N/A
N=3,721
Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
Thrombocythemia, Essential
Bottom Line
View on ClinicalTrials.gov: NCT00567502 ↗Enrolled (actual)
3,721
Serious AEs
2.5%
Results posted
Nov 2015
Primary outcome: Primary: Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies — 1.0; 0.0; 1.5; 0.7 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies |
1.0; 0.0; 1.5; 0.7; 0.0; 0.7 | — |
| PRIMARY Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events |
37; 70 | — |
| SECONDARY Event Rate of Thrombohaemorrhagic Events |
2.75; 2.86; 2.60; 4.91 | — |
| SECONDARY Platelet Count |
486.90; 542.77; 471.29; 837.23; 1093.73; 521.44 | — |
| SECONDARY Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy |
1213.7; 1382.3; 933.3; 744.0; 510.2; 992.8 | — |
| SECONDARY Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy |
29096.2; 957751.4; 3592.2; 5103.1; 7749.6; 28612.7 | — |
Summary
This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions (SSARs).
Eligibility Criteria
Inclusion Criteria
- High risk ET patients
- Subjects who can give written informed consent.
- Subjects taking cytoreductive therapy
Exclusion Criteria
- Contraindications listed by the product being used.
- Patient cannot be participating in another clinical trial.
Data sourced from ClinicalTrials.gov (NCT00567502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.