{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T14:53:10Z","timestamp":1786632790352,"version":"build-2736575974"},"reference-count":43,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,12,23]],"date-time":"2015-12-23T00:00:00Z","timestamp":1450828800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2015,12,23]],"date-time":"2015-12-23T00:00:00Z","timestamp":1450828800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie Inc","doi-asserted-by":"crossref","award":["NCT00357994\/NCT00660387"],"award-info":[{"award-number":["NCT00357994\/NCT00660387"]}],"id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100006483","name":"AbbVie Inc","doi-asserted-by":"crossref","award":["NCT00335153"],"award-info":[{"award-number":["NCT00335153"]}],"id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100006483","name":"AbbVie Inc","doi-asserted-by":"crossref","award":["NCT00660673"],"award-info":[{"award-number":["NCT00660673"]}],"id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100006483","name":"AbbVie Inc","doi-asserted-by":"crossref","award":["NCT00360568"],"award-info":[{"award-number":["NCT00360568"]}],"id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Movement Disorders"],"published-print":{"date-parts":[[2016,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Continuous administration of levodopa\u2010carbidopa intestinal gel (carbidopa\u2010levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Safety data from 4 studies were summarized using 2 overlapping data sets, permitting the separation of procedure\/device\u2013associated (n\u2009=\u2009395) from non\u2010procedure\/device adverse events (n\u2009=\u2009412).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At the data cutoff, median exposure to levodopa\u2010carbidopa intestinal gel was 911 days (range, 1\u20101980 days) with 963 total patient\u2010years of exposure. Procedure\/device adverse events occurred in 300 patients (76%), and serious adverse events occurred in 68 (17%); most frequently reported procedure\/device adverse events and serious adverse events were complications of device insertion (41% and 8%, respectively) and abdominal pain (36% and 4%, respectively). Non\u2010procedure\/device adverse events occurred in 92% (379), with most frequently reported being insomnia (23%) and falls (23%); 42% (171) had non\u2010procedure\/device serious adverse events, with most frequently reported being pneumonia (5%) and PD symptoms (2%). Adverse events led to discontinuation in 17% (72), most frequently because of complication of device insertion (2.4%). There were 34 treatment\u2010emergent deaths (8.3%) in the overlapping data sets, 2 of which (0.5%) were considered \u201cpossibly related\u201d to the treatment system.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In the largest collection of levodopa\u2010carbidopa intestinal gel safety data from prospective clinical studies, procedure\/device events were frequently reported and occasionally life threatening. Most non\u2010procedure\/device events were typical for levodopa treatment and an elderly population. These factors combined with high treatment efficacy led to a relatively low discontinuation rate in advanced PD patients. \u00a9 2015 International Parkinson and Movement Disorder Society<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/mds.26485","type":"journal-article","created":{"date-parts":[[2015,12,23]],"date-time":"2015-12-23T05:54:42Z","timestamp":1450850082000},"page":"538-546","source":"Crossref","is-referenced-by-count":93,"title":["Integrated safety of levodopa\u2010carbidopa intestinal gel from prospective clinical trials"],"prefix":"10.1002","volume":"31","author":[{"given":"Anthony E.","family":"Lang","sequence":"first","affiliation":[{"name":"Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson's Disease, Toronto Western Hospital and Division of Neurology, UHN, Division of Neurology University of Toronto Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramon L.","family":"Rodriguez","sequence":"additional","affiliation":[{"name":"University of Florida College of Medicine Gainesville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James T.","family":"Boyd","sequence":"additional","affiliation":[{"name":"University of Vermont College of Medicine Burlington Vermont USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvain","family":"Chouinard","sequence":"additional","affiliation":[{"name":"University of Montreal Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Zadikoff","sequence":"additional","affiliation":[{"name":"Feinberg School of Medicine Northwestern University Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto J.","family":"Espay","sequence":"additional","affiliation":[{"name":"University of Cincinnati Academic Health Center Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John T.","family":"Slevin","sequence":"additional","affiliation":[{"name":"University of Kentucky Medical Center Lexington Kentucky USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hubert H.","family":"Fernandez","sequence":"additional","affiliation":[{"name":"Center for Neurological Restoration, Cleveland Clinic Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark F.","family":"Lew","sequence":"additional","affiliation":[{"name":"Keck\/University of Southern California School of Medicine Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Stein","sequence":"additional","affiliation":[{"name":"Quintiles San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Per","family":"Odin","sequence":"additional","affiliation":[{"name":"Klinikim\u2010Bremerhaven Germany and Skane University Hospital Lund Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor S.C.","family":"Fung","sequence":"additional","affiliation":[{"name":"Westmead Hospital and Sydney Medical School Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabian","family":"Klostermann","sequence":"additional","affiliation":[{"name":"Charit\u00e9\u2010University Medicine Berlin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfonso","family":"Fasano","sequence":"additional","affiliation":[{"name":"Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. 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