Trial · NCT02516579
European Sickle Cell Disease Cohort - Hydroxyurea
NCT02516579, Completed, Theravia; results first posted 2020-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. European Sickle Cell Disease Cohort - Hydroxyurea. Trials, record NCT02516579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02516579
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- European Sickle Cell Disease Cohort - Hydroxyurea
- NCT number
- NCT02516579
- Status
- Completed
- Enrollment
- 1,906 participants, actual
- Lead sponsor
- Theravia
- Conditions
- Sickle Cell Disease
- Interventions
- Siklos
- First posted
- 2015-08-06
- Last updated
- 2020-03-19
- Results first posted
- 2020-03-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | % of Patient-years With Malignancies | During the follow-up of participant, up to 10 years | |
| Primary | % of Patient-years With Skin Ulcerations | During the follow-up of participant, up to 10 years | Patients with at least one skin ulceration |
| Primary | % of Patient-years With Myelosuppressions | During the follow-up of participant, up to 10 years | Patients with at least one myelosuppression |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | % of Patient-years With Malignancies | During the follow-up of participant, up to 10 years | Patients with follow-up visit | % patient-years | NUMBER |
| PRIMARY | % of Patient-years With Skin Ulcerations | During the follow-up of participant, up to 10 years | % patient-years | NUMBER | |
| PRIMARY | % of Patient-years With Myelosuppressions | During the follow-up of participant, up to 10 years | % patient-years | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| % of Patient-years With Malignancies | Patients With Sickle Cell Disease Treated With Siklos® | 0.001 | % patient-years | ||
| % of Patient-years With Skin Ulcerations | Patients With Sickle Cell Disease Treated With Siklos® | 1.13 | % patient-years | ||
| % of Patient-years With Myelosuppressions | Patients With Sickle Cell Disease Treated With Siklos® | 5.99 | % patient-years |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients With Sickle Cell Disease Treated With Siklos® | 1,906 | |
| Overall Study | COMPLETED | Patients With Sickle Cell Disease Treated With Siklos® | 1,906 | |
| Overall Study | NOT COMPLETED | Patients With Sickle Cell Disease Treated With Siklos® | 0 |
Source ClinicalTrials.gov
Adverse events7
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 | infections and infestations | Infections and infestations | Patients With Sickle Cell Disease Treated With Siklos® | 645 | 1,903 | |
| other | General disorders and administration site conditions | General disorders | Patients With Sickle Cell Disease Treated With Siklos® | 386 | 1,903 | |
| other | Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Patients With Sickle Cell Disease Treated With Siklos® | 370 | 1,903 | |
| serious | infections and infestations | Infections and infestations | Patients With Sickle Cell Disease Treated With Siklos® | 346 | 1,903 | |
| serious | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Patients With Sickle Cell Disease Treated With Siklos® | 155 | 1,903 | |
| serious | respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Patients With Sickle Cell Disease Treated With Siklos® | 151 | 1,903 | |
| serious | general disorders and administration site conditions | General disorders | Patients With Sickle Cell Disease Treated With Siklos® | 97 | 1,903 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients With Sickle Cell Disease Treated With Siklos® | 33 | 1,903 |
| Total, other adverse events | Patients With Sickle Cell Disease Treated With Siklos® | 1,308 | 1,903 |
| Total, serious adverse events | Patients With Sickle Cell Disease Treated With Siklos® | 705 | 1,903 |
Source ClinicalTrials.gov
Papers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02516579
GET https://conductscience.org/api/trials/v1/NCT02516579/registered