Dataset for the Methotrexate and Prednisolone Study (MaPs) in Erythema Nodosum Leprosum: a multicentre randomised controlled trial – Data Codebook

Persistent identifier

10.17037/DATA.00005297

Description

This dataset contains individual-level participant data collected as part of the Methotrexate and Prednisolone Study (MaPs) in Erythema Nodosum Leprosum (ENL), a multicentre, double-blind, placebo-controlled randomised clinical trial conducted in Ethiopia, India, Indonesia and Nepal.

The trial evaluated the efficacy and safety of weekly oral methotrexate in combination with prednisolone compared with prednisolone alone for the treatment of ENL. The dataset includes demographic characteristics, clinical assessments, ENLIST ENL Severity Scale (EESS) scores, treatment allocation (de-identified), medication use, adverse events, laboratory results and health-related quality of life measures (Dermatology Life Quality Index [DLQI] and SF-36) collected during 60 weeks of follow-up.

Data availability

The study has removed direct identifiers, such as names, to protect participant confidentiality. However, it is recognized that some measures may still pose a re-identification risk when combined with other sources. To balance participant confidentiality with research reproducibility and data sharing conditions, access to data is managed through a safeguarded application process. Researchers are asked to complete an application form, specifying the variables they wish to access. This list will be reviewed to assess re-identification risks and determine any necessary anonymisation measures, such as grouping ages, broadening dates, or redacting text. Where full anonymisation is not possible, researchers will be required to sign a Data Transfer Agreement (DTA) that sets out data security requirements before access is granted.

Data codebook

The dataset contains 90 variables in total, outlined below.

Variable Name Variable Label Answer Label Answer Code Variable Type
Treatment Treatment arm     String
      Arm B  
      Arm A  
      Not Recruited  
study_id Patient study ID Open ended   String
sex Patient gender     Numeric
      1  
      2  
age Patient age Open ended   Numeric
enl_clas ENL type     Numeric
    acute 1  
    chronic or recurrent 2  
weight_kg Patient weight (Kg)     Numeric
height_cm Patient height (CM)     Numeric
bi_dgx bacterial intex at leprosy diagnosis      
    0 0  
    1 1  
    2 2  
    3 3  
    4 4  
    5 5  
    6 6  
    Missing 7  
ridley_jopling Classification (Ridley- Jopling)     Numeric
      0  
      1  
      2  
randomisation_date Date of randomisation Open ended   Date
scr_eess_score Current EESS score Open ended   Numeric
lab_measurement_date date of the measurement Open ended   Date
lab_aeYN Do you want to report an adverse event?     Numeric
    No 0  
    Yes 1  
laboratory_test Was laboratory test completed      
    Yes LFTs  
    No .  
Measurement_type Type of measurement     String
    Severity score severity score  
    Missing .  
eess_date Date of the severity scale Open ended   Date
eess_score Score of the severity scale Open ended   Numeric
value Value of the severity scale Open ended   Numeric
fu_date Follow-up visit date Open ended   Date
fu_sympt Compared to the last review, does the participant feel     Numeric
    Better 1  
    Somewhat better 2  
    Same 3  
    Somewhat worse 4  
    Worse 5  
fu_labsYN Did the participant have laboratory tests?     Numeric
    No 0  
    Yes 1  
    Missing .  
fu_mde_takenYN Has the participant taken all study medication?      
    No 0  
    Yes 1  
    Missing .  
fu_new_hist Any relevant new history? Open ended   String
fu_new_med Any new additional medications including steroids, dapsone-free MDT and analgesia since last visit? Open ended   String
fu_eess EESS score at follow-up      
fu_additional_pred Do you wish to prescribe additional prednisolone?     Numeric
    No 0  
    Yes 1  
fu_add_pred_reason If prescribing additional prednisolone, please indicate reason     Numeric
    not prescribed 0  
    ENL 1  
    new NFI 2  
    type 1 reaction 3  
fu_date Follow-up visit date Open ended   Date
fu_ae1YN Adverse event episode 1     Numeric
    No 0  
    Yes 1  
ae_date Date of adverse event Open ended   Date
ae_unplan_visitYN Is this an unplanned visit for adverse event?     Numeric
    No 0  
    Yes 1  
ae_type Type of adverse event (event 1) Open ended   String
ae_date_onset Date of onset (event 1) Open ended   Date
ae_seriousYN Is this a serious adverse event (event 1)     Numeric
    No 0  
    Yes 1  
ae_management How you managed the adverse event (event 1)     Numeric
    Stop medication 1  
    Decrease medication 2  
    Give medication for symptoms 3  
    Take participant out of the study 4  
    Hospitalisation 5  
ae_comments Comments on management of adverse events (event 1)   Open ended String
another_aeYN Do you want to report another adverse event?     Numeric
    No 0  
    Yes 1  
ae_2 Adverse event episode 2 Open ended   String
ae_date_onset2 Date of adverse event     Date
ae_serious2YN Is this a serious adverse event (event 2)     Numeric
    No 0  
    Yes 1  
ae_management2 How you managed the adverse event (event 2)     Numeric
    Stop medication 1  
    Decrease medication 2  
    Give medication for symptoms 3  
    Take participant out of the study 4  
ae_comments2 Comments on management of adverse events (event 2)   Open ended String
another_ae3 Do you want to report another adverse event?     Numeric
    No 0  
    Yes 1  
ae_date_onset3 Date of onset (event 3) Open ended   Date
ae_hospital_admissionYN Did the patient require hospital admission?     Numeric
    No 0  
    Yes 1  
ae_action Action related to severe adverse event Open ended   String
sae_onset_date Serious Adverse Event form SAE onset date     Date
sae_stop_date Serious Adverse Event Stop date     Date
unexp_saeYN What there an unexpected adverse event?     Numeric
    No 0  
    Yes 1  
description_sae Brief description of the nature of the Severe Adverse Event     String
death Patient has died     Numeric
    No 0  
    Yes 1  
life_threatening Was the adverse effect life threatening?     Numeric
    No 0  
    Yes 1  
    Missing .  
hospitalisation Patient was hospitalised     Numeric
    No 0  
    Yes 1  
disability Any type of disability due to severe adverse event      
    No 0  
    Missing .  
congenital_anomaly congenital anomaly     Numeric
    No 0  
    Yes 1  
    Missing .  
prevent_permant_impair Prevent permanent impairment     Numeric
    No 0  
    Yes 1  
    Missing .  
other Other factor noted (see other_spec for explanation)     Numeric
    No 0  
    Yes 1  
    Missing .  
other_spec If other, specify (if the severe adverse event is related to the drug being testing) Open ended   String
relat_sae Is the serious adverse event related to the intervention study?     Numeric
    Yes 1  
    No 2  
    Missing .  
sae_intervention_discontinueYN Was the study intervention discontinued due to event?     Numeric
    No 0  
    Yes 1  
    No adverse event .  
manage_sae What medications were used to treat the Severe Adverse Event (SAE)? Open ended   String
sae_treat What other steps were taken to treat the SAE?     Numeric
    Withdrawal of the study 1  
    Hospitalisation 2  
    Missing .  
relavent_data_sae List any relevant tests, laboratory data, and history, including pre-existing medical conditions Open ended   String
Measurement_type Type of measurement - Measurement Quality of Life - DLQI     String
    HRQL HRQL  
    Not recorded .  
dlqi_date Date of questionnaire Open ended   Date
dlqiscore Quality of life score Open ended   Numeric
value Value of the severity scale     String
    Score Unit score unit  
    Missing .  
Measurement_type Type of measurement - Measurement Quality of Life - SF36     String
    HRQL HRQL  
      %  
      .  
sf36_date Date of quality of life assessment     Date
PF SF-36 domains (PF) Open ended   Numeric
RP SF-36 domains (RP)     Numeric
RE SF-36 domains (RE) Open ended   Numeric
VT SF-36 domains (VT) Open ended   Numeric
MH SF-36 domains (MH) Open ended   Numeric
SF SF-36 domains (SF) Open ended   Numeric
BP SF-36 domains (BP) Open ended   Numeric
GH SF-36 domains (GH) Open ended   Numeric
value value of the severity scale     String
    Percentage %  
    Not recorded .  
term_date Study closure - completion or terminate date Open ended   Date
term_med Did the participant complete the full course of medication?     Numeric
    No 0  
    Yes 1  
term_add_pred Did the participant receive additional Prednisolone?     Numeric
    No 0  
    Yes 1  
term_add_pred_weeks If so, how many weeks (in total) did the participant receive Prednisolone? Open ended   Numeric
term_48wYN Did the participant report for examination during week 48     Numeric
    Yes 1  
    No 2  
    Undefined 38  
term_52wYN Did the participant report for examination during week 52     Numeric
    Yes 1  
    No 2  
    Undefined 38  
term_56wYN Did the participant report for examination during week 56     Numeric
    Yes 1  
    No 2  
    Undefined 38  
term_60wYN Did the participant report for examination during week 60     Numeric
    Yes 1  
    No 2  
    Undefined 38  
term_reason If the patient did not complete the medication or follow-up, select the reason     Numeric
    subject did not return for clinic visit 1  
    protocol violation 2  
    subject refused study procedures 3  
    voluntary withdrawal 4  
    Illness 5  
    death 6  
    severe adverse event 7  
    pregnancy 8  
    other reason 9  
term_other If other, specify Open ended   String
term_reason_details Further information on reason for not completing follow-up Open ended   String
term_comments Additional comments Open ended   String