{"id":"https://openalex.org/W2979255693","doi":"https://doi.org/10.14309/00000434-201210001-01733","title":"9-Year Evaluation of Temporal Trends in Alosetron Postmarketing Safety Under the Risk Management Program","display_name":"9-Year Evaluation of Temporal Trends in Alosetron Postmarketing Safety Under the Risk Management Program","publication_year":2012,"publication_date":"2012-10-01","ids":{"openalex":"https://openalex.org/W2979255693","doi":"https://doi.org/10.14309/00000434-201210001-01733","mag":"2979255693"},"language":"en","primary_location":{"id":"doi:10.14309/00000434-201210001-01733","doi":"https://doi.org/10.14309/00000434-201210001-01733","is_oa":false,"landing_page_url":"https://doi.org/10.14309/00000434-201210001-01733","pdf_url":null,"source":{"id":"https://openalex.org/S66441642","display_name":"The American Journal of Gastroenterology","issn_l":"0002-9270","issn":["0002-9270","1572-0241"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American Journal of Gastroenterology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"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/A5101979218","display_name":"Lin Chang","orcid":"https://orcid.org/0000-0003-3598-3310","observed_orcids":["https://orcid.org/0000-0003-3598-3310"]},"institutions":[{"id":"https://openalex.org/I161318765","display_name":"University of California, Los Angeles","ror":"https://ror.org/046rm7j60","country_code":"US","type":"education","lineage":["https://openalex.org/I161318765"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Lin Chang","raw_affiliation_strings":[". Center for Neurobiology Stress, Division of Digestive Diseases, Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, CA","Medical Affairs 360, San Diego, CA, USA","Oppenheimer Family Center for Neurobiology of Stress, Division of Digestive Diseases, David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, CHS 42-210, Los Angeles, CA 90095-7378, USA","Prometheus Laboratories Inc., San Diego, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":". Center for Neurobiology Stress, Division of Digestive Diseases, Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, CA","institution_ids":["https://openalex.org/I161318765"]},{"raw_affiliation_string":"Medical Affairs 360, San Diego, CA, USA","institution_ids":[]},{"raw_affiliation_string":"Oppenheimer Family Center for Neurobiology of Stress, Division of Digestive Diseases, David Geffen School of Medicine at UCLA, 10833 Le Conte Avenue, CHS 42-210, Los Angeles, CA 90095-7378, USA","institution_ids":["https://openalex.org/I161318765"]},{"raw_affiliation_string":"Prometheus Laboratories Inc., San Diego, CA, USA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5017981196","display_name":"Kenneth Tong","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Kenneth Tong","raw_affiliation_strings":["Prometheus Laboratories Inc., San Diego, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Prometheus Laboratories Inc., San Diego, CA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5024034724","display_name":"Reshma Shringarpure","orcid":"https://orcid.org/0000-0001-5936-0447","observed_orcids":["https://orcid.org/0000-0001-5936-0447"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Reshma Shringarpure","raw_affiliation_strings":["Prometheus Laboratories Inc., San Diego, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Prometheus Laboratories Inc., San Diego, CA","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5011843783","display_name":"Emil Chuang","orcid":"https://orcid.org/0000-0003-1070-6595","observed_orcids":["https://orcid.org/0000-0003-1070-6595"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Emil Chuang","raw_affiliation_strings":["Prometheus Laboratories Inc., San Diego, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Prometheus Laboratories Inc., San Diego, CA","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5077632073","display_name":"Jean Paul Nicandro","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Jean Paul Nicandro","raw_affiliation_strings":["Prometheus Laboratories Inc., San Diego, CA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Prometheus Laboratories Inc., San Diego, CA","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5101979218"],"corresponding_institution_ids":["https://openalex.org/I161318765"],"apc_list":{"value":4390,"currency":"USD","value_usd":4390},"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":1,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":87,"max":93},"biblio":{"volume":"107","issue":null,"first_page":"S703","last_page":"S704"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.9717000126838684,"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":0.9717000126838684,"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/T10365","display_name":"Gastrointestinal motility and disorders","score":0.00570000009611249,"subfield":{"id":"https://openalex.org/subfields/2715","display_name":"Gastroenterology"},"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/T10134","display_name":"Inflammatory Bowel Disease","score":0.003800000064074993,"subfield":{"id":"https://openalex.org/subfields/2715","display_name":"Gastroenterology"},"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/alosetron","display_name":"alosetron","score":0.996999979019165},{"id":"https://openalex.org/keywords/ischemic-colitis","display_name":"ischemic colitis","score":0.8379999995231628},{"id":"https://openalex.org/keywords/risk-management-program","display_name":"risk management program","score":0.6940000057220459},{"id":"https://openalex.org/keywords/rems","display_name":"REMS","score":0.628000020980835},{"id":"https://openalex.org/keywords/post-marketing-safety","display_name":"post-marketing safety","score":0.7099999785423279},{"id":"https://openalex.org/keywords/adverse-event-incidence","display_name":"adverse event incidence","score":0.5730000138282776},{"id":"https://openalex.org/keywords/diarrhea-predominant-irritable-bowel-syndrome","display_name":"diarrhea-predominant irritable bowel syndrome","score":0.8130000233650208},{"id":"https://openalex.org/keywords/5-ht3-receptor-antagonists","display_name":"5-HT3 receptor antagonists","score":0.8550000190734863},{"id":"https://openalex.org/keywords/temporal-trends","display_name":"temporal trends","score":0.6600000262260437},{"id":"https://openalex.org/keywords/fda-medwatch","display_name":"FDA MedWatch","score":0.6290000081062317},{"id":"https://openalex.org/keywords/pharmacovigilance","display_name":"pharmacovigilance","score":0.5320000052452087},{"id":"https://openalex.org/keywords/cumulative-incidence-rate","display_name":"cumulative incidence rate","score":0.40400001406669617},{"id":"https://openalex.org/keywords/95-confidence-interval","display_name":"95% confidence interval","score":0.4320000112056732},{"id":"https://openalex.org/keywords/95th-percentile","display_name":"95th percentile","score":0.4959999918937683}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9912739992141724},{"id":"https://openalex.org/C197636746","wikidata":"https://www.wikidata.org/wiki/Q7234359","display_name":"Postmarketing surveillance","level":3,"score":0.6330195665359497},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.5693873763084412},{"id":"https://openalex.org/C2778435480","wikidata":"https://www.wikidata.org/wiki/Q840387","display_name":"Colonoscopy","level":4,"score":0.5552154779434204},{"id":"https://openalex.org/C2779896975","wikidata":"https://www.wikidata.org/wiki/Q941169","display_name":"Sigmoidoscopy","level":5,"score":0.4722328186035156},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.4684208631515503},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.33094847202301025},{"id":"https://openalex.org/C526805850","wikidata":"https://www.wikidata.org/wiki/Q188874","display_name":"Colorectal cancer","level":3,"score":0.20340433716773987},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.07999095320701599}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.14309/00000434-201210001-01733","doi":"https://doi.org/10.14309/00000434-201210001-01733","is_oa":false,"landing_page_url":"https://doi.org/10.14309/00000434-201210001-01733","pdf_url":null,"source":{"id":"https://openalex.org/S66441642","display_name":"The American Journal of Gastroenterology","issn_l":"0002-9270","issn":["0002-9270","1572-0241"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American Journal of Gastroenterology","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":1.0,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Observational Study","id":"https://openalex.org/study-designs/observational-study"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":34,"referenced_works":["https://openalex.org/W1854805108","https://openalex.org/W1966226295","https://openalex.org/W1968880098","https://openalex.org/W1971221760","https://openalex.org/W1983583112","https://openalex.org/W1987655442","https://openalex.org/W1993764725","https://openalex.org/W1996004649","https://openalex.org/W1997799955","https://openalex.org/W2002414046","https://openalex.org/W2005714828","https://openalex.org/W2007655479","https://openalex.org/W2017842002","https://openalex.org/W2020745528","https://openalex.org/W2027453870","https://openalex.org/W2031072115","https://openalex.org/W2035889417","https://openalex.org/W2044067755","https://openalex.org/W2064470823","https://openalex.org/W2067430156","https://openalex.org/W2077365630","https://openalex.org/W2078229815","https://openalex.org/W2087399526","https://openalex.org/W2088470278","https://openalex.org/W2091815199","https://openalex.org/W2107924210","https://openalex.org/W2109750196","https://openalex.org/W2121010946","https://openalex.org/W2121184314","https://openalex.org/W2127837438","https://openalex.org/W2132219482","https://openalex.org/W2138660411","https://openalex.org/W2410508149","https://openalex.org/W4255191597"],"related_works":["https://openalex.org/W2114792198","https://openalex.org/W1972403965","https://openalex.org/W2978953760","https://openalex.org/W2121184314","https://openalex.org/W7095436224","https://openalex.org/W2005523188","https://openalex.org/W2052341274","https://openalex.org/W2107924210","https://openalex.org/W1975362967","https://openalex.org/W2139234402"],"abstract_inverted_index":{"Purpose:":[0],"Alosetron":[1],"is":[2],"a":[3,18,24,54],"selective":[4],"5HT3-receptor":[5],"antagonist":[6],"approved":[7],"for":[8,167],"female":[9],"patients":[10],"(pts)":[11],"with":[12,51,298,316,329,373,403,422],"severe,":[13],"chronic":[14],"diarrhea-predominant":[15],"IBS":[16,396],"under":[17,88,434],"risk":[19],"management":[20],"program":[21],"(RMP),":[22],"now":[23],"Risk":[25],"Evaluation":[26],"and":[27,45,79,84,101,127,137,151,158,181,191,194,219,225,240,263,272,338,355,370,406,418,424],"Mitigation":[28],"Strategy":[29],"(REMS)":[30],"program.":[31],"The":[32,114,213],"RMP":[33,251,348],"was":[34,119,223],"implemented":[35],"in":[36,64,95,283,289,314,327,365,395],"November":[37],"2002":[38],"following":[39],"cases":[40,123,221],"of":[41,47,61,75,97,110,124,148,189,199,216,256,267,291,294,335,352,367,393,400,432],"ischemic":[42],"colitis":[43],"(IC)":[44],"complications":[46],"constipation":[48,407],"(CoC)":[49],"associated":[50,421],"alosetron.":[52],"In":[53],"previous":[55],"publication":[56],"(Chang":[57],"L.":[58],"AJG":[59],"2010;105:866-75)":[60],"alosetron-treated":[62],"pts":[63,208,315,328],"the":[65,89,111,187,249,284,345,389,435],"clinical":[66],"practice":[67],"setting":[68],"(Nov":[69],"2002-Jun":[70],"2008),":[71],"incidence":[72],"rates":[73],"(IRs)":[74],"probable/possible":[76],"(P/P)":[77],"IC":[78,150,169,218,235,258,295,354,376,394,413,423],"CoC":[80,152,171,220,243,268,281,302,356,425],"were":[81,140,153,184,231,304,363,408],"rare":[82],"(0.95":[83],"0.36":[85],"cases/1000":[86,197,238,246,383],"pt-years)":[87],"RMP.":[90,112],"This":[91],"study":[92],"evaluates":[93],"changes":[94],"IRs":[96,180,183,290,351,366],"P/P":[98,149,168,234,257,353],"IC,":[99,125,336],"CoC,":[100,126,337,368],"other":[102],"clinically-relevant":[103],"adverse":[104],"events":[105],"(AEs)":[106],"over":[107,275,344,361],"9":[108],"yrs":[109],"Methods:":[113],"alosetron":[115,192,211,347,433],"postmarketing":[116],"safety":[117],"database":[118],"searched":[120],"to":[121,411,427],"identify":[122],"related":[128],"AEs":[129,190,399,417],"from":[130,142],"20":[131],"Nov":[132,204],"2002-31":[133],"Dec":[134],"2011.":[135],"Pt":[136],"AE":[138],"information":[139],"extracted":[141],"FDA":[143],"MedWatch":[144],"forms.":[145],"Medical":[146],"adjudication":[147],"based":[154],"on":[155],"FDA-defined":[156],"criteria":[157],"performed":[159],"independently":[160],"by":[161,279],"two":[162],"gastroenterologists":[163],"(LC,":[164],"EC).":[165],"Evidence":[166],"or":[170,301,311,324,414],"included":[172],"medical":[173],"documentation,":[174],"colonoscopy,":[175],"sigmoidoscopy\u00b1biopsy,":[176],"and/or":[177],"HCP":[178],"confirmation.":[179],"cumulative":[182,254],"calculated":[185],"using":[186],"number":[188,215],"prescriptions,":[193],"expressed":[195],"as":[196,233,242,277],"pt-years":[198],"exposure":[200],"(PYE).":[201],"Results:":[202],"From":[203],"2002-Dec":[205],"2011,":[206],"\u02dc32,000":[207],"used":[209],"341,784":[210],"prescriptions.":[212],"total":[214],"potential":[217,292],"identified":[222],"43":[224],"26,":[226],"respectively.":[227],"Of":[228],"these,":[229],"29":[230],"adjudicated":[232],"(IR:":[236,244],"1.03":[237],"PYE)":[239],"7":[241],"0.25":[245],"PYE).":[247],"Over":[248],"9-yr":[250,346],"period":[252],"(Table),":[253],"IR":[255,266,377],"has":[259,269,378],"continually":[260],"been":[261,270,379],"low":[262,271],"stable.":[264],"Cumulative":[265,332],"declined":[273],"progressively":[274],"time,":[276],"evidenced":[278],"one":[280],"case":[282],"past":[285],"five":[286],"years.":[287],"Decreases":[288],"symptoms":[293],"(abdominal":[296],"pain":[297,372,402],"hematochezia/bloody":[299,374,404],"diarrhea)":[300],"(constipation)":[303],"also":[305],"observed.":[306],"No":[307],"mesenteric":[308],"ischemia,":[309],"transfusions,":[310],"deaths":[312,325],"occurred":[313,326],"IC;":[317],"no":[318],"toxic":[319],"megacolon,":[320],"intestinal":[321],"perforations,":[322],"surgeries,":[323],"CoC.Table:":[330],"[1733]":[331],"Incidence":[333],"Rates":[334],"Related":[339],"Clinical":[340],"SymptomsConclusion:":[341],"Temporal":[342],"trends":[343],"show":[349],"that":[350],"remain":[357],"rare.":[358],"Significant":[359],"reductions":[360],"time":[362],"evident":[364],"constipation,":[369],"abdominal":[371,401],"diarrhea.":[375],"stable":[380],"at":[381],"\u02dc1.0":[382],"PYE,":[384],"suggesting":[385],"this":[386],"may":[387],"reflect":[388],"inherent":[390],"background":[391],"rate":[392],"pts.":[397],"Most":[398],"diarrhea":[405],"not":[409],"due":[410],"documented":[412],"CoC.":[415],"Clinically-relevant":[416],"serious":[419],"outcomes":[420],"appear":[426],"be":[428],"mitigated":[429],"since":[430],"reintroduction":[431],"RMP/REMS.":[436],"Disclosure:":[437],"Dr.":[438,446,454,462,470],"Lin":[439],"Chang":[440],"-":[441,449,457,465,474],"Consultant:":[442],"Prometheus":[443,451,459,467,476],"Laboratories":[444,452,460,468,477],"Inc.":[445,453,461,469,478],"Kenneth":[447],"Tong":[448],"Employee:":[450,458,466,475],"Reshma":[455],"Shringarpure":[456],"Emil":[463],"Chuang":[464],"Jean":[471],"Paul":[472],"Nicandro":[473]},"counts_by_year":[{"year":2021,"cited_by_count":1}],"updated_date":"2026-09-26T08:19:03.415552","created_date":"2019-10-10T00:00:00"}
