | 21 / 53 | 1 / 33 |
Outcome results
Primary
Change From Baseline in Platelet Count at Final Assessment
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit).
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Population: Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Change From Baseline in Platelet Count at Final Assessment | Baseline | 1021.6 10^9 platelets per liter (10^9/L) | Standard Deviation 433.14 |
| SPD422 (Anagrelide Hydrochloride) | Change From Baseline in Platelet Count at Final Assessment | Change at final assessment | -346.2 10^9 platelets per liter (10^9/L) | Standard Deviation 638.35 |
Primary
Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit).
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Population: Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment | Baseline | 1088.3 10^9 platelets per liter (10^9/L) | Standard Deviation 486.33 |
| SPD422 (Anagrelide Hydrochloride) | Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment | Change at final assessment | -647.9 10^9 platelets per liter (10^9/L) | Standard Deviation 514.89 |
Primary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Population: Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 11 participants |
Primary
Percentage of Participants Who Achieved Platelet Count Less Than (<) 600
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who achieved platelet count \<600 x 10\^9 platelets per liter at each visit were reported.
Time frame: Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product)
Population: Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number of participants analysed at specific time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Baseline (n = 53) | 11.3 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Week 1 (n = 53 ) | 17.0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 1 (n = 49) | 42.9 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 2 (n = 48) | 50.0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 3 (n = 46) | 54.3 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 4 (n = 45) | 60.0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 5 (n = 45) | 66.7 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 6 (n = 44) | 65.9 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 7 (n = 43) | 67.4 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 8 (n = 43) | 72.1 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 9 (n = 43) | 69.8 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 10 (n = 43) | 69.8 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 11 (n = 42) | 69.0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 12 (n = 42) | 69.0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 15 (n = 41) | 75.6 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 18 (n = 41) | 78.0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 21 (n = 40) | 77.5 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 24 (n = 38) | 78.9 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 27 (n = 38) | 81.6 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 30 (n = 37) | 75.7 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 33 (n = 36) | 72.2 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 36 (n = 36) | 83.3 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 39 (n = 33) | 81.8 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 42 (n = 26) | 73.1 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 45 (n = 16) | 68.8 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Month 48 (n = 11) | 81.8 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | Final assessment (n = 53) | 60.4 percentage of participants |
Primary
Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who achieved platelet count \<600 x 10\^9 platelets per liter during the post-marketing trial were reported.
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Population: Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial | Baseline (n = 33) | 12.1 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial | Final assessment(n = 31) | 80.6 percentage of participants |
Primary
Percentage of Participants Who Achieved Shift From Baseline in Platelet Count
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last nonmissing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who had platelet count \<600 x 10\^9 platelet per liter and greater than equal (\>=) 600 x 10\^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) \* 100.
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Population: Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number for participants evaluable at the specific category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Shift From Baseline in Platelet Count | FA: Platelet count <600 to <600 (n = 6) | 9.4 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Shift From Baseline in Platelet Count | FA: Platelet count <600 to >=600 (n = 6) | 1.9 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Shift From Baseline in Platelet Count | FA: Platelet count >=600 to <600 (n = 47) | 50.9 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Shift From Baseline in Platelet Count | FA: Platelet count >=600 to >=600 (n = 47) | 37.7 percentage of participants |
Primary
Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who had platelet count \<600 x 10\^9 platelet per liter and greater than equal (\>=) 600 x 10\^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) \* 100.
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
Population: Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number for participants evaluable at the specific category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial | FA: Platelet count <600 to <600 (n = 3) | 9.7 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial | FA: Platelet count <600 to >=600 (n = 3) | 0.0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial | FA: Platelet count >=600 to <600 (n = 28) | 71.0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial | FA: Platelet count >=600 to >=600 (n = 28) | 19.4 percentage of participants |
Primary
Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Population: Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial | Participants with TEAEs | 39.4 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial | Participants with TESAEs | 3.0 percentage of participants |
Primary
Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Population: Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result | Participants with TEAEs | 73.6 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result | Participants with TESAEs | 1.9 percentage of participants |
Primary
Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Population: Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial | Participants with TEAEs | 0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial | Participants with TESAEs | 0 percentage of participants |
Primary
Percentage of Participants With TEAEs and TESAEs Related to Vital Signs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Population: Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs Related to Vital Signs | Participants with TEAEs | 5.7 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs Related to Vital Signs | Participants with TESAEs | 0 percentage of participants |
Primary
Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Population: Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial | Participants with TEAEs | 3.0 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial | Participants with TESAEs | 0 percentage of participants |
Primary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
Time frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product
Population: Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Participants with TEAEs | 100 percentage of participants |
| SPD422 (Anagrelide Hydrochloride) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Participants with TESAEs | 39.6 percentage of participants |