{"id":"https://openalex.org/W4399799455","doi":"https://doi.org/10.1007/s10875-024-01742-5","title":"Tolerability and Safety of Large-Volume Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% Administered with or without Dose Ramp-Up: A Phase 1 Study in Healthy Participants","display_name":"Tolerability and Safety of Large-Volume Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% Administered with or without Dose Ramp-Up: A Phase 1 Study in Healthy Participants","publication_year":2024,"publication_date":"2024-06-19","ids":{"openalex":"https://openalex.org/W4399799455","doi":"https://doi.org/10.1007/s10875-024-01742-5","pmid":"https://pubmed.ncbi.nlm.nih.gov/38896141","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/11186899"},"language":"en","primary_location":{"id":"doi:10.1007/s10875-024-01742-5","doi":"https://doi.org/10.1007/s10875-024-01742-5","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s10875-024-01742-5","pdf_url":null,"source":{"id":"https://openalex.org/S57504206","display_name":"Journal of Clinical Immunology","issn_l":"0271-9142","issn":["0271-9142","1573-2592"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Immunology","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://doi.org/10.1007/s10875-024-01742-5","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5100457054","display_name":"Zhaoyang Li","orcid":"https://orcid.org/0000-0003-4625-1107","observed_orcids":["https://orcid.org/0000-0003-4625-1107"]},"institutions":[{"id":"https://openalex.org/I4210140176","display_name":"Takeda (United States)","ror":"https://ror.org/03bygaq51","country_code":"US","type":"company","lineage":["https://openalex.org/I4210140176","https://openalex.org/I44892455"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Zhaoyang Li","raw_affiliation_strings":["Takeda Development Center Americas, Inc, Cambridge, MA, USA. zhaoyang.li@takeda.com","Takeda Development Center Americas, Inc, Cambridge, MA, USA"],"raw_orcid":"https://orcid.org/0000-0003-4625-1107","affiliations":[{"raw_affiliation_string":"Takeda Development Center Americas, Inc, Cambridge, MA, USA. zhaoyang.li@takeda.com","institution_ids":["https://openalex.org/I4210140176"]},{"raw_affiliation_string":"Takeda Development Center Americas, Inc, Cambridge, MA, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5011105258","display_name":"Andr\u00e1s Nagy","orcid":"https://orcid.org/0000-0003-4311-0413","observed_orcids":["https://orcid.org/0000-0003-4311-0413"]},"institutions":[{"id":"https://openalex.org/I4210156998","display_name":"Takeda (Austria)","ror":"https://ror.org/04nm3yk20","country_code":"AT","type":"company","lineage":["https://openalex.org/I4210156998","https://openalex.org/I44892455"]}],"countries":["AT"],"is_corresponding":false,"raw_author_name":"Andras Nagy","raw_affiliation_strings":["Baxalta Innovations GmbH, a Takeda company, Vienna, Austria"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Baxalta Innovations GmbH, a Takeda company, Vienna, Austria","institution_ids":["https://openalex.org/I4210156998"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Dirk Lindner","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Dirk Lindner","raw_affiliation_strings":["Takeda Development Center Americas, Inc, Cambridge, MA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Takeda Development Center Americas, Inc, Cambridge, MA, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5062212751","display_name":"Kimberly Duff","orcid":"https://orcid.org/0009-0000-3657-5293","observed_orcids":["https://orcid.org/0009-0000-3657-5293"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Kim Duff","raw_affiliation_strings":["Takeda Development Center Americas, Inc, Cambridge, MA, USA"],"raw_orcid":"https://orcid.org/0009-0000-3657-5293","affiliations":[{"raw_affiliation_string":"Takeda Development Center Americas, Inc, Cambridge, MA, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":null,"display_name":"Enrique Garcia","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Enrique Garcia","raw_affiliation_strings":["Takeda Development Center Americas, Inc, Cambridge, MA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Takeda Development Center Americas, Inc, Cambridge, MA, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5102897743","display_name":"Hakan Ay","orcid":"https://orcid.org/0000-0002-9146-0218","observed_orcids":["https://orcid.org/0000-0002-9146-0218"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Hakan Ay","raw_affiliation_strings":["Takeda Development Center Americas, Inc, Cambridge, MA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Takeda Development Center Americas, Inc, Cambridge, MA, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5071766381","display_name":"Juan Carlos Rond\u00f3n","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210123890","display_name":"Clinical Pharmacology of Miami","ror":"https://ror.org/02wvtac27","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210123890"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Juan Carlos Rondon","raw_affiliation_strings":["Clinical Pharmacology of Miami, LLC, Miami, FL, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Pharmacology of Miami, LLC, Miami, FL, USA","institution_ids":["https://openalex.org/I4210123890"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5058777943","display_name":"Leman Yel","orcid":"https://orcid.org/0000-0001-8357-3186","observed_orcids":["https://orcid.org/0000-0001-8357-3186"]},"institutions":[{"id":"https://openalex.org/I204250578","display_name":"University of California, Irvine","ror":"https://ror.org/04gyf1771","country_code":"US","type":"education","lineage":["https://openalex.org/I204250578"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Leman Yel","raw_affiliation_strings":["Takeda Development Center Americas, Inc, Cambridge, MA, USA","University of California, Irvine, CA, USA"],"raw_orcid":"https://orcid.org/0000-0001-8357-3186","affiliations":[{"raw_affiliation_string":"Takeda Development Center Americas, Inc, Cambridge, MA, USA","institution_ids":[]},{"raw_affiliation_string":"University of California, Irvine, CA, USA","institution_ids":["https://openalex.org/I204250578"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":4,"corresponding_author_ids":["https://openalex.org/A5100457054"],"corresponding_institution_ids":["https://openalex.org/I4210140176"],"apc_list":{"value":4990,"currency":"USD","value_usd":4990},"apc_paid":{"value":4990,"currency":"USD","value_usd":4990},"fwci":0.6337,"has_fulltext":true,"cited_by_count":4,"citation_normalized_percentile":{"value":0.62378341,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":98},"biblio":{"volume":"44","issue":"7","first_page":"148","last_page":"148"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11725","display_name":"Immunodeficiency and Autoimmune Disorders","score":0.30640000104904175,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T11725","display_name":"Immunodeficiency and Autoimmune Disorders","score":0.30640000104904175,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11016","display_name":"Monoclonal and Polyclonal Antibodies Research","score":0.1720000058412552,"subfield":{"id":"https://openalex.org/subfields/2741","display_name":"Radiology, Nuclear Medicine and Imaging"},"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":0.05180000141263008,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology (medical)"},"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/recombinant-human-hyaluronidase","display_name":"recombinant human hyaluronidase","score":0.8899999856948853},{"id":"https://openalex.org/keywords/rhuph20","display_name":"rHuPH20","score":0.9259999990463257},{"id":"https://openalex.org/keywords/infusion-safety","display_name":"infusion safety","score":0.7860000133514404},{"id":"https://openalex.org/keywords/treatment-emergent-adverse-events","display_name":"treatment-emergent adverse events","score":0.925000011920929},{"id":"https://openalex.org/keywords/primary-immunodeficiency","display_name":"primary immunodeficiency","score":0.7710000276565552}],"concepts":[{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.956011176109314},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7892403602600098},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.7227389812469482},{"id":"https://openalex.org/C2777288759","wikidata":"https://www.wikidata.org/wiki/Q4164182","display_name":"Dosing","level":2,"score":0.6559522151947021},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.5301103591918945},{"id":"https://openalex.org/C2778715236","wikidata":"https://www.wikidata.org/wiki/Q55622662","display_name":"Discontinuation","level":2,"score":0.488166868686676},{"id":"https://openalex.org/C42219234","wikidata":"https://www.wikidata.org/wiki/Q131130","display_name":"Anesthesia","level":1,"score":0.46734291315078735},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.32559823989868164},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.31689053773880005}],"mesh":[{"descriptor_ui":"D000293","descriptor_name":"Adolescent","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006821","descriptor_name":"Hyaluronoglucosaminidase","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D006821","descriptor_name":"Hyaluronoglucosaminidase","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D007136","descriptor_name":"Immunoglobulins","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D007136","descriptor_name":"Immunoglobulins","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011994","descriptor_name":"Recombinant Proteins","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D011994","descriptor_name":"Recombinant Proteins","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D055104","descriptor_name":"Infusions, Subcutaneous","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D055815","descriptor_name":"Young Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D064368","descriptor_name":"Healthy Volunteers","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":4,"locations":[{"id":"doi:10.1007/s10875-024-01742-5","doi":"https://doi.org/10.1007/s10875-024-01742-5","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s10875-024-01742-5","pdf_url":null,"source":{"id":"https://openalex.org/S57504206","display_name":"Journal of Clinical Immunology","issn_l":"0271-9142","issn":["0271-9142","1573-2592"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Immunology","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:11186899","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/11186899","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11186899/pdf/10875_2024_Article_1742.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"J Clin Immunol","raw_type":"Text"},{"id":"pmid:38896141","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/38896141","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":"Journal of clinical immunology","raw_type":"Journal Article"},{"id":"pmh:oai:escholarship.org:ark:/13030/qt71p932gw","doi":null,"is_oa":true,"landing_page_url":"https://escholarship.org/uc/item/71p932gw","pdf_url":"https://escholarship.org/content/qt71p932gw/qt71p932gw.pdf","source":{"id":"https://openalex.org/S4306400115","display_name":"eScholarship (California Digital Library)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I2801248553","host_organization_name":"California Digital Library","host_organization_lineage":["https://openalex.org/I2801248553"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Journal of Clinical Immunology, vol 44, iss 7","raw_type":"article"}],"best_oa_location":{"id":"doi:10.1007/s10875-024-01742-5","doi":"https://doi.org/10.1007/s10875-024-01742-5","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s10875-024-01742-5","pdf_url":null,"source":{"id":"https://openalex.org/S57504206","display_name":"Journal of Clinical Immunology","issn_l":"0271-9142","issn":["0271-9142","1573-2592"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Immunology","raw_type":"journal-article"},"sustainable_development_goals":[{"score":1.0,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320311257","display_name":"Baxalta","ror":"https://ror.org/040fqas51"},{"id":"https://openalex.org/F4320333965","display_name":"Takeda Pharmaceuticals International","ror":"https://ror.org/002ysmy84"}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4399799455.pdf","grobid_xml":"https://content.openalex.org/works/W4399799455.grobid-xml"},"referenced_works_count":16,"referenced_works":["https://openalex.org/W1655974874","https://openalex.org/W1965431513","https://openalex.org/W1967295501","https://openalex.org/W2000948356","https://openalex.org/W2035488076","https://openalex.org/W2094456879","https://openalex.org/W2094655231","https://openalex.org/W2131979077","https://openalex.org/W2753160699","https://openalex.org/W2785910756","https://openalex.org/W3009112719","https://openalex.org/W3078996272","https://openalex.org/W3137366009","https://openalex.org/W3157122632","https://openalex.org/W3186523768","https://openalex.org/W4380577412"],"related_works":["https://openalex.org/W4377695524","https://openalex.org/W4367303280","https://openalex.org/W4377695856","https://openalex.org/W4390080379","https://openalex.org/W2062159866","https://openalex.org/W7128811895","https://openalex.org/W4399775833","https://openalex.org/W4402584309","https://openalex.org/W2895418749","https://openalex.org/W4401707248"],"abstract_inverted_index":{"PURPOSE:":[0],"Facilitated":[1],"subcutaneous":[2,17],"immunoglobulin":[3,18],"(fSCIG;":[4],"immune":[5],"globulin":[6],"infusion":[7,22,38,125],"10%":[8,81,151,215,224],"[human]":[9],"with":[10,82,88,222,225],"recombinant":[11],"human":[12],"hyaluronidase":[13],"[rHuPH20])":[14],"permits":[15],"high-volume":[16],"(SCIG)":[19],"infusion,":[20],"shorter":[21],"times":[23],"and":[24,77,188,210],"reduced":[25,160],"dosing":[26],"frequency":[27],"relative":[28],"to":[29,44,98,105,129,165,231,241],"conventional":[30,89,171,186],"SCIG.":[31],"It":[32],"is":[33],"initiated":[34,153],"by":[35],"gradually":[36],"increasing":[37],"volumes":[39],"over":[40,58],"time":[41],"(dose":[42],"ramp-up)":[43],"achieve":[45,106],"target":[46],"dose":[47],"level":[48],"(TDL).":[49],"Whether":[50],"ramp-up":[51,86,90,103,172,181,227,237],"strategies":[52],"have":[53],"tolerability":[54,76,209],"or":[55,84,110,124],"safety":[56,78,211],"advantages":[57],"direct":[59],"initiation":[60],"at":[61,192,228,238],"full":[62],"TDL":[63],"has":[64],"not":[65,200],"been":[66],"evaluated":[67],"clinically.":[68],"METHODS:":[69],"This":[70],"phase":[71],"1":[72],"open-label":[73],"study":[74],"assessed":[75,136],"of":[79,100,108,119,213],"fSCIG":[80,150,214,223],"accelerated":[83,189,226],"no":[85,180,236],"compared":[87],"in":[91,161,167,178,216],"healthy":[92,217],"adults":[93],"(NCT04578535).":[94],"Participants":[95],"were":[96,176],"assigned":[97],"one":[99,162],"the":[101,117,168,179,185,193],"three":[102],"arms":[104,191],"TDLs":[107,229,239],"0.4":[109,169,242],"1.0":[111,194,232],"g/kg/infusion.":[112],"The":[113,207],"primary":[114],"endpoint":[115],"was":[116,135,159],"proportion":[118],"infusions":[120,152],"completed":[121],"without":[122],"interruption":[123],"rate":[126,158],"reduction":[127],"owing":[128,164],"treatment-emergent":[130],"adverse":[131],"events":[132],"(TEAEs).":[133],"Safety":[134,197],"as":[137],"a":[138],"secondary":[139],"endpoint.":[140],"RESULTS:":[141],"Of":[142],"51":[143],"participants":[144,218],"enrolled,":[145],"50":[146],"(98.0%)":[147],"tolerated":[148],"all":[149],"(n":[154],"=":[155],"174).":[156],"Infusion":[157],"participant":[163],"headache":[166],"g/kg/infusion":[170,195],"arm.":[173],"Study":[174],"discontinuations":[175],"higher":[177,250],"arm":[182],"(70%)":[183],"versus":[184],"(0%)":[187],"(22%)":[190],"TDL.":[196],"outcomes":[198],"did":[199],"substantially":[201],"differ":[202],"between":[203],"treatment":[204,221],"arms.":[205],"CONCLUSION:":[206],"favorable":[208],"profiles":[212],"support":[219,235],"initiating":[220],"up":[230],"g/kg.":[233],"Data":[234],"close":[240],"g/kg":[243],"but":[244],"additional":[245],"data":[246],"are":[247],"needed":[248],"for":[249],"doses.":[251]},"counts_by_year":[{"year":2026,"cited_by_count":3},{"year":2024,"cited_by_count":1}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2024-06-20T00:00:00"}
