Trial · NCT01467661
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
NCT01467661, Phase 3, Completed, Shire; results first posted 2016-06-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia. Trials, record NCT01467661. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01467661
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
- NCT number
- NCT01467661
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 41 participants, actual
- Lead sponsor
- Shire
- Conditions
- Essential Thrombocythemia (ET)
- Interventions
- SPD422 (anagrelide hydrochloride)
- First posted
- 2011-11-09
- Last updated
- 2021-06-09
- Results first posted
- 2016-06-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). |
| Primary | 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). |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Platelet Count at Final Assessment | Baseline and final assessment (within 5 days of the last dose of investigational product) | Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). | 10^9 platelets per liter (10^9/L) | MEAN |
| PRIMARY | 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) | 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. | 10^9 platelets per liter (10^9/L) | MEAN |
| PRIMARY | 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) | 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. | percentage of participants | NUMBER |
| PRIMARY | 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) | 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. | percentage of participants | NUMBER |
| PRIMARY | 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) | 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. | percentage of participants | NUMBER |
| PRIMARY | 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) | 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. | percentage of participants | NUMBER |
| PRIMARY | 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 | Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). | percentage of participants | NUMBER |
| PRIMARY | 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 | 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). | percentage of participants | NUMBER |
| PRIMARY | 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 | Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). | percentage of participants | NUMBER |
| PRIMARY | 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 | 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). | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Platelet Count at Final Assessment | SPD422 (Anagrelide Hydrochloride) | Baseline | 1021.6 | Standard Deviation 433.14 | 10^9 platelets per liter (10^9/L) |
| Change From Baseline in Platelet Count at Final Assessment | SPD422 (Anagrelide Hydrochloride) | Change at final assessment | -346.2 | Standard Deviation 638.35 | 10^9 platelets per liter (10^9/L) |
| Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment | SPD422 (Anagrelide Hydrochloride) | Baseline | 1088.3 | Standard Deviation 486.33 | 10^9 platelets per liter (10^9/L) |
| Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment | SPD422 (Anagrelide Hydrochloride) | Change at final assessment | -647.9 | Standard Deviation 514.89 | 10^9 platelets per liter (10^9/L) |
| Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | SPD422 (Anagrelide Hydrochloride) | Baseline (n = 53) | 11.3 | percentage of participants | |
| Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | SPD422 (Anagrelide Hydrochloride) | Week 1 (n = 53 ) | 17.0 | percentage of participants | |
| Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | SPD422 (Anagrelide Hydrochloride) | Month 1 (n = 49) | 42.9 | percentage of participants | |
| Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | SPD422 (Anagrelide Hydrochloride) | Month 2 (n = 48) | 50.0 | percentage of participants | |
| Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | SPD422 (Anagrelide Hydrochloride) | Month 3 (n = 46) | 54.3 | percentage of participants | |
| Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 | SPD422 (Anagrelide Hydrochloride) | Month 4 (n = 45) | 60.0 | percentage of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD422 (Anagrelide Hydrochloride) | 53 | |
| Overall Study | Completed SPD422-308 (NCT01214915) | SPD422 (Anagrelide Hydrochloride) | 42 | |
| Overall Study | Started SPD422-309 (NCT01467661) | SPD422 (Anagrelide Hydrochloride) | 41 | |
| Overall Study | Started Post Marketing Trial | SPD422 (Anagrelide Hydrochloride) | 33 | |
| Overall Study | COMPLETED | SPD422 (Anagrelide Hydrochloride) | 32 | |
| Overall Study | NOT COMPLETED | SPD422 (Anagrelide Hydrochloride) | 21 |
Source ClinicalTrials.gov
Adverse events676
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | SPD422: Safety Analysis Set | 29 | 53 | 32 |
| other | ANAEMIA | Blood and lymphatic system disorders | SPD422: Post-marketing Trial Safety Analysis Set | 0 | 33 | 0 |
| other | EOSINOPHILIA | Blood and lymphatic system disorders | SPD422: Safety Analysis Set | 4 | 53 | 6 |
| other | EOSINOPHILIA | Blood and lymphatic system disorders | SPD422: Post-marketing Trial Safety Analysis Set | 0 | 33 | 0 |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | SPD422: Safety Analysis Set | 6 | 53 | 6 |
| other | IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | SPD422: Post-marketing Trial Safety Analysis Set | 0 | 33 | 0 |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | SPD422: Safety Analysis Set | 1 | 53 | 4 |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | SPD422: Post-marketing Trial Safety Analysis Set | 0 | 33 | 0 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | SPD422: Safety Analysis Set | 2 | 53 | 2 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | SPD422: Post-marketing Trial Safety Analysis Set | 0 | 33 | 0 |
1 to 10 of 676Source ClinicalTrials.gov
See all 676 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD422: Safety Analysis Set | ||
| Total, all-cause mortality | SPD422: Post-marketing Trial Safety Analysis Set | ||
| Total, other adverse events | SPD422: Safety Analysis Set | 53 | 53 |
| Total, other adverse events | SPD422: Post-marketing Trial Safety Analysis Set | 13 | 33 |
| Total, serious adverse events | SPD422: Safety Analysis Set | 21 | 53 |
| Total, serious adverse events | SPD422: Post-marketing Trial Safety Analysis Set | 1 | 33 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30121892 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| SPD422: Safety Analysis Set vs SPD422: Post-marketing Trial Safety Analysis Set: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01467661
GET https://conductscience.org/api/trials/v1/NCT01467661/results?page=2