Trial · NCT00567502
Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
NCT00567502, Completed, Shire; results first posted 2015-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments. Trials, record NCT00567502. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00567502
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
- NCT number
- NCT00567502
- Status
- Completed
- Enrollment
- 3,647 participants, actual
- Lead sponsor
- Shire
- Conditions
- Thrombocythemia, Essential
- First posted
- 2007-12-05
- Last updated
- 2021-06-09
- Results first posted
- 2015-11-17
- Limitations and caveats
- Results for other adverse events (excluding SAEs) was reported under OM 1 due to limitation in basic result's format, as SAEs and non-SAEs were not planned to be reported separately.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | Up to 5 years | Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE. |
| Primary | Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events | Up to 5 years | SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group. |
| Secondary | Event Rate of Thrombohaemorrhagic Events | Up to 5 years | Event Rate of Thrombohaemorrhagic Events was calculated by dividing number of participants with events by total patient-year exposure. The reporting unit is per 100 participant-years of treatment exposure. Thrombohaemorrhagic Events is a composite endpoint of the PDEs myocardial infarction, angina, stroke, transient ischaemic attack, venous thromboembolic events, intermittent claudication/digital ischaemia, and major haemorrhagic events. |
| Secondary | Platelet Count | Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60 | |
| Secondary | Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy | Up to 5 years | Total duration for each participant = sum of \[stop date - start date + 1\] across all periods of time where the specific treatment was taken during the study, where start date = registration/consent date for treatments started before registration/consent date and/or stop date withdrawal/final date for treatments ongoing at the time of withdrawal/end of study. Where a participant has multiple records of the same therapy on the same day, the therapy is counted once for that day. |
| Secondary | Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy | Up to 5 years | Since the study is observational nature, interpreting the table is difficult due to inconsistencies in reporting the units of the dose. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | Up to 5 years | First Treatment Safety Population included participants who received cytoreductive therapy at registration. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment. | percentage of participants | NUMBER |
| SECONDARY | Event Rate of Thrombohaemorrhagic Events | Up to 5 years | Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study. | participants/100 participant-years | NUMBER |
| SECONDARY | Platelet Count | Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60 | Overall Treatment Safety population, Here n = participants evaluable at specified time-points. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study. | 10^9 per Liter (10^9/L) | MEAN |
| SECONDARY | Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy | Up to 5 years | Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study. | days | MEAN |
| SECONDARY | Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy | Up to 5 years | Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study. | milligram (mg) | MEAN |
| PRIMARY | Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events | Up to 5 years | Overall treatment safety population. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment. Participants who had exposed to XAGRID (alone or in combination with other) was counted in Xagrid arm and those who had received other ET therapy in the Other (Cytoreductives). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group149
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | XAGRID Only | Myocardial infarction | 1.0 | percentage of participants | |
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | XAGRID+Other (Cytoreductives) | Myocardial infarction | 0.0 | percentage of participants | |
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | Other (Cytoreductives) | Myocardial infarction | 1.5 | percentage of participants | |
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | XAGRID Only | Angina | 0.7 | percentage of participants | |
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | XAGRID+Other (Cytoreductives) | Angina | 0.0 | percentage of participants | |
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | Other (Cytoreductives) | Angina | 0.7 | percentage of participants | |
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | XAGRID Only | Congestive heart failure | 1.2 | percentage of participants | |
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | XAGRID+Other (Cytoreductives) | Congestive heart failure | 1.4 | percentage of participants | |
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | Other (Cytoreductives) | Congestive heart failure | 1.2 | percentage of participants | |
| Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies | XAGRID Only | Cardiomyopathy | 0.5 | percentage of participants |
1 to 10 of 149Source ClinicalTrials.gov
See all 149 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | XAGRID Only | 804 | |
| Overall Study | STARTED | XAGRID+Other (Cytoreductives) | 141 | |
| Overall Study | STARTED | Other (Cytoreductives) | 2,666 | |
| Overall Study | STARTED | No Essential Thrombocythemia (ET) Therapy | 110 | |
| Overall Study | Initiated Treatment | XAGRID Only | 804 | |
| Overall Study | Initiated Treatment | XAGRID+Other (Cytoreductives) | 141 | |
| Overall Study | Initiated Treatment | Other (Cytoreductives) | 2,666 | |
| Overall Study | Initiated Treatment | No Essential Thrombocythemia (ET) Therapy | 38 | |
| Overall Study | COMPLETED | XAGRID Only | 563 | |
| Overall Study | COMPLETED | XAGRID+Other (Cytoreductives) | 108 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events132
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | XAGRID | 1 | 1,300 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Other (Cytoreductives) | 9 | 3,069 | 9 |
| serious | Leukopenia | Blood and lymphatic system disorders | XAGRID | 0 | 1,300 | 0 |
| serious | Leukopenia | Blood and lymphatic system disorders | Other (Cytoreductives) | 1 | 3,069 | 1 |
| serious | Neutropenia | Blood and lymphatic system disorders | XAGRID | 0 | 1,300 | 0 |
| serious | Neutropenia | Blood and lymphatic system disorders | Other (Cytoreductives) | 1 | 3,069 | 1 |
| serious | Pancytopenia | Blood and lymphatic system disorders | XAGRID | 0 | 1,300 | 0 |
| serious | Pancytopenia | Blood and lymphatic system disorders | Other (Cytoreductives) | 2 | 3,069 | 2 |
| serious | Splenic infarction | Blood and lymphatic system disorders | XAGRID | 1 | 1,300 | 1 |
| serious | Splenic infarction | Blood and lymphatic system disorders | Other (Cytoreductives) | 1 | 3,069 | 1 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XAGRID | ||
| Total, all-cause mortality | Other (Cytoreductives) | ||
| Total, other adverse events | XAGRID | 0 | 0 |
| Total, other adverse events | Other (Cytoreductives) | 0 | 0 |
| Total, serious adverse events | XAGRID | 37 | 1,300 |
| Total, serious adverse events | Other (Cytoreductives) | 70 | 3,069 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| XAGRID vs Other (Cytoreductives): Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events | Trial comparisons |
| XAGRID vs Other (Cytoreductives): serious adverse events | 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/NCT00567502
GET https://conductscience.org/api/trials/v1/NCT00567502/results?page=2