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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.
Akita University Hospital
Akita, Akita, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Kom
Honkomagome 3-18-22, Bunkyo-ku, Japan
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)
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)
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)
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.
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Nippon Medical School Hospital
Sendagi 1-1-5, Bunkyo-ku, Japan
Chiba University Hospital
Chuo-ku Inohana 1-8-1, Chiba-shi, Japan
Hokkaido University Hospital
Sapporo, Hokkaidō Prefecture, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
Gunma University Hospital
Showa-machi 3-39-15, Maebashi-shi, Japan
NHO Tokyo Medical Center
Higashigaoka 2-5-1, Meguro-ku, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan
...and 6 more locations
Time frame: Baseline and final assessment (within 5 days of the last dose of investigational product)
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)
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)
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
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
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
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
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
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
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