Ciclosporin in the management of ENL reactions
Lambert, S
(2015).
Ciclosporin in the management of ENL reactions.
[Dataset].
London School of Hygiene & Tropical Medicine, London, United Kingdom.
10.17037/DATA.17.
(2015).
Ciclosporin in the management of ENL reactions.
[Dataset].
London School of Hygiene & Tropical Medicine, London, United Kingdom.
10.17037/DATA.17.
Data produced as part of a clinical trial to compare the efficacy and safety of Ciclosporin and Prednisolone in the Treatment of Erythema Nodosum Leprosum (ENL). The trial was conducted with two randomised, double blind, controlled groups in Ethiopia. The first group had acute first time occurrence of ENL and the second group had recurrent ENL. Both groups were randomized to one of two study arms: the ciclosporin treatment arm or the prednisolone treatment arm. Patients were followed over a 32 week period, where they were assessed for changes in clinical signs and adverse events.
Keywords
Leprosy, Leprosy reaction, Erythema Nodosum Leprosum, Adverse events, Ciclosporin, Prednisolone| Item Type | Dataset |
|---|---|
| Description of data capture | Data from each assessment was recorded on standardised Patient Record Forms (PRF) and kept in a set of case notes separate from other hospital record. Data was verified and entered into Case Record Forms (CRF) by the study physicians. Double data entry into a Microsoft Access 2007 database was performed by Saba Lambera and a data manager at ALERT/AHRI. Double entry was then verified using Epi-Info 3.5.4. The initial rate of errors detected by double entry was just under 10%. Errors in the data were verified and corrected in Ethiopia. Errors were traced back to the CRFs and correct. Epi-info was re-run and procedures repeated until two identical and correct databases were obtained. Finally, the MS Access data tables were transferred to SPSS v20 for analysis. |
| Capture method | Measurements and tests |
| Collection Period |
From To 12 August 2011 10 May 2012 |
| Date | 1 October 2015 |
| Geographical area covered (offline during plugin upgrade) |
North Latitude East Longitude South Latitude West Longitude 9.06403 38.8541 8.90533 38.6321 |
| Language(s) of written materials | English |
| Creator(s) |
Lambert, S
|
| Associated roles | Nicholls, P (Data Manager), Yamuah, L, Lockwood, D, Tsegaye, D (Project Leader) and Nigusse, S |
| LSHTM Faculty/Department | Faculty of Public Health and Policy > Dept of Public Health, Environments and Society |
| Participating Institutions | London School of Hygiene & Tropical Medicine, London, United Kingdom |
| Funders |
Project Funder Grant Number Funder URI Assessing Ciclosporin in the Treatment of Leprosy Reactions: Evidence from a Randomized Controlled Trial and Other Studies ITCRBY24 UNSPECIFIED |
| Date Deposited | 11 Nov 2015 14:04 |
| Last Modified | 27 Apr 2022 18:19 |
| Publisher | London School of Hygiene & Tropical Medicine |
UserGuide.pdf
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subject - Documentation
- Creative Commons: Attribution
- Available under Creative Commons: Attribution 3.0
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info - User guide on ELN A and B dataset
picture_as_pdf - application/pdf
- folder_info
- 421kB
Ciclospori_Reaction_Studies_SOP.pdf
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subject - Documentation
- Creative Commons: Attribution-Noncommercial-Share Alike
- Available under Creative Commons: Attribution-Noncommercial-Share Alike 3.0
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info - Standard Operating Procedure/Protocol for study
picture_as_pdf - application/pdf
- folder_info
- 1MB
ENLA_dataset.zip
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subject - Data
-
lock - Restricted to Request access for all
- Data Sharing Agreement
- Available under Data Sharing Agreement
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info - Anonymised dataset of Erythema Nodosum Leprosum analysis
folder_zip - application/zip
- folder_info
- 22B
ENLB_dataset.zip
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subject - Data
-
lock - Restricted to Request access for all
- Data Sharing Agreement
- Available under Data Sharing Agreement
-
info - Anonymised dataset of Erythema Nodosum Leprosum analysis
folder_zip - application/zip
- folder_info
- 22B
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