메뉴 건너뛰기




Volumn 19, Issue 11, 2010, Pages 1166-1171

A potential competition bias in the detection of safety signals from spontaneous reporting databases

Author keywords

Data interpretation adverse drug reaction reporting system; Datamining; Drug safety; Pharmacovigilance; Signal detection

Indexed keywords

ANTHRACYCLINE DERIVATIVE; ANTICOAGULANT AGENT; ANTICONVULSIVE AGENT; ANTITHROMBOCYTIC AGENT; ATYPICAL ANTIPSYCHOTIC AGENT; BLEOMYCIN; CALCIUM CHANNEL BLOCKING AGENT; FENOFIBRATE; FIBRINOLYTIC AGENT; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IMMUNOGLOBULIN; KETOCONAZOLE; NARCOTIC ANALGESIC AGENT; NITRIC ACID DERIVATIVE; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; SULFONAMIDE; TRIPTAN DERIVATIVE; TUBERCULOSTATIC AGENT;

EID: 78049296017     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2022     Document Type: Article
Times cited : (44)

References (34)
  • 1
    • 77949648101 scopus 로고    scopus 로고
    • First, catch your signal
    • Edwards IR, Lindquist M. First, catch your signal. Drug Saf 2010; 33(4): 257-260.
    • (2010) Drug Saf , vol.33 , Issue.4 , pp. 257-260
    • Edwards, I.R.1    Lindquist, M.2
  • 2
    • 0030497852 scopus 로고    scopus 로고
    • Regulatory pharmacovigilance in the United Kingdom: current principles and practice
    • Waller PC, Coulson RA, Wood SM. Regulatory pharmacovigilance in the United Kingdom: current principles and practice. Pharmacoepidemiol Drug Saf 1996; 5(6): 363-375.
    • (1996) Pharmacoepidemiol Drug Saf , vol.5 , Issue.6 , pp. 363-375
    • Waller, P.C.1    Coulson, R.A.2    Wood, S.M.3
  • 3
    • 14844295732 scopus 로고    scopus 로고
    • Assessing drug safety
    • Moore N. Assessing drug safety. BMJ 2005; 330(7490): 539-540.
    • (2005) BMJ , vol.330 , Issue.7490 , pp. 539-540
    • Moore, N.1
  • 4
    • 17244369520 scopus 로고    scopus 로고
    • The history of disproportionality measures (reporting odds ratio, proportional reporting rates) in spontaneous reporting of adverse drug reactions
    • Moore N, Thiessard F, Begaud B. The history of disproportionality measures (reporting odds ratio, proportional reporting rates) in spontaneous reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf 2005; 14(4): 285-286.
    • (2005) Pharmacoepidemiol Drug Saf , vol.14 , Issue.4 , pp. 285-286
    • Moore, N.1    Thiessard, F.2    Begaud, B.3
  • 5
    • 68149124572 scopus 로고    scopus 로고
    • Quantitative signal detection using spontaneous ADR reporting
    • Bate A, Evans SJ. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf 2009; 18(6): 427-436.
    • (2009) Pharmacoepidemiol Drug Saf , vol.18 , Issue.6 , pp. 427-436
    • Bate, A.1    Evans, S.J.2
  • 6
    • 0038931405 scopus 로고    scopus 로고
    • Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system
    • Dumouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat 1999; 53: 177-202.
    • (1999) Am Stat , vol.53 , pp. 177-202
    • Dumouchel, W.1
  • 7
    • 4344689546 scopus 로고    scopus 로고
    • Association of asthma therapy and Churg-Strauss syndrome: an analysis of postmarketing surveillance data
    • DuMouchel W, Smith ET, Beasley R, et al. Association of asthma therapy and Churg-Strauss syndrome: an analysis of postmarketing surveillance data. Clin Ther 2004; 26(7): 1092-1104.
    • (2004) Clin Ther , vol.26 , Issue.7 , pp. 1092-1104
    • DuMouchel, W.1    Smith, E.T.2    Beasley, R.3
  • 8
    • 0031871338 scopus 로고    scopus 로고
    • A Bayesian neural network method for adverse drug reaction signal generation
    • Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 1998; 54(4): 315-321.
    • (1998) Eur J Clin Pharmacol , vol.54 , Issue.4 , pp. 315-321
    • Bate, A.1    Lindquist, M.2    Edwards, I.R.3
  • 9
    • 0035700740 scopus 로고    scopus 로고
    • Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
    • Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001; 10(6): 483-486.
    • (2001) Pharmacoepidemiol Drug Saf , vol.10 , Issue.6 , pp. 483-486
    • Evans, S.J.1    Waller, P.C.2    Davis, S.3
  • 10
    • 0030665406 scopus 로고    scopus 로고
    • Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs: a case/non-case study in the French pharmacovigilance system database
    • Moore N, Kreft-Jais C, Haramburu F, et al. Reports of hypoglycaemia associated with the use of ACE inhibitors and other drugs: a case/non-case study in the French pharmacovigilance system database. Br J Clin Pharmacol 1997; 44(5): 513-518.
    • (1997) Br J Clin Pharmacol , vol.44 , Issue.5 , pp. 513-518
    • Moore, N.1    Kreft-Jais, C.2    Haramburu, F.3
  • 11
    • 4544368008 scopus 로고    scopus 로고
    • The reporting odds ratio and its advantages over the proportional reporting ratio
    • Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf 2004; 13(8): 519-523.
    • (2004) Pharmacoepidemiol Drug Saf , vol.13 , Issue.8 , pp. 519-523
    • Rothman, K.J.1    Lanes, S.2    Sacks, S.T.3
  • 12
    • 33749440305 scopus 로고    scopus 로고
    • Comparative performance of two quantitative safety signalling methods: implications for use in a pharmacovigilance department
    • Almenoff JS, LaCroix KK, Yuen NA, Fram D, DuMouchel W. Comparative performance of two quantitative safety signalling methods: implications for use in a pharmacovigilance department. Drug Saf 2006; 29(10): 875-887.
    • (2006) Drug Saf , vol.29 , Issue.10 , pp. 875-887
    • Almenoff, J.S.1    LaCroix, K.K.2    Yuen, N.A.3    Fram, D.4    DuMouchel, W.5
  • 13
    • 29444459131 scopus 로고    scopus 로고
    • Evaluation of statistical association measures for the automatic signal generation in pharmacovigilance
    • Roux E, Thiessard F, Fourrier A, Begaud B, Tubert-Bitter P. Evaluation of statistical association measures for the automatic signal generation in pharmacovigilance. IEEE Trans Inf Technol Biomed 2005; 9(4): 518-527.
    • (2005) IEEE Trans Inf Technol Biomed , vol.9 , Issue.4 , pp. 518-527
    • Roux, E.1    Thiessard, F.2    Fourrier, A.3    Begaud, B.4    Tubert-Bitter, P.5
  • 14
    • 0036210975 scopus 로고    scopus 로고
    • A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions
    • van Puijenbroek EP, Bate A, Leufkens HG, Lindquist M, Orre R, Egberts AC. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 2002; 11(1): 3-10.
    • (2002) Pharmacoepidemiol Drug Saf , vol.11 , Issue.1 , pp. 3-10
    • van Puijenbroek, E.P.1    Bate, A.2    Leufkens, H.G.3    Lindquist, M.4    Orre, R.5    Egberts, A.C.6
  • 15
    • 0037009914 scopus 로고    scopus 로고
    • Rates of spontaneous reporting of adverse drug reactions in France
    • Begaud B, Martin K, Haramburu F, Moore N. Rates of spontaneous reporting of adverse drug reactions in France. JAMA 2002; 288(13): 1588.
    • (2002) JAMA , vol.288 , Issue.13 , pp. 1588
    • Begaud, B.1    Martin, K.2    Haramburu, F.3    Moore, N.4
  • 16
    • 0037832552 scopus 로고    scopus 로고
    • Biases affecting the proportional reporting ratio (PPR) in spontaneous reports pharmacovigilance databases: the example of sertindole
    • Moore N, Hall G, Sturkenboom M, Mann R, Lagnaoui R, Begaud B. Biases affecting the proportional reporting ratio (PPR) in spontaneous reports pharmacovigilance databases: the example of sertindole. Pharmacoepidemiol Drug Saf 2003; 12(4): 271-281.
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , Issue.4 , pp. 271-281
    • Moore, N.1    Hall, G.2    Sturkenboom, M.3    Mann, R.4    Lagnaoui, R.5    Begaud, B.6
  • 17
    • 0004163704 scopus 로고    scopus 로고
    • Pharmacoepidemiology
    • (4th edn)., Wiley: Chichester,
    • Strom LB. Pharmacoepidemiology (4th edn). Wiley: Chichester, 2005.
    • (2005)
    • Strom, L.B.1
  • 19
    • 0031709470 scopus 로고    scopus 로고
    • Under-reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system
    • Alvarez-Requejo A, Carvajal A, Begaud B, Moride Y, Vega T, Arias LH. Under-reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol 1998; 54(6): 483-488.
    • (1998) Eur J Clin Pharmacol , vol.54 , Issue.6 , pp. 483-488
    • Alvarez-Requejo, A.1    Carvajal, A.2    Begaud, B.3    Moride, Y.4    Vega, T.5    Arias, L.H.6
  • 21
    • 65949121637 scopus 로고    scopus 로고
    • Effect of date of drug marketing on disproportionality measures in pharmacovigilance: the example of suicide with SSRIs using data from the UK MHRA
    • Pariente A, Daveluy A, Laribiere-Benard A, Miremont-Salame G, Begaud B, Moore N. Effect of date of drug marketing on disproportionality measures in pharmacovigilance: the example of suicide with SSRIs using data from the UK MHRA. Drug Saf 2009; 32(5): 441-447.
    • (2009) Drug Saf , vol.32 , Issue.5 , pp. 441-447
    • Pariente, A.1    Daveluy, A.2    Laribiere-Benard, A.3    Miremont-Salame, G.4    Begaud, B.5    Moore, N.6
  • 22
    • 34748847390 scopus 로고    scopus 로고
    • Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias
    • Pariente A, Gregoire F, Fourrier-Reglat A, Haramburu F, Moore N. Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: the notoriety bias. Drug Saf 2007; 30(10): 891-898.
    • (2007) Drug Saf , vol.30 , Issue.10 , pp. 891-898
    • Pariente, A.1    Gregoire, F.2    Fourrier-Reglat, A.3    Haramburu, F.4    Moore, N.5
  • 23
    • 0036032338 scopus 로고    scopus 로고
    • Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs
    • Bate A, Lindquist M, Orre R, Edwards IR, Meyboom RH. Data-mining analyses of pharmacovigilance signals in relation to relevant comparison drugs. Eur J Clin Pharmacol 2002; 58(7): 483-490.
    • (2002) Eur J Clin Pharmacol , vol.58 , Issue.7 , pp. 483-490
    • Bate, A.1    Lindquist, M.2    Orre, R.3    Edwards, I.R.4    Meyboom, R.H.5
  • 24
    • 0003506747 scopus 로고    scopus 로고
    • Detection of New Adverse Drug Reactions
    • (4th edn)., Macmillan Reference Ltd: London,
    • Stephens MDB, Talbot JCC, Routledge PA. Detection of New Adverse Drug Reactions (4th edn). Macmillan Reference Ltd: London, 1998.
    • (1998)
    • Stephens, M.D.B.1    Talbot, J.C.C.2    Routledge, P.A.3
  • 25
    • 0022361401 scopus 로고
    • Adverse drug reaction monitoring: doing it the French way
    • Moore N, Biour M, Paux G, et al. Adverse drug reaction monitoring: doing it the French way. Lancet 1985; 2(8463): 1056-1058.
    • (1985) Lancet , vol.2 , Issue.8463 , pp. 1056-1058
    • Moore, N.1    Biour, M.2    Paux, G.3
  • 27
    • 0141547431 scopus 로고    scopus 로고
    • Pharmacovigilance
    • (2nd edn)., Wiley: Chichester,
    • Mann R, Andrews E. Pharmacovigilance (2nd edn). Wiley: Chichester, 2006.
    • (2006)
    • Mann, R.1    Andrews, E.2
  • 28
    • 0003845352 scopus 로고    scopus 로고
    • Meyler's Side Effects of Drugs
    • (14th edn)., Elsevier: Amsterdam,
    • Dukes M, Aronson J. Meyler's Side Effects of Drugs (14th edn). Elsevier: Amsterdam, 2000.
    • (2000)
    • Dukes, M.1    Aronson, J.2
  • 29
    • 78049317345 scopus 로고    scopus 로고
    • Modern Epidemiology (2nd edn) [Database on the Internet]. Available at: [accessed on 10 September 2007].
    • Modern Epidemiology (2nd edn) [Database on the Internet]. 2007. Available at: [accessed on 10 September 2007].
    • (2007)
  • 30
    • 72449176909 scopus 로고    scopus 로고
    • Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor?
    • Trifiro G, Pariente A, Coloma PM, et al. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf 2009; 18(12): 1176-1184.
    • (2009) Pharmacoepidemiol Drug Saf , vol.18 , Issue.12 , pp. 1176-1184
    • Trifiro, G.1    Pariente, A.2    Coloma, P.M.3
  • 32
    • 0028077408 scopus 로고
    • Severe adverse cutaneous reactions to drugs
    • Roujeau JC, Stern RS. Severe adverse cutaneous reactions to drugs. N Engl J Med 1994; 331(19): 1272-1285.
    • (1994) N Engl J Med , vol.331 , Issue.19 , pp. 1272-1285
    • Roujeau, J.C.1    Stern, R.S.2
  • 33
    • 37049020666 scopus 로고    scopus 로고
    • Stevens-Johnson syndrome and toxic epidermal necrolysis: assessment of medication risks with emphasis on recently marketed drugs. The EuroSCAR-study
    • Mockenhaupt M, Viboud C, Dunant A, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: assessment of medication risks with emphasis on recently marketed drugs. The EuroSCAR-study. J Invest Dermatol 2008; 128(1): 35-44.
    • (2008) J Invest Dermatol , vol.128 , Issue.1 , pp. 35-44
    • Mockenhaupt, M.1    Viboud, C.2    Dunant, A.3
  • 34
    • 34447115729 scopus 로고    scopus 로고
    • Signal detection in the pharmaceutical industry: integrating clinical and computational approaches
    • Hauben M. Signal detection in the pharmaceutical industry: integrating clinical and computational approaches. Drug Saf 2007; 30(7): 627-630.
    • (2007) Drug Saf , vol.30 , Issue.7 , pp. 627-630
    • Hauben, M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.