{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T09:43:05Z","timestamp":1788860585702,"version":"build-2803163510"},"reference-count":58,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2013,10,5]],"date-time":"2013-10-05T00:00:00Z","timestamp":1380931200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2013,10,5]],"date-time":"2013-10-05T00:00:00Z","timestamp":1380931200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2013,12]]},"DOI":"10.1007\/s40264-013-0113-z","type":"journal-article","created":{"date-parts":[[2013,10,3]],"date-time":"2013-10-03T21:50:48Z","timestamp":1380837048000},"page":"1129-1149","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":92,"title":["Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium Guidance"],"prefix":"10.1007","volume":"36","author":[{"given":"Anjan K.","family":"Banerjee","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sally","family":"Okun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I. Ralph","family":"Edwards","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Wicks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meredith Y.","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen J.","family":"Mayall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Flamion","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Cleeland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ethan","family":"Basch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2013,10,5]]},"reference":[{"issue":"4","key":"113_CR1","doi-asserted-by":"publisher","first-page":"277","DOI":"10.1007\/s40264-013-0026-x","volume":"36","author":"E Basch","year":"2013","unstructured":"Basch E. Systematic collection of patient-reported adverse drug reactions: a path to patient-centred pharmacovigilance. Drug Saf. 2013;36(4):277\u20138.","journal-title":"Drug Saf"},{"issue":"4","key":"113_CR2","doi-asserted-by":"publisher","first-page":"267","DOI":"10.1007\/s40264-013-0028-8","volume":"36","author":"R Leone","year":"2013","unstructured":"Leone R, Moretti U, D\u2019Incau P, Conforti A, Magro L, Lora R, et al. Effect of pharmacist involvement on patient reporting of adverse drug reactions: first Italian study. Drug Saf. 2013;36(4):267\u201376.","journal-title":"Drug Saf"},{"issue":"6","key":"113_CR3","doi-asserted-by":"publisher","first-page":"437","DOI":"10.2165\/11632390-000000000-00000","volume":"35","author":"AK Banerjee","year":"2012","unstructured":"Banerjee AK, Ingate S. Web-based patient-reported outcomes in drug safety and risk management: challenges and opportunities? Drug Saf. 2012;35(6):437\u201346.","journal-title":"Drug Saf."},{"issue":"8","key":"113_CR4","doi-asserted-by":"publisher","first-page":"814","DOI":"10.1001\/jama.2013.879","volume":"309","author":"M Calvert","year":"2013","unstructured":"Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA. 2013;309(8):814\u201322.","journal-title":"JAMA."},{"issue":"1","key":"113_CR5","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1002\/bjs.8989","volume":"100","author":"RC Macefield","year":"2013","unstructured":"Macefield RC, Avery KN, Blazeby JM. Integration of clinical and patient-reported outcomes in surgical oncology. Br J Surg. 2013;100(1):28\u201337.","journal-title":"Br J Surg."},{"issue":"12","key":"113_CR6","doi-asserted-by":"publisher","first-page":"1441","DOI":"10.1111\/codi.12019","volume":"14","author":"AK Banerjee","year":"2012","unstructured":"Banerjee AK. Patient-reported outcome in colorectal health and disease. Colorectal Dis. 2012;14(12):1441\u20134.","journal-title":"Colorectal Dis."},{"issue":"12","key":"113_CR7","doi-asserted-by":"publisher","first-page":"1929","DOI":"10.1093\/annonc\/mdp287","volume":"20","author":"M Cirillo","year":"2009","unstructured":"Cirillo M, Venturini M, Ciccarelli L, Coati F, Bortolami O, Verlato G. Clinician versus nurse symptom reporting using the National Cancer Institute-Common Terminology Criteria for Adverse Events during chemotherapy: results of a comparison based on patient\u2019s self-reported questionnaire. Ann Oncol. 2009;20(12):1929\u201335.","journal-title":"Ann Oncol."},{"key":"113_CR8","unstructured":"Herxheimer A, Crombag R, Alves TL. Direct patient reporting of adverse drug reactions\u2014a fifteen-country survey & literature review. 2010. http:\/\/www.haiweb.org\/10052010\/10_May_2010_Report_Direct_Patient_Reporting_of_ADRs.pdf. Accessed 22 Aug 2013."},{"key":"113_CR9","doi-asserted-by":"crossref","unstructured":"van HF, Harmark L, Pal S, Olsson S, van GK. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012;35(1):45\u201360.","DOI":"10.2165\/11594320-000000000-00000"},{"issue":"2","key":"113_CR10","doi-asserted-by":"publisher","first-page":"492","DOI":"10.3390\/ijerph6020492","volume":"6","author":"M Swan","year":"2009","unstructured":"Swan M. Emerging patient-driven health care models: an examination of health social networks, consumer personalized medicine and quantified self-tracking. Int J Environ Res Public Health. 2009;6(2):492\u2013525.","journal-title":"Int J Environ Res Public Health."},{"key":"113_CR11","unstructured":"Chee BW, Berlin R, Schatz B. Predicting adverse drug events from personal health messages. 2013. http:\/\/www.ncbinlmnih.gov\/pmc\/articles\/PMC3243174\/. Accessed 22 Aug. 2013."},{"issue":"5","key":"113_CR12","doi-asserted-by":"publisher","first-page":"939","DOI":"10.1007\/s11136-012-0218-3","volume":"22","author":"J Greenhalgh","year":"2013","unstructured":"Greenhalgh J, Abhyankar P, McCluskey S, Takeuchi E, Velikova G. How do doctors refer to patient-reported outcome measures (PROMS) in oncology consultations? Qual Life Res. 2013;22(5):939\u201350.","journal-title":"Qual Life Res."},{"issue":"1","key":"113_CR13","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1093\/eurjhf\/hfq213","volume":"13","author":"T Eschenhagen","year":"2011","unstructured":"Eschenhagen T, Force T, Ewer MS, de Keulenaer GW, Suter TM, Anker SD, et al. Cardiovascular side effects of cancer therapies: a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2011;13(1):1\u201310.","journal-title":"Eur J Heart Fail."},{"issue":"Suppl 15","key":"113_CR14","doi-asserted-by":"crossref","first-page":"e19585","DOI":"10.1200\/jco.2010.28.15_suppl.e19585","volume":"28","author":"RA Buckman","year":"2010","unstructured":"Buckman, RA, Berman, HK, Sridhar, SS, Joshua, AM. How much do the side effects of chemotherapy matter? Patients\u2019 attitudes to side effects versus a potential loss of duration of remission. J Clin Oncol. 2010;28(Suppl 15):e19585.","journal-title":"J Clin Oncol"},{"key":"113_CR15","unstructured":"European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP) Annex I\u2014Definitions . 2012. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Template_or_form\/2013\/05\/WC500143294.pdf. Accessed 22 Sept 2013."},{"key":"113_CR16","unstructured":"U.S. Food and Drug Administration (FDA). Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. 2009. http:\/\/www.fda.gov\/downloads\/drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM193282.pdf. Accessed 23 Sept 2013."},{"key":"113_CR17","unstructured":"Committee for Medicinal Products For Human Use (CHMP). Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. 2005. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500003637.pdf. Accessed 22 Aug 2013."},{"issue":"12","key":"113_CR18","doi-asserted-by":"publisher","first-page":"1905","DOI":"10.1093\/annonc\/mdp542","volume":"20","author":"E Basch","year":"2009","unstructured":"Basch E. Patient-reported outcomes in drug safety evaluation. Ann Oncol. 2009;20(12):1905\u20136.","journal-title":"Ann Oncol."},{"issue":"24","key":"113_CR19","doi-asserted-by":"publisher","first-page":"1808","DOI":"10.1093\/jnci\/djr493","volume":"103","author":"E Basch","year":"2011","unstructured":"Basch E, Bennett A, Pietanza MC. Use of patient-reported outcomes to improve the predictive accuracy of clinician-reported adverse events. J Natl Cancer Inst. 2011;103(24):1808\u201310.","journal-title":"J Natl Cancer Inst."},{"key":"113_CR20","volume-title":"The future of drug safety: promoting and protecting the health of the public","author":"National Research Council","year":"2007","unstructured":"National Research Council. The future of drug safety: promoting and protecting the health of the public. Washington DC: The National Academies Press; 2007."},{"issue":"17","key":"113_CR21","doi-asserted-by":"publisher","first-page":"3485","DOI":"10.1200\/JCO.2004.03.025","volume":"22","author":"EK Fromme","year":"2004","unstructured":"Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004;22(17):3485\u201390.","journal-title":"J Clin Oncol."},{"issue":"5","key":"113_CR22","doi-asserted-by":"publisher","first-page":"385","DOI":"10.2165\/00002018-200629050-00003","volume":"29","author":"L Hazell","year":"2006","unstructured":"Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385\u201396.","journal-title":"Drug Saf."},{"key":"113_CR23","doi-asserted-by":"publisher","DOI":"10.1002\/9781118707999","volume-title":"Textbook of pharmacoepidemiology","author":"BL Strom","year":"2006","unstructured":"Strom BL, Kimmel SE. Textbook of pharmacoepidemiology. 1st ed. New Jersey: Wiley; 2006.","edition":"1"},{"issue":"8","key":"113_CR24","first-page":"530","volume":"14","author":"SV Pakhomov","year":"2008","unstructured":"Pakhomov SV, Jacobsen SJ, Chute CG, Roger VL. Agreement between patient-reported symptoms and their documentation in the medical record. Am J Manag Care. 2008;14(8):530\u20139.","journal-title":"Am J Manag Care."},{"issue":"2","key":"113_CR25","doi-asserted-by":"publisher","first-page":"234","DOI":"10.1001\/archinte.165.2.234","volume":"165","author":"SN Weingart","year":"2005","unstructured":"Weingart SN, Gandhi TK, Seger AC, Seger DL, Borus J, Burdick E, et al. Patient-reported medication symptoms in primary care. Arch Intern Med. 2005;165(2):234\u201340.","journal-title":"Arch Intern Med."},{"issue":"20","key":"113_CR26","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3310\/hta15200","volume":"15","author":"AJ Avery","year":"2011","unstructured":"Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, et al. Evaluation of patient reporting of adverse drug reactions to the UK \u2018Yellow Card Scheme\u2019: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):1\u2013234, iii\u2013iv.","journal-title":"Health Technol Assess"},{"key":"113_CR27","unstructured":"European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP) Module VI\u2014Management and reporting of adverse reactions to medicinal products 2012. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2012\/06\/WC500129135.pdf. Accessed 22 Aug 2013."},{"key":"113_CR28","unstructured":"National Cancer Institute. Patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). 2010. http:\/\/outcomes.cancer.gov\/tools\/pro-ctcae.html. Accessed 22 Aug 2013."},{"issue":"9755","key":"113_CR29","doi-asserted-by":"publisher","first-page":"1838","DOI":"10.1016\/S0140-6736(10)61997-6","volume":"376","author":"RT Lester","year":"2010","unstructured":"Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010;376(9755):1838\u201345.","journal-title":"Lancet."},{"issue":"24","key":"113_CR30","doi-asserted-by":"publisher","first-page":"1851","DOI":"10.1093\/jnci\/djr485","volume":"103","author":"C Quinten","year":"2011","unstructured":"Quinten C, Maringwa J, Gotay CC, Martinelli F, Coens C, Reeve BB, et al. Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst. 2011;103(24):1851\u20138.","journal-title":"J Natl Cancer Inst."},{"issue":"10","key":"113_CR31","doi-asserted-by":"publisher","first-page":"865","DOI":"10.1056\/NEJMp0911494","volume":"362","author":"E Basch","year":"2010","unstructured":"Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010;362(10):865\u20139.","journal-title":"N Engl J Med."},{"issue":"10","key":"113_CR32","doi-asserted-by":"publisher","first-page":"970","DOI":"10.1634\/theoncologist.2009-0175","volume":"14","author":"RM Goldberg","year":"2009","unstructured":"Goldberg RM, Sargent DJ, Morton RF, Green E, Sanoff HK, McLeod H, et al. NCCTG Study N9741: leveraging learning from an NCI Cooperative Group phase III trial. Oncologist. 2009;14(10):970\u20138.","journal-title":"Oncologist"},{"key":"113_CR33","unstructured":"National Quality Forum. Patient reported outcomes (PROs) workshop #1. Workshop Summary July 2012. http:\/\/www.qualityforum.org\/Projects\/n-r\/Patient-Reported_Outcomes\/Patient-Reported_Outcomes.aspx#t=2&s=&p=."},{"issue":"5","key":"113_CR34","doi-asserted-by":"publisher","first-page":"437","DOI":"10.1046\/j.1365-2648.2002.02205.x","volume":"38","author":"S Jordan","year":"2002","unstructured":"Jordan S. Managing adverse drug reactions: an orphan task. J Adv Nurs. 2002;38(5):437\u201348.","journal-title":"J Adv Nurs."},{"issue":"4","key":"113_CR35","doi-asserted-by":"publisher","first-page":"208","DOI":"10.1111\/j.1466-7657.2004.00251.x","volume":"51","author":"S Jordan","year":"2004","unstructured":"Jordan S, Knight J, Pointon D. Monitoring adverse drug reactions: scales, profiles, and checklists. Int Nurs Rev. 2004;51(4):208\u201321.","journal-title":"Int Nurs Rev."},{"key":"113_CR36","doi-asserted-by":"publisher","unstructured":"Gabe ME, Jordan SE. Development and clinical gains of nurse-led medication monitoring profiles. J Nurs Manag. 2013. doi:10.1111\/jonm.12067.","DOI":"10.1111\/jonm.12067"},{"issue":"8","key":"113_CR37","doi-asserted-by":"publisher","first-page":"2053","DOI":"10.1002\/cncr.24920","volume":"116","author":"XS Wang","year":"2010","unstructured":"Wang XS, Williams LA, Eng C, Mendoza TR, Shah NA, Kirkendoll KJ, et al. Validation and application of a module of the M. D. Anderson Symptom Inventory for Measuring Multiple Symptoms in Patients with Gastrointestinal Cancer (the MDASI-GI). Cancer. 2010;116(8):2053\u201363.","journal-title":"Cancer."},{"key":"113_CR38","first-page":"184","volume":"19","author":"T Bergvall","year":"2010","unstructured":"Bergvall T, Nilsson J, Hill R, Noren GN, Lindquist M. Assessing systematic variability in the quality of individual case safety reports. Pharmacoepidemiol Drug Saf. 2010;19:184.","journal-title":"Pharmacoepidemiol Drug Saf."},{"issue":"7","key":"113_CR39","doi-asserted-by":"publisher","first-page":"635","DOI":"10.2165\/00002018-200730070-00014","volume":"30","author":"M Lindquist","year":"2007","unstructured":"Lindquist M. Use of triage strategies in the WHO signal-detection process. Drug Saf. 2007;30(7):635\u20137.","journal-title":"Drug Saf."},{"key":"113_CR40","unstructured":"Committee for Proprietary Medicinal Products (CPMP). Points to consider on multiplicity issues in clinical trials 2010. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500003640.pdf. Accessed 22 Aug 2013."},{"key":"113_CR41","first-page":"243","volume-title":"Assessing quality of life in clinical trials","author":"D Osoba","year":"1995","unstructured":"Osoba D, King M. Meaningful differences. In: Fayers P, Hays R, editors. Assessing quality of life in clinical trials. Oxford: Oxford University Press; 1995. p. 243\u201358."},{"issue":"23","key":"113_CR42","doi-asserted-by":"publisher","first-page":"3027","DOI":"10.1001\/jama.288.23.3027","volume":"288","author":"SB Detmar","year":"2002","unstructured":"Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002;288(23):3027\u201334.","journal-title":"JAMA."},{"key":"113_CR43","first-page":"55","volume-title":"Assessing quality of life in clinical trials","author":"BB Reeve","year":"1995","unstructured":"Reeve BB, Fayers P. Applying item response theory modelling for evaluating questionnaire item and scale properties. In: Fayers P, Hays R, editors. Assessing quality of life in clinical trials. Oxford: Oxford University Press; 1995. p. 55\u201373."},{"issue":"4","key":"113_CR44","doi-asserted-by":"publisher","first-page":"407","DOI":"10.1016\/0197-2456(89)90005-6","volume":"10","author":"R Jaeschke","year":"1989","unstructured":"Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4):407\u201315.","journal-title":"Control Clin Trials."},{"issue":"3","key":"113_CR45","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1136\/amiajnl-2012-001482","volume":"20","author":"RW White","year":"2013","unstructured":"White RW, Tatonetti NP, Shah NH, Altman RB, Horvitz E. Web-scale pharmacovigilance: listening to signals from the crowd. J Am Med Inform Assoc. 2013;20(3):404\u20138.","journal-title":"J Am Med Inform Assoc."},{"key":"113_CR46","unstructured":"CIOMS. Practical aspects of signal detection in pharmacovigilance. 1st ed. Geneva: CIOMS; 2010."},{"issue":"30","key":"113_CR47","doi-asserted-by":"publisher","first-page":"4401","DOI":"10.1002\/sim.5620","volume":"31","author":"PB Ryan","year":"2012","unstructured":"Ryan PB, Madigan D, Stang PE, Overhage JM, Racoosin JA, Hartzema AG. Empirical assessment of methods for risk identification in healthcare data: results from the experiments of the Observational Medical Outcomes Partnership. Stat Med. 2012;31(30):4401\u201315.","journal-title":"Stat Med."},{"issue":"3","key":"113_CR48","doi-asserted-by":"publisher","first-page":"292","DOI":"10.1002\/pds.2051","volume":"20","author":"MJ Schuemie","year":"2011","unstructured":"Schuemie MJ. Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD. Pharmacoepidemiol Drug Saf. 2011;20(3):292\u20139.","journal-title":"Pharmacoepidemiol Drug Saf."},{"issue":"7","key":"113_CR49","doi-asserted-by":"publisher","first-page":"714","DOI":"10.1002\/pds.2151","volume":"20","author":"GN Noren","year":"2011","unstructured":"Noren GN, Hopstadius J, Bate A, Edwards IR. Safety surveillance of longitudinal databases: methodological considerations. Pharmacoepidemiol Drug Saf. 2011;20(7):714\u20137.","journal-title":"Pharmacoepidemiol Drug Saf."},{"issue":"4","key":"113_CR50","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1002\/sam.10078","volume":"3","author":"O Caster","year":"2010","unstructured":"Caster O, Noren GN, Madigan D, Bate A. Large-scale regression-based pattern discovery: the example of screening the WHO global drug safety database. Stat Anal Data Min. 2010;3(4):197\u2013208.","journal-title":"Stat Anal Data Min"},{"key":"113_CR51","doi-asserted-by":"crossref","unstructured":"Noren GN, Bate A, Hopstadius J, Star K, Edwards IR. Temporal pattern discovery for trends and transient effects: its application to patient records. In: Proceedings of the Fourteenth International Conference on Knowledge Discovery and Data Mining SIGKDD 2008. New York: ACM; 2008. p. 963\u201371.","DOI":"10.1145\/1401890.1402005"},{"issue":"4","key":"113_CR52","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1007\/s002280050466","volume":"54","author":"A Bate","year":"1998","unstructured":"Bate A, Lindquist M, Edwards IR, Olsson S, Orre R, Lansner A, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol. 1998;54(4):315\u201321.","journal-title":"Eur J Clin Pharmacol."},{"issue":"6","key":"113_CR53","doi-asserted-by":"publisher","first-page":"355","DOI":"10.1002\/pds.894","volume":"13","author":"M Stahl","year":"2004","unstructured":"Stahl M, Lindquist M, Edwards IR, Brown EG. Introducing triage logic as a new strategy for the detection of signals in the WHO Drug Monitoring Database. Pharmacoepidemiol Drug Saf. 2004;13(6):355\u201363.","journal-title":"Pharmacoepidemiol Drug Saf."},{"issue":"7296","key":"113_CR54","doi-asserted-by":"publisher","first-page":"1207","DOI":"10.1136\/bmj.322.7296.1207","volume":"322","author":"DM Coulter","year":"2001","unstructured":"Coulter DM, Bate A, Meyboom RH, Lindquist M, Edwards IR. Antipsychotic drugs and heart muscle disorder in international pharmacovigilance: data mining study. BMJ. 2001;322(7296):1207\u20139.","journal-title":"BMJ."},{"issue":"9458","key":"113_CR55","doi-asserted-by":"crossref","first-page":"482","DOI":"10.1016\/S0140-6736(05)17865-9","volume":"365","author":"EJ Sanz","year":"2005","unstructured":"Sanz EJ, De-las-Cuevas C, Kiuru A, Bate A, Edwards R. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet. 2005;365(9458):482\u20137.","journal-title":"Lancet."},{"key":"113_CR56","doi-asserted-by":"crossref","unstructured":"Noren GN. Statistical methods for knowledge discovery in adverse drug reaction surveillance. Sweden: Stockholm University; 2007.","DOI":"10.1007\/s10618-006-0052-8"},{"issue":"9","key":"113_CR57","doi-asserted-by":"publisher","first-page":"600","DOI":"10.7326\/0003-4819-153-9-201011020-00010","volume":"153","author":"PE Stang","year":"2010","unstructured":"Stang PE, Ryan PB, Racoosin JA, Overhage JM, Hartzema AG, Reich C, et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med. 2010;153(9):600\u20136.","journal-title":"Ann Intern Med."},{"issue":"7056","key":"113_CR58","doi-asserted-by":"publisher","first-page":"530","DOI":"10.1136\/bmj.313.7056.530","volume":"313","author":"TC Egberts","year":"1996","unstructured":"Egberts TC, Smulders M, de Koning FH, Meyboom RH, Leufkens HG. Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals. BMJ. 1996;313(7056):530\u20131.","journal-title":"BMJ."}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-013-0113-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40264-013-0113-z\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-013-0113-z","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-013-0113-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,12]],"date-time":"2024-08-12T07:28:11Z","timestamp":1723447691000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40264-013-0113-z"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,10,5]]},"references-count":58,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2013,12]]}},"alternative-id":["113"],"URL":"https:\/\/doi.org\/10.1007\/s40264-013-0113-z","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,10,5]]},"assertion":[{"value":"5 October 2013","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}}]}}