European Sickle Cell Disease Cohort - Hydroxyurea (ESCORT-HU)
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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.
Occurence of adverse events and serious adverse events, specifically: - Frequency of maligancies - Frequency of skin ulceration (broken out by severity) - Frequency of myelosuppression requiring temporary or permanent discontinuation of Siklos [ Time Frame: up to 1 year follow-up ]
Secondary Outcome Measures :
Effects of Siklos on growth development: specific examinations (scintigraphy, radiography,...) if the difference with the normal growth is upper than 2 standard deviations [ Time Frame: up to 1 year follow-up ]
Outcome of pregnancies: rates of miscarriage, stillbirths, APGAR score at birth, congenital malformations [ Time Frame: up to 1 year follow-up ]
Any occurrence of an unforeseen safety pattern [ Time Frame: up to 1 year follow-up ]
Other Outcome Measures:
Overall mortality and survival rates [ Time Frame: up to 1 year follow-up ]
Frequency of vaso-occlusive complications (painful crises, acute chest syndrome, stroke, acute splenic sequestration and infections) [ Time Frame: up to 1 year follow-up ]
Hospitalisation due to SCD events [ Time Frame: up to 1 year follow-up ]
Frequency of blood transfusions [ Time Frame: up to 1 year follow-up ]
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Layout table for eligibility information
Ages Eligible for Study:
2 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patient with sickle-cell disease
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.