N/A
N=1,906
European Sickle Cell Disease Cohort - Hydroxyurea
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT02516579 ↗Enrolled (actual)
1,906
Serious AEs
37.1%
Results posted
Mar 2020
Primary outcome: Primary: % of Patient-years With Malignancies — 0.001 % patient-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Siklos (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Theravia
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % of Patient-years With Malignancies |
0.001 | — |
| PRIMARY % of Patient-years With Skin Ulcerations |
1.13 | — |
| PRIMARY % of Patient-years With Myelosuppressions |
5.99 | — |
Summary
In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.
Eligibility Criteria
Inclusion Criteria
- Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults)
- With symptomatic sickle cell syndrome
- Treated with Siklos®
- Having been informed of the study by the initiating physician and consenting to participate to the cohort.
Data sourced from ClinicalTrials.gov (NCT02516579). 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.