[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659647":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":16,"studyPopulation":56,"armGroups":57,"interventions":63,"overallOfficials":69,"centralContacts":73,"locations":81,"responsibleParty":102,"collaborators":16,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":16,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":16,"enrollmentInfo":113,"targetDuration":16,"studyType":116,"phases":16,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":122,"whyStopped":16,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Takeda","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants With Hematologic Malignancies Who Meet the Protocol-defined SID Criteria","The percentage of participants with hematologic malignancies who meet the protocol-defined SID criteria will be reported. SID is defined as IgG \\\u003C5 g\u002FL, proven specific antibody failure, and\u002For a history of severe or recurrent infections. Each participant will be assessed from the start of available EHR data until the earliest of the last available EHR, follow-up, death, or the retrospective data cut-off date. Cut-off date, is defined as the final date of data availability included in the study dataset, corresponding to the initiation of data extraction from the EHR\u002Fregistry: all eligible participant data recorded in the EHR\u002Fregistry up to and including this date will be considered for analysis.","Up to 6 years",[14,17,19,21,23,25,27,29,31,33,35,37,39,41,43,45,47,49,51],{"measure":15,"description":16,"timeFrame":12},"Number of Infection Episodes During the Post-index Observation Period",null,{"measure":18,"description":16,"timeFrame":12},"Frequency of Infection Episodes During the Post-index Observation Period",{"measure":20,"description":16,"timeFrame":12},"Number of Participants Receiving Antibiotic or Antimicrobial Therapy",{"measure":22,"description":16,"timeFrame":12},"Overall Hospitalization Rate",{"measure":24,"description":16,"timeFrame":12},"Infection-related Hospitalization Rate",{"measure":26,"description":16,"timeFrame":12},"Number of Participants who had Intensive Care Unit (ICU) Admissions",{"measure":28,"description":16,"timeFrame":12},"Number of Participants With Emergency Department Visits",{"measure":30,"description":16,"timeFrame":12},"Length of Hospital Stay",{"measure":32,"description":16,"timeFrame":12},"Percentage of Participants With Hospital Readmission Within 30 Days",{"measure":34,"description":16,"timeFrame":12},"Duration of Receiving Intravenous (IV) or Subcutaneous (SC) Immunoglobulin Replacement Therapy (IgRT)",{"measure":36,"description":16,"timeFrame":12},"Number of Participants Receiving Prophylactic Antibiotics or Antivirals",{"measure":38,"description":16,"timeFrame":12},"Number of Diagnostic Tests and Monitoring Assessments for SID",{"measure":40,"description":16,"timeFrame":12},"Number of Participants Categorized by SID Severity",{"measure":42,"description":16,"timeFrame":12},"Number of Participants With Comorbidities",{"measure":44,"description":16,"timeFrame":12},"Number of Participants Categorized by Hematologic Malignancy Subtype",{"measure":46,"description":16,"timeFrame":12},"Number of Participants Categorized by Disease Characteristics",{"measure":48,"description":16,"timeFrame":12},"Number of Participants Categorized by Oncology Therapy Exposure",{"measure":50,"description":16,"timeFrame":12},"Number of Participants Categorized by Type of Oncology Therapy",{"measure":52,"description":16,"timeFrame":12},"Number of Participants Categorized by IgRT Subgroup",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":54,"timePerspective":55,"maskingInfo":16},"COHORT","RETROSPECTIVE","The study population will include participants who have been diagnosed with HM and documented SID and\u002For evidence meeting the study SID definition. The participants must be treated at the National Oncology Center (Astana) with available EHR data in the Kazakhstan National Oncology Registry\u002FEHR.",[58],{"label":59,"type":16,"description":60,"interventionNames":61},"HM participants with SID","Adult participants with a hematologic malignancy treated at the National Oncology Center (Astana) and recorded in the Kazakhstan National Oncology Registry\u002Felectronic health record (EHR) will be included. Eligible participants must have a documented diagnosis of SID and\u002For evidence meeting the protocol-defined SID criteria, defined by immunoglobulin (IgG) less than (\\\u003C) 5 grams per liter (g\u002FL), specific antibody failure, or severe\u002Frecurrent infections. Data from January 2021 until study start (estimated April 2027) will be evaluated.",[62],"Other: No Intervention",[64],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":16},"OTHER","No Intervention","This is a non-interventional study.",[59],[70],{"name":71,"affiliation":5,"role":72},"Study Director","STUDY_DIRECTOR",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":16,"email":78},"Takeda Contact","CONTACT","+1-877-825-3327","medinfoUS@takeda.com",{"name":80,"role":76,"phone":16,"phoneExt":16,"email":16},"Director",[82],{"facility":83,"status":16,"city":84,"state":16,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"National Research Oncology Center","Astana","Z05T6H4","Kazakhstan","KZ",{"type":89,"coordinates":90},"Point",[91,92],71.44598,51.1801,{"lat":92,"lon":91},[95,99],{"name":96,"role":76,"phone":97,"phoneExt":16,"email":98},"Site Contact","+7 (7172) 57-08-67","kense@cancercenter.kz",{"name":100,"role":101,"phone":16,"phoneExt":16,"email":16},"Azat Karabekov","PRINCIPAL_INVESTIGATOR",{"type":103,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100659647","a-study-of-secondary-immunodeficiencies-in-adults-with-blood-cancers-in-kazakhstan-who-have-a-weakened-immune-system-k-side-study-100659647",false,"NCT07868107","A Study of Secondary Immunodeficiencies in Adults With Blood Cancers in Kazakhstan Who Have a Weakened Immune System (K-SIDE Study)","Epidemiology, Clinical Burden, and Practice Patterns of Secondary Immunodeficiencies in Hematologic Malignancies: A Retrospective Analysis of Electronic Health Records in Kazakhstan","Inclusion Criteria: Participants must meet all of the following criteria:\n\n* Adults greater than or equal to (\\>=)18 years of age.\n* Confirmed diagnosis of a hematologic malignancy (preceding SID diagnosis and\u002For evidence, as defined in inclusion criterion 4), including but not limited to:\n\n  * Multiple Myeloma\n  * Chronic Lymphocytic Leukemia\n  * Non-Hodgkin Lymphoma\n  * Acute Leukemia\n  * Myeloproliferative Neoplasm\n* Available EHR data within the study observation period.\n* For the SID cohort: confirmed diagnosis of SID OR evidence of secondary immunodeficiency, defined by one or more of the following:\n\n  * Serum IgG \\\u003C5 g\u002FL, and\u002For\n  * Proven Specific Antibody Failure (PSAF), and\u002For\n  * History of severe or recurrent infections, defined as:\n\n    * \\>=3 infections per annum requiring treatment with antibiotics (ideally microbiologically proven), and\u002For\n    * Radiologically proven pneumonia, and\u002For\n    * Culture-proven sepsis or febrile neutropenia, and\u002For\n    * Other infection requiring hospitalization and IV antibiotics\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n* Age \\\u003C18 years.\n* Primary immunodeficiency (PID) diagnosis.\n* No available EHR data within the study observation period.\n* Previous enrolment in a therapeutic investigational drug or device trial during the study observation period.","ALL","18 Years",{"count":114,"type":115},200,"ESTIMATED","OBSERVATIONAL","Some people with blood cancers (hematologic malignancies) develop a weakened immune system because of their condition or the medicines used to treat it. This is called a secondary immunodeficiency or SID. A weakened immune system can make it harder for the body to fight infections. SIDs make participants more likely to have serious infections, need treatment at a hospital, and need longer treatment periods with antibiotics. SIDs are common but often overlooked in people with blood cancers in Kazakhstan. Currently, Kazakhstan does not have national guidelines for diagnosing and managing SIDs, which leads to differences in how people are assessed and treated across healthcare settings.\n\nThe main aim of this study is to understand how common SIDs are in adults with blood cancers in Kazakhstan, which people are most affected and how often related health problems such as infections happen. Other aims are to learn more about SIDs in Kazakhstan: how SIDs are treated, how they affect a person's health and daily life (clinical burden) and how certain factors (such as age, health condition, treatment, type and stage of the blood cancer) may influence SIDs.\n\nThis study will not collect any new data. It will use existing health records and data from Kazakhstan's national oncology registry.",[119],"Secondary Immunodeficiency (SID)",[121],"Drug Therapy","NOT_YET_RECRUITING","2026-10-05",{"date":125,"type":126},"2026-10-09","ACTUAL",{"date":128,"type":115},"2027-04-01",{"date":130,"type":115},"2027-09-30",{"name":5,"class":6},1]