{"id":"https://openalex.org/W7204231138","doi":"https://doi.org/10.1080/17843286.2026.2719664","title":"Early-onset respiratory adverse event patterns of omalizumab in pediatric patients: an age-stratified FAERS pharmacovigilance study","display_name":"Early-onset respiratory adverse event patterns of omalizumab in pediatric patients: an age-stratified FAERS pharmacovigilance study","publication_year":2026,"publication_date":"2026-08-26","ids":{"openalex":"https://openalex.org/W7204231138","doi":"https://doi.org/10.1080/17843286.2026.2719664","pmid":"https://pubmed.ncbi.nlm.nih.gov/42647060"},"language":"en","primary_location":{"id":"doi:10.1080/17843286.2026.2719664","doi":"https://doi.org/10.1080/17843286.2026.2719664","is_oa":false,"landing_page_url":"https://doi.org/10.1080/17843286.2026.2719664","pdf_url":null,"source":{"id":"https://openalex.org/S87184256","display_name":"Acta Clinica Belgica","issn_l":"1784-3286","issn":["1784-3286","2295-3337"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","medline","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Acta Clinica Belgica","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5128187418","display_name":"Hairui Zheng","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210116575","display_name":"Guangzhou First People's Hospital","ror":"https://ror.org/02bwytq13","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210116575"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Hairui Zheng","raw_affiliation_strings":["Guangzhou First People\u2019s Hospital"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Guangzhou First People\u2019s Hospital","institution_ids":["https://openalex.org/I4210116575"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5133623010","display_name":"Lu Liang","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210116575","display_name":"Guangzhou First People's Hospital","ror":"https://ror.org/02bwytq13","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210116575"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Lu Liang","raw_affiliation_strings":["Guangzhou First People\u2019s Hospital"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Guangzhou First People\u2019s Hospital","institution_ids":["https://openalex.org/I4210116575"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5128158020","display_name":"Ning Li","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210116575","display_name":"Guangzhou First People's Hospital","ror":"https://ror.org/02bwytq13","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210116575"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Ning Li","raw_affiliation_strings":["Guangzhou First People\u2019s Hospital"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Guangzhou First People\u2019s Hospital","institution_ids":["https://openalex.org/I4210116575"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5102334413","display_name":"Yi Su","orcid":"https://orcid.org/0009-0002-1596-119X","observed_orcids":["https://orcid.org/0009-0002-1596-119X"]},"institutions":[{"id":"https://openalex.org/I4210116575","display_name":"Guangzhou First People's Hospital","ror":"https://ror.org/02bwytq13","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210116575"]}],"countries":["CN"],"is_corresponding":true,"raw_author_name":"Yi Su","raw_affiliation_strings":["Guangzhou First People\u2019s Hospital"],"raw_orcid":"https://orcid.org/0009-0002-1596-119X","affiliations":[{"raw_affiliation_string":"Guangzhou First People\u2019s Hospital","institution_ids":["https://openalex.org/I4210116575"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5102334413"],"corresponding_institution_ids":["https://openalex.org/I4210116575"],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.68456376,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"1","last_page":"13"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.9976000189781189,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.9976000189781189,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10051","display_name":"Asthma and respiratory diseases","score":0.0010999999940395355,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11117","display_name":"Drug-Induced Adverse Reactions","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/omalizumab","display_name":"omalizumab","score":1.0},{"id":"https://openalex.org/keywords/respiratory-adverse-events","display_name":"respiratory adverse events","score":0.8169999718666077},{"id":"https://openalex.org/keywords/pediatric-patients","display_name":"pediatric patients","score":0.9100000262260437},{"id":"https://openalex.org/keywords/signal-detection","display_name":"signal detection","score":0.6380000114440918},{"id":"https://openalex.org/keywords/time-to-onset","display_name":"time to onset","score":0.6759999990463257},{"id":"https://openalex.org/keywords/asthma-exacerbations","display_name":"asthma exacerbations","score":0.8889999985694885},{"id":"https://openalex.org/keywords/drug-safety","display_name":"drug safety","score":0.6579999923706055}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9829000234603882},{"id":"https://openalex.org/C57658597","wikidata":"https://www.wikidata.org/wiki/Q1550789","display_name":"Pharmacovigilance","level":3,"score":0.7578999996185303},{"id":"https://openalex.org/C2777105317","wikidata":"https://www.wikidata.org/wiki/Q4686710","display_name":"Adverse Event Reporting System","level":3,"score":0.7045999765396118},{"id":"https://openalex.org/C2778564945","wikidata":"https://www.wikidata.org/wiki/Q415392","display_name":"Omalizumab","level":4,"score":0.6909000277519226},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.5468000173568726},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.4036000072956085},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.38580000400543213},{"id":"https://openalex.org/C194828623","wikidata":"https://www.wikidata.org/wiki/Q2861470","display_name":"Emergency medicine","level":1,"score":0.3822000026702881},{"id":"https://openalex.org/C2779662365","wikidata":"https://www.wikidata.org/wiki/Q5416694","display_name":"Event (particle physics)","level":2,"score":0.3725999891757965},{"id":"https://openalex.org/C187212893","wikidata":"https://www.wikidata.org/wiki/Q123028","display_name":"Pediatrics","level":1,"score":0.357699990272522},{"id":"https://openalex.org/C3020169349","wikidata":"https://www.wikidata.org/wiki/Q45959","display_name":"Adverse drug event","level":3,"score":0.33169999718666077},{"id":"https://openalex.org/C534529494","wikidata":"https://www.wikidata.org/wiki/Q7891","display_name":"Respiratory system","level":2,"score":0.29170000553131104}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.1080/17843286.2026.2719664","doi":"https://doi.org/10.1080/17843286.2026.2719664","is_oa":false,"landing_page_url":"https://doi.org/10.1080/17843286.2026.2719664","pdf_url":null,"source":{"id":"https://openalex.org/S87184256","display_name":"Acta Clinica Belgica","issn_l":"1784-3286","issn":["1784-3286","2295-3337"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","medline","poland-40","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Acta Clinica Belgica","raw_type":"journal-article"},{"id":"pmid:42647060","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/42647060","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Acta clinica Belgica","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":1.0,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"sustainable_development_goals_aurora":[{"score":0.6496791243553162,"id":"https://metadata.un.org/sdg/2","display_name":"Zero hunger"}],"study_designs":[{"id":"https://openalex.org/study-designs/observational-study","display_name":"Observational Study"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":15,"referenced_works":["https://openalex.org/W1898930241","https://openalex.org/W2061775758","https://openalex.org/W2608178729","https://openalex.org/W2767568586","https://openalex.org/W2900203670","https://openalex.org/W2923450011","https://openalex.org/W2989689096","https://openalex.org/W3005931313","https://openalex.org/W3123689819","https://openalex.org/W4220739866","https://openalex.org/W4307457797","https://openalex.org/W4309842527","https://openalex.org/W4383480896","https://openalex.org/W4404321999","https://openalex.org/W4415455036"],"related_works":[],"abstract_inverted_index":{"OBJECTIVES:":[0],"To":[1],"compare":[2],"age-specific":[3],"respiratory":[4,135,199,220],"adverse":[5],"event":[6],"(AE)":[7],"reporting":[8,201],"patterns":[9],"associated":[10],"with":[11,58,77,82,184,225],"omalizumab":[12],"in":[13,127,174,197,222],"pediatric":[14,50,149,175,223],"and":[15,74,110,118,121,142,163,202],"adult":[16,54],"patients":[17,176],"using":[18],"FAERS,":[19],"interpreting":[20],"findings":[21],"as":[22,49,93],"signal-detection":[23],"rather":[24],"than":[25,177],"causal":[26],"or":[27,53,213],"incidence":[28],"evidence.":[29],"METHODS:":[30],"FAERS":[31,192],"reports":[32,57,79,132,193],"for":[33],"omalizumab/Xolair":[34],"from":[35,65],"Q1":[36],"2004":[37],"to":[38],"Q4":[39],"2025":[40],"were":[41,47,61,80,106,125],"analyzed":[42],"after":[43],"FDA-recommended":[44],"deduplication.":[45],"Reports":[46],"stratified":[48],"(<18":[51],"years)":[52],"(\u226518":[55],"years);":[56],"missing":[59],"age":[60,114],"described":[62],"but":[63,216],"excluded":[64],"age-stratified":[66],"comparisons.":[67],"Signal":[68],"detection":[69],"used":[70],"ROR,":[71],"PRR,":[72],"BCPNN/IC,":[73],"MGPS/EBGM.":[75],"PTs":[76],"\u22653":[78],"evaluated,":[81],"emphasis":[83],"on":[84],"signals":[85,207],"concordant":[86],"across":[87],"algorithms.":[88],"Early":[89],"onset":[90,173],"was":[91],"predefined":[92],"valid":[94],"time-to-onset":[95],"(TTO)":[96],"\u2264100":[97],"days.":[98,190],"RESULTS:":[99],"Among":[100],"62,925":[101],"omalizumab-associated":[102,198],"AE":[103,200],"reports,":[104],"2,792":[105],"pediatric,":[107],"28,075":[108],"adult,":[109],"32,058":[111],"(50.94%)":[112],"lacked":[113],"information.":[115],"Respiratory,":[116],"thoracic":[117],"mediastinal":[119],"disorders":[120,124],"immune":[122],"system":[123],"prominent":[126],"both":[128],"age-known":[129],"groups.":[130],"Pediatric":[131],"showed":[133,147],"concentrated":[134],"PTs,":[136],"including":[137],"asthma,":[138],"dyspnoea,":[139],"cough,":[140],"wheezing,":[141],"asthmatic":[143],"crisis.":[144],"Asthmatic":[145],"crisis":[146],"strong":[148],"disproportionality,":[150],"although":[151],"this":[152],"may":[153],"reflect":[154],"underlying":[155],"asthma":[156],"severity,":[157],"exacerbation,":[158],"treatment":[159],"failure,":[160],"differential":[161],"reporting,":[162],"potential":[164],"drug-related":[165],"events.":[166],"Valid":[167],"TTO":[168,203],"records":[169],"indicated":[170],"earlier":[171],"reported":[172],"adults":[178],"(median:":[179],"34.4":[180],"vs.":[181],"63.1":[182],"days),":[183],"clustering":[185],"within":[186],"the":[187],"first":[188],"100":[189],"CONCLUSION:":[191],"suggest":[194],"age-related":[195],"differences":[196],"patterns.":[204],"These":[205],"hypothesis-generating":[206],"do":[208],"not":[209],"establish":[210],"causality,":[211],"incidence,":[212],"risk":[214],"magnitude":[215],"support":[217],"closer":[218],"early":[219],"monitoring":[221],"patients,":[224],"careful":[226],"consideration":[227],"of":[228],"indication-related":[229],"confounding.":[230]},"counts_by_year":[],"updated_date":"2026-10-13T10:08:12.033832","created_date":"2026-08-27T00:00:00"}
