{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T21:50:16Z","timestamp":1789509016288,"version":"build-2803163510"},"reference-count":43,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2016,8,16]],"date-time":"2016-08-16T00:00:00Z","timestamp":1471305600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"The Danish Council for Independent research","award":["12-126864"],"award-info":[{"award-number":["12-126864"]}]}],"content-domain":{"domain":["www.plosmedicine.org"],"crossmark-restriction":false},"short-container-title":["PLoS Med"],"DOI":"10.1371\/journal.pmed.1002101","type":"journal-article","created":{"date-parts":[[2016,8,16]],"date-time":"2016-08-16T17:42:59Z","timestamp":1471369379000},"page":"e1002101","update-policy":"https:\/\/doi.org\/10.1371\/journal.pmed.corrections_policy","source":"Crossref","is-referenced-by-count":60,"title":["Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis"],"prefix":"10.1371","volume":"13","author":[{"given":"Jeppe Bennekou","family":"Schroll","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth I.","family":"Penninga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter C.","family":"G\u00f8tzsche","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2016,8,16]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"781","DOI":"10.7326\/0003-4819-141-10-200411160-00009","article-title":"Better reporting of harms in randomized trials: an extension of the CONSORT statement","volume":"141","author":"JPA Ioannidis","year":"2004","journal-title":"Ann Intern Med"},{"key":"ref2","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1186\/1472-6904-1-3","article-title":"Reporting of adverse drug reactions in randomised controlled trials\u2014a systematic survey","volume":"1","author":"YK Loke","year":"2001","journal-title":"BMC Clin Pharmacol"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1080\/080370599438266","article-title":"Adverse drug reactions in current antihypertensive therapy: a general practice survey of 2586 patients in Norway","volume":"8","author":"H Olsen","year":"1999","journal-title":"Blood Press"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"1023","DOI":"10.1136\/adc.2009.175562","article-title":"Low quality of reporting adverse drug reactions in paediatric randomised controlled trials","volume":"95","author":"TW de Vries","year":"2010","journal-title":"Arch Dis Child"},{"key":"ref5","doi-asserted-by":"crossref","first-page":"767","DOI":"10.1111\/j.1365-2125.2008.03272.x","article-title":"Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies?","volume":"66","author":"S Golder","year":"2008","journal-title":"Br J Clin Pharmacol"},{"key":"ref6","doi-asserted-by":"crossref","first-page":"782","DOI":"10.1136\/bmj.38973.444699.0B","article-title":"Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review","volume":"333","author":"AW J\u00f8rgensen","year":"2006","journal-title":"BMJ"},{"key":"ref7","unstructured":"FDA. FDA Public Health Advisory: Safety of Vioxx [Internet]. 2004. <ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm106274.htm\" xlink:type=\"simple\">http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm106274.htm<\/ext-link>"},{"key":"ref8","doi-asserted-by":"crossref","first-page":"954","DOI":"10.1001\/jama.286.8.954","article-title":"Risk of cardiovascular events associated with selective COX-2 inhibitors","volume":"286","author":"D Mukherjee","year":"2001","journal-title":"JAMA J Am Med Assoc"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"1193","DOI":"10.1056\/NEJMe068054","article-title":"Expression of concern reaffirmed","volume":"354","author":"GD Curfman","year":"2006","journal-title":"N Engl J Med"},{"key":"ref10","author":"G Harris","year":"2005"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"b3443","DOI":"10.1136\/bmj.b3443","article-title":"Research Ethics. In clear sight","volume":"339","author":"M de Andrade","year":"2009","journal-title":"BMJ"},{"key":"ref12","article-title":"Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare","author":"PC Gotzsche","year":"2013"},{"key":"ref13","doi-asserted-by":"crossref","first-page":"3850","DOI":"10.1158\/1078-0432.CCR-08-1811","article-title":"Quality of reporting of serious adverse drug events to an institutional review board: a case study with the novel cancer agent, imatinib mesylate","volume":"15","author":"DA Dorr","year":"2009","journal-title":"Clin Cancer Res Off J Am Assoc Cancer Res"},{"key":"ref14","doi-asserted-by":"crossref","first-page":"e41174","DOI":"10.1371\/journal.pone.0041174","article-title":"Challenges in coding adverse events in clinical trials: a systematic review","volume":"7","author":"JB Schroll","year":"2012","journal-title":"PLoS ONE"},{"key":"ref15","unstructured":"Structure and content of clinical study reports. E3. [Internet]. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use; 1995. <ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E3\/E3_Guideline.pdf\" xlink:type=\"simple\">http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E3\/E3_Guideline.pdf<\/ext-link>"},{"key":"ref16","doi-asserted-by":"crossref","first-page":"d2686","DOI":"10.1136\/bmj.d2686","article-title":"Opening up data at the European Medicines Agency","volume":"342","author":"PC G\u00f8tzsche","year":"2011","journal-title":"BMJ"},{"key":"ref17","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1056\/NEJM199708283370909","article-title":"Diet pills redux","volume":"337","author":"GD Curfman","year":"1997","journal-title":"N Engl J Med"},{"key":"ref18","doi-asserted-by":"crossref","first-page":"972","DOI":"10.1056\/NEJMe1007993","article-title":"Sibutramine\u2014another flawed diet pill","volume":"363","author":"GD Curfman","year":"2010","journal-title":"N Engl J Med"},{"key":"ref19","unstructured":"The European Medicines Agency recommends suspension of the marketing authorisation of Acomplia [Internet]. EMA; 2008. <ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2009\/11\/WC500014774.pdf\" xlink:type=\"simple\">http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2009\/11\/WC500014774.pdf<\/ext-link>"},{"key":"ref20","unstructured":"FDA Drug Safety Communication: Completed safety review of Xenical\/Alli (orlistat) and severe liver injury [Internet]. FDA; 2010. <ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm213038.htm\" xlink:type=\"simple\">http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm213038.htm<\/ext-link>"},{"key":"ref21","unstructured":"Roche. Clinical Study Report of Orlistat. NM14336-V219 [Internet]. 1992. <ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/figshare.com\/authors\/Jeppe_Schroll\/767386\" xlink:type=\"simple\">http:\/\/figshare.com\/authors\/Jeppe_Schroll\/767386<\/ext-link>"},{"key":"ref22","doi-asserted-by":"crossref","DOI":"10.1038\/sj.ijo.0801128","article-title":"One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor","volume":"24","author":"N Finer","year":"2000","journal-title":"Int J Obes Relat Metab Disord"},{"key":"ref23","doi-asserted-by":"crossref","first-page":"167","DOI":"10.1016\/S0140-6736(97)11509-4","article-title":"Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group","volume":"352","author":"L Sj\u00f6str\u00f6m","year":"1998","journal-title":"Lancet"},{"key":"ref24","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1038\/oby.2000.8","article-title":"Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity","volume":"8","author":"S R\u00f6ssner","year":"2000","journal-title":"Obes Res"},{"key":"ref25","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1001\/archfami.9.2.160","article-title":"Orlistat in the long-term treatment of obesity in primary care settings","volume":"9","author":"J Hauptman","year":"2000","journal-title":"Arch Fam Med"},{"key":"ref26","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1001\/jama.281.3.235","article-title":"Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial","volume":"281","author":"MH Davidson","year":"1999","journal-title":"JAMA J Am Med Assoc"},{"key":"ref27","doi-asserted-by":"crossref","first-page":"1108","DOI":"10.1093\/ajcn\/69.6.1108","article-title":"Orlistat, a lipase inhibitor, for weight maintenance after conventional dieting: a 1-y study","volume":"69","author":"JO Hill","year":"1999","journal-title":"Am J Clin Nutr"},{"key":"ref28","doi-asserted-by":"crossref","first-page":"1288","DOI":"10.2337\/diacare.21.8.1288","article-title":"Role of orlistat in the treatment of obese patients with type 2 diabetes: a 1-year randomized double-blind study","volume":"21","author":"PA Hollander","year":"1998","journal-title":"Diabetes Care"},{"issue":"Suppl 3","key":"ref29","first-page":"S24","article-title":"A one-year trial to assess the value of orlistat in the management of obesity","volume":"21","author":"WP James","year":"1997","journal-title":"Int J Obes Relat Metab Disord J Int Assoc Study Obes"},{"key":"ref30","doi-asserted-by":"crossref","first-page":"1567","DOI":"10.1038\/sj.ijo.0801443","article-title":"Effect of orlistat treatment on body composition and resting energy expenditure during a two-year weight-reduction programme in obese Finns","volume":"24","author":"L Karhunen","year":"2000","journal-title":"Int J Obes Relat Metab Disord J Int Assoc Study Obes"},{"key":"ref31","doi-asserted-by":"crossref","first-page":"2013","DOI":"10.1097\/00004872-199816121-00024","article-title":"Treatment with orlistat reduces cardiovascular risk in obese patients","volume":"16","author":"JH Zavoral","year":"1998","journal-title":"J Hypertens"},{"key":"ref32","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1177\/00912709922007543","article-title":"Long-term systemic exposure of orlistat, a lipase inhibitor, and its metabolites in obese patients","volume":"39","author":"J Zhi","year":"1999","journal-title":"J Clin Pharmacol"},{"key":"ref33","doi-asserted-by":"crossref","first-page":"1321","DOI":"10.1001\/archinte.160.9.1321","article-title":"Effects of weight loss with orlistat on glucose tolerance and progression to type 2 diabetes in obese adults","volume":"160","author":"SB Heymsfield","year":"2000","journal-title":"Arch Intern Med"},{"key":"ref34","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1038\/sj.ijo.0802165","article-title":"Predictive value of early weight loss in obesity management with orlistat: an evidence-based assessment of prescribing guidelines","volume":"27","author":"A Rissanen","year":"2003","journal-title":"Int J Obes"},{"key":"ref35","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1111\/j.1463-1326.2008.00970.x","article-title":"Orlistat 120 mg improves glycaemic control in type 2 diabetic patients with or without concurrent weight loss","volume":"11","author":"S Jacob","year":"2009","journal-title":"Diabetes Obes Metab"},{"key":"ref36","doi-asserted-by":"crossref","first-page":"827","DOI":"10.1016\/S0002-9149(00)01521-6","article-title":"Effect of orlistat-assisted weight loss in decreasing coronary heart disease risk in patients with syndrome X","volume":"87","author":"G Reaven","year":"2001","journal-title":"Am J Cardiol"},{"key":"ref37","doi-asserted-by":"crossref","first-page":"485","DOI":"10.1159\/000341589","article-title":"An Integrated Analysis of Liver Safety Data from Orlistat Clinical Trials","volume":"5","author":"M Morris","year":"2012","journal-title":"Obes Facts"},{"key":"ref38","unstructured":"Roche. Clinical Study Report of Orlistat. BM 14119B v-238 [Internet]. 1992. <ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/figshare.com\/authors\/Jeppe_Schroll\/767386\" xlink:type=\"simple\">http:\/\/figshare.com\/authors\/Jeppe_Schroll\/767386<\/ext-link>"},{"key":"ref39","unstructured":"Roche. Clinical Study Report of Orlistat. NM14336-V220 [Internet]. 1992. <ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/figshare.com\/authors\/Jeppe_Schroll\/767386\" xlink:type=\"simple\">http:\/\/figshare.com\/authors\/Jeppe_Schroll\/767386<\/ext-link>"},{"key":"ref40","doi-asserted-by":"crossref","first-page":"1567","DOI":"10.1038\/sj.ijo.0803631","article-title":"Long-term persistence with orlistat and sibutramine in a population-based cohort","volume":"31","author":"R Padwal","year":"2005","journal-title":"Int J Obes"},{"key":"ref41","doi-asserted-by":"crossref","first-page":"e002496","DOI":"10.1136\/bmjopen-2012-002496","article-title":"Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports","volume":"3","author":"P Doshi","year":"2013","journal-title":"BMJ Open"},{"key":"ref42","doi-asserted-by":"crossref","first-page":"g3510","DOI":"10.1136\/bmj.g3510","article-title":"Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications","volume":"348","author":"E Maund","year":"2014","journal-title":"BMJ"},{"key":"ref43","doi-asserted-by":"crossref","first-page":"e1001526","DOI":"10.1371\/journal.pmed.1001526","article-title":"Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data","volume":"10","author":"B Wieseler","year":"2013","journal-title":"PLoS Med"}],"container-title":["PLOS Medicine"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/dx.plos.org\/10.1371\/journal.pmed.1002101","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,9]],"date-time":"2020-05-09T06:28:37Z","timestamp":1589005717000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pmed.1002101"}},"subtitle":[],"editor":[{"given":"Adriane","family":"Fugh-Berman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2016,8,16]]},"references-count":43,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2016,8,16]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pmed.1002101","relation":{},"ISSN":["1549-1676"],"issn-type":[{"value":"1549-1676","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,8,16]]}}}