-
1
-
-
84859807204
-
-
US Food and Drug Administration. Department of Health and Human Services [online] [Accessed 2009 Dec 23]
-
US Food and Drug Administration, Department of Health and Human Services. FDAAA Law [online]. Available from URL: http://frwebgate.access.gpo.gov/cgi- bin/getdoc. cgi?dbname=110-cong-public-laws&docid=f:publ085.110 [Accessed 2009 Dec 23]
-
FDAAA Law
-
-
-
2
-
-
72449176909
-
Data mining on electronic health record databases for signal detection in pharmacovigilance: Which events to monitor? Pharmacoepidemiol
-
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: 1176-84
-
(2009)
Drug Saf
, vol.18
, pp. 1176-1184
-
-
Trifiro, G.1
Pariente, A.2
Coloma, P.M.3
-
3
-
-
18044398603
-
A review of uses of health care utilization databases for epidemiologic research on therapeutics
-
Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics. J Clin Epidemiol 2005; 58: 323-37
-
(2005)
J Clin Epidemiol
, vol.58
, pp. 323-337
-
-
Schneeweiss, S.1
Avorn, J.2
-
4
-
-
36549040492
-
In defense of pharmacoepidemiology: Embracing the yin and yang of drug research
-
Avorn J. In defense of pharmacoepidemiology: embracing the yin and yang of drug research. N Engl J Med 2007; 357: 2219-21
-
(2007)
N Engl J Med
, vol.357
, pp. 2219-2221
-
-
Avorn, J.1
-
5
-
-
68849085448
-
The new Sentinel Network: Improving the evidence of medical-product safety
-
Platt R, Wilson M, Chan KA, et al. The new Sentinel Network: improving the evidence of medical-product safety. N Engl J Med 2009; 361: 645-7
-
(2009)
N Engl J Med
, vol.361
, pp. 645-647
-
-
Platt, R.1
Wilson, M.2
Chan, K.A.3
-
6
-
-
59649130396
-
Active drug safety surveillance: A tool to improve public health
-
Platt R, Madre L, Reynolds R, et al. Active drug safety surveillance: a tool to improve public health. Pharmacoepidemiol Drug Saf 2008; 17: 1175-82
-
(2008)
Pharmacoepidemiol Drug Saf
, vol.17
, pp. 1175-1182
-
-
Platt, R.1
Madre, L.2
Reynolds, R.3
-
7
-
-
73349110088
-
Active influenza vaccine safety surveillance: Potential within a healthcare claims environment
-
Brown JS, Moore KM, Braun MM, et al. Active influenza vaccine safety surveillance: potential within a healthcare claims environment. Med Care 2009; 47: 1251-7
-
(2009)
Med Care
, vol.47
, pp. 1251-1257
-
-
Brown, J.S.1
Moore, K.M.2
Braun, M.M.3
-
8
-
-
37349104178
-
Early detection of adverse drug events within population-based health networks: Application of sequential testing methods
-
Brown JS, Kulldorff M, Chan A, et al. Early detection of adverse drug events within population-based health networks: application of sequential testing methods. Pharmacoepidemiol Drug Saf 2007; 16: 1275-84
-
(2007)
Pharmacoepidemiol Drug Saf
, vol.16
, pp. 1275-1284
-
-
Brown, J.S.1
Kulldorff, M.2
Chan, A.3
-
9
-
-
67649304917
-
Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide
-
Dore DD, Seeger JD, Chan KA. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin 2009; 25: 1019-27
-
(2009)
Curr Med Res Opin
, vol.25
, pp. 1019-1027
-
-
Dore, D.D.1
Seeger, J.D.2
Chan, K.A.3
-
10
-
-
79851472033
-
Developing the sentinel system: A national resource for evidence development
-
Behrman RE, Benner JS, Brown JS, et al. Developing the sentinel system: a national resource for evidence development. N Engl J Med 2011; 364 (6): 498-9
-
(2011)
N Engl J Med
, vol.364
, Issue.6
, pp. 498-499
-
-
Behrman, R.E.1
Benner, J.S.2
Brown, J.S.3
-
11
-
-
78751688048
-
Advancing the science for active surveillance: Rationale and design for the Observational Medical Outcomes Partnership
-
Stang PE, Ryan PB, Racoosin JA, et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 2010; 153 (9): 600-6
-
(2010)
Ann Intern Med
, vol.153
, Issue.9
, pp. 600-606
-
-
Stang, P.E.1
Ryan, P.B.2
Racoosin, J.A.3
-
12
-
-
13744265417
-
Use of selective serotonin reuptake inhibitors and risk of upper gastrointestinal bleeding: A population-based cohort study
-
Dalton SO, Johansen C, Mellemkjaer L, et al. Use of selective serotonin reuptake inhibitors and risk of upper gastrointestinal bleeding: a population-based cohort study. Arch Intern Med 2003; 163: 59-64
-
(2003)
Arch Intern Med
, vol.163
, pp. 59-64
-
-
Dalton, S.O.1
Johansen, C.2
Mellemkjaer, L.3
-
13
-
-
0033598594
-
Association between selective serotonin reuptake inhibitors and upper gastrointestinal bleeding: Population based case-control study
-
deAbajo FJ, Rodriguez LAG, Montero D. Association between selective serotonin reuptake inhibitors and upper gastrointestinal bleeding: population based case-control study. BMJ 1999; 319: 1106-9
-
(1999)
BMJ
, vol.319
, pp. 1106-1109
-
-
Deabajo, F.J.1
Lag, R.2
Montero, D.3
-
15
-
-
0034690729
-
Association between SSRIs and upper gastrointestinal bleeding: SSRIs are no more likely than other drugs to cause such bleeding
-
Dunn NR, Pearce GL, Shakir SAW. Association between SSRIs and upper gastrointestinal bleeding: SSRIs are no more likely than other drugs to cause such bleeding. BMJ 2000; 320: 1405-6
-
(2000)
BMJ
, vol.320
, pp. 1405-1406
-
-
Dunn, N.R.1
Pearce, G.L.2
Shakir, S.A.W.3
-
16
-
-
0035026947
-
Is there an association between selective serotonin reuptake inhibitors and risk of abnormal bleeding? Results from a cohort study based on prescription event monitoring in England
-
Layton D, Clark DWJ, Pearce GL, et al. Is there an association between selective serotonin reuptake inhibitors and risk of abnormal bleeding? Results from a cohort study based on prescription event monitoring in England. Eur J Clin Pharmacol 2001; 57: 167-76
-
(2001)
Eur J Clin Pharmacol
, vol.57
, pp. 167-176
-
-
Layton, D.1
Dwj, C.2
Pearce, G.L.3
-
17
-
-
42149135488
-
Moderate and high affinity serotonin reuptake inhibitors increase the risk of upper gastrointestinal toxicity
-
Lewis JD, Strom BL, Localio AR, et al. Moderate and high affinity serotonin reuptake inhibitors increase the risk of upper gastrointestinal toxicity. Pharmacoepidemiol Drug Saf 2008; 17: 328-35
-
(2008)
Pharmacoepidemiol Drug Saf
, vol.17
, pp. 328-335
-
-
Lewis, J.D.1
Strom, B.L.2
Localio, A.R.3
-
18
-
-
8844233380
-
Association of risk of abnormal bleeding with degree of serotonin reuptake inhibition by antidepressants
-
Meijer WEE, Heerdink ER, Nolen WA, et al. Association of risk of abnormal bleeding with degree of serotonin reuptake inhibition by antidepressants. Arch Intern Med 2004; 164: 2367-70
-
(2004)
Arch Intern Med
, vol.164
, pp. 2367-2370
-
-
Wee, M.1
Heerdink, E.R.2
Nolen, W.A.3
-
19
-
-
23844510204
-
Does concurrent prescription of selective serotonin reuptake inhibitors and non-steroidal anti-inflammatory drugs substantially increase the risk of upper gastrointestinal bleeding?
-
Tata LJ, Fortun PJ, Hubbard RB, et al. Does concurrent prescription of selective serotonin reuptake inhibitors and non-steroidal anti-inflammatory drugs substantially increase the risk of upper gastrointestinal bleeding? Aliment Pharmacol Ther 2005; 22: 175-81
-
(2005)
Aliment Pharmacol Ther
, vol.22
, pp. 175-181
-
-
Tata, L.J.1
Fortun, P.J.2
Hubbard, R.B.3
-
20
-
-
0035934609
-
Inhibition of serotonin reuptake by antidepressants and upper gastrointestinal bleeding in elderly patients: Retrospective cohort study
-
van Walraven C, Mamdani MM, Wells PS, et al. Inhibition of serotonin reuptake by antidepressants and upper gastrointestinal bleeding in elderly patients: retrospective cohort study. BMJ 2001; 323: 655-8
-
(2001)
BMJ
, vol.323
, pp. 655-658
-
-
Van Walraven, C.1
Mamdani, M.M.2
Wells, P.S.3
-
21
-
-
38549178876
-
Risk of upper gastrointestinal bleeding and the degree of serotonin reuptake inhibition by antidepressants: A case-control study
-
Vidal X, Ibanez L, Vendrell L, et al. Risk of upper gastrointestinal bleeding and the degree of serotonin reuptake inhibition by antidepressants: a case-control study. Drug Saf 2008; 31: 159-68
-
(2008)
Drug Saf
, vol.31
, pp. 159-168
-
-
Vidal, X.1
Ibanez, L.2
Vendrell, L.3
-
22
-
-
33645046396
-
Increased use of selective serotonin reuptake inhibitors in patients admitted with gastrointestinal haemorrhage: A multicenter retrospective analysis
-
Wessinger S, Kaplan M, Choi L, et al. Increased use of selective serotonin reuptake inhibitors in patients admitted with gastrointestinal haemorrhage: a multicenter retrospective analysis. Aliment Pharmacol Ther 2006; 23: 937-44
-
(2006)
Aliment Pharmacol Ther
, vol.23
, pp. 937-944
-
-
Wessinger, S.1
Kaplan, M.2
Choi, L.3
-
23
-
-
77953517347
-
Validation of claims-based diagnostic and procedure codes for cardiovascular and gastrointestinal serious adverse events in a commercially-insured population
-
Wahl PM, Rodgers K, Schneeweiss S, et al. Validation of claims-based diagnostic and procedure codes for cardiovascular and gastrointestinal serious adverse events in a commercially-insured population. Pharmaceopidemiol and Drug Saf 2010; 19 (6): 596-603
-
(2010)
Pharmaceopidemiol and Drug Saf
, vol.19
, Issue.6
, pp. 596-603
-
-
Wahl, P.M.1
Rodgers, K.2
Schneeweiss, S.3
-
24
-
-
0030064245
-
Positive predictive value of ICD-9 codes in the identification of cases of complicated peptic ulcer disease in the Saskatchewan hospital automated database
-
Raiford DS, Perez Gutthann S, Garcia Rodriguez LA. Positive predictive value of ICD-9 codes in the identification of cases of complicated peptic ulcer disease in the Saskatchewan hospital automated database. Epidemiology 1996; 7: 101-4
-
(1996)
Epidemiology
, vol.7
, pp. 101-104
-
-
Raiford, D.S.1
Perez Gutthann, S.2
Garcia Rodriguez, L.A.3
-
25
-
-
0036184165
-
Validation of diagnoses of peptic ulcers and bleeding from administrative databases: A multi-health maintenance organization study
-
Andrade SE, Gurwitz JH, Chan KA, et al. Validation of diagnoses of peptic ulcers and bleeding from administrative databases: a multi-health maintenance organization study. J Clin Epidemiol 2002; 55: 310-3
-
(2002)
J Clin Epidemiol
, vol.55
, pp. 310-313
-
-
Andrade, S.E.1
Gurwitz, J.H.2
Chan, K.A.3
-
26
-
-
0031804758
-
Angioedema due to ACE inhibitors: Common and inadequately diagnosed
-
Angioedema due to ACE inhibitors: common and inadequately diagnosed. Prescrire Int 1998; 7 (35): 92-3
-
(1998)
Prescrire Int
, vol.7
, Issue.35
, pp. 92-93
-
-
-
27
-
-
33747382766
-
Clinical events in high-risk hypertensive patients randomly assigned to calcium channel blocker versus angiotensin-converting enzyme inhibitor in the antihypertensive and lipid-lowering treatment to prevent heart attack trial
-
Leenen FH, Nwachuku CE, Black HR, et al. Clinical events in high-risk hypertensive patients randomly assigned to calcium channel blocker versus angiotensin-converting enzyme inhibitor in the antihypertensive and lipid-lowering treatment to prevent heart attack trial. Hypertension 2006; 48 (3): 374-84
-
(2006)
Hypertension
, vol.48
, Issue.3
, pp. 374-384
-
-
Leenen, F.H.1
Nwachuku, C.E.2
Black, H.R.3
-
28
-
-
34548514428
-
Incidence and predictors of angioedema in elderly hypertensive patients at high risk for cardiovascular disease: A report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
-
Piller LB, Ford CE, Davis BR, et al. Incidence and predictors of angioedema in elderly hypertensive patients at high risk for cardiovascular disease: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens (Greenwich) 2006; 8 (9): 649-56
-
(2006)
J Clin Hypertens (Greenwich)
, vol.8
, Issue.9
, pp. 649-656
-
-
Piller, L.B.1
Ford, C.E.2
Davis, B.R.3
-
29
-
-
0031937154
-
ACE inhibitor-induced angioedema: Incidence, prevention and management
-
Vleeming W, van Amsterdam JG, Stricker BH, et al. ACE inhibitor-induced angioedema: incidence, prevention and management. Drug Saf 1998; 18 (3): 171-88
-
(1998)
Drug Saf
, vol.18
, Issue.3
, pp. 171-188
-
-
Vleeming, W.1
Van Amsterdam, J.G.2
Stricker, B.H.3
-
30
-
-
33749429683
-
Achilles tendon rupture and its association with fluoroquinolone antibiotics and other potential risk factors in a managed care population
-
Seeger JD, West WA, Fife D, et al. Achilles tendon rupture and its association with fluoroquinolone antibiotics and other potential risk factors in a managed care population. Pharmacoepidemiol Drug Saf 2006; 15 (11): 784-92
-
(2006)
Pharmacoepidemiol Drug Saf
, vol.15
, Issue.11
, pp. 784-792
-
-
Seeger, J.D.1
West, W.A.2
Fife, D.3
-
31
-
-
33749439348
-
Evidence of tendinitis provoked by fluoroquinolone treatment: A case-control study
-
Corrao G, Zambon A, Bertu L, et al. Evidence of tendinitis provoked by fluoroquinolone treatment: a case-control study. Drug Saf 2006; 29 (10): 889-96
-
(2006)
Drug Saf
, vol.29
, Issue.10
, pp. 889-896
-
-
Corrao, G.1
Zambon, A.2
Bertu, L.3
-
32
-
-
34147129729
-
Use of fluroquinolone and risk of Achilles tendon rupture: A population-based cohort study
-
Sode J, Obel N, Hallas J, et al. Use of fluroquinolone and risk of Achilles tendon rupture: a population-based cohort study. Eur J Clin Pharmacol 2007; 63 (5): 499-503
-
(2007)
Eur J Clin Pharmacol
, vol.63
, Issue.5
, pp. 499-503
-
-
Sode, J.1
Obel, N.2
Hallas, J.3
-
34
-
-
0036606890
-
Fluoroquinolones and risk of Achilles tendon disorders: Case-control study
-
Van der Linden PD, Sturkenboom MC, Herings RM, et al. Fluoroquinolones and risk of Achilles tendon disorders: case-control study. BMJ 2002; 324 (7349): 1306-7
-
(2002)
BMJ
, vol.324
, Issue.7349
, pp. 1306-1307
-
-
Van Der Linden, P.D.1
Sturkenboom, M.C.2
Herings, R.M.3
-
35
-
-
0041653426
-
Increased risk of achilles tendon rupture with quinolone antibacterial use, especially in elderly patients taking oral corticosteroids
-
Van der Linden PD, Sturkenboom MC, Herings RM, et al. Increased risk of achilles tendon rupture with quinolone antibacterial use, especially in elderly patients taking oral corticosteroids. Arch Intern Med 2003; 163 (15): 1801-7
-
(2003)
Arch Intern Med
, vol.163
, Issue.15
, pp. 1801-1807
-
-
Van Der Linden, P.D.1
Sturkenboom, M.C.2
Herings, R.M.3
-
36
-
-
0035990390
-
Tendon or joint disorders in children after treatment with fluoroquinolones or azithromycin
-
Yee CL, Duffy C, Gerbino PG, et al. Tendon or joint disorders in children after treatment with fluoroquinolones or azithromycin. Pediatr Infect Dis J 2002; 21 (6): 525-9
-
(2002)
Pediatr Infect Dis J
, vol.21
, Issue.6
, pp. 525-529
-
-
Yee, C.L.1
Duffy, C.2
Gerbino, P.G.3
-
37
-
-
0003262670
-
Reducing bias in a propensity score matchedpair sample using greedy matching techniques
-
Apr 22-25; SAS Institute Inc, Cary (NC)
-
Parsons LS. Reducing bias in a propensity score matchedpair sample using greedy matching techniques. Proceedings of the Twenty-Sixth Annual SAS Users Group International Conference. 2001 Apr 22-25; SAS Institute Inc, Cary (NC)
-
(2001)
Proceedings of the Twenty-Sixth Annual SAS Users Group International Conference
-
-
Parsons, L.S.1
-
38
-
-
74749106619
-
A conditional maximized sequential probability ratio test for pharmacovigilance
-
Li L, Kulldorff M. A conditional maximized sequential probability ratio test for pharmacovigilance. Stat Med 2010; 29 (2): 284-95
-
(2010)
Stat Med
, vol.29
, Issue.2
, pp. 284-295
-
-
Li, L.1
Kulldorff, M.2
-
39
-
-
65249168893
-
Early adverse drug event signal detection within population-based health networks using sequential methods: Key methodologic considerations
-
Brown JS, Kulldorff M, Petronis KR, et al. Early adverse drug event signal detection within population-based health networks using sequential methods: key methodologic considerations. Pharmacoepidemiol Drug Saf, 2009; 18: 226-34
-
(2009)
Pharmacoepidemiol Drug Saf
, vol.18
, pp. 226-234
-
-
Brown, J.S.1
Kulldorff, M.2
Petronis, K.R.3
-
40
-
-
34848826898
-
Real-time vaccine safety surveillance for the early detection of adverse events
-
Lieu TA, Kulldorff M, Davis RL, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care 2007; 45 (10 Suppl. 2): S89-95
-
(2007)
Med Care
, vol.45
, Issue.10 SUPPL. 2
-
-
Lieu, T.A.1
Kulldorff, M.2
Davis, R.L.3
-
41
-
-
0035700740
-
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): 483-6
-
(2001)
Pharmacoepidemiol Drug Saf
, vol.10
, Issue.6
, pp. 483-486
-
-
Evans, S.J.1
Waller, P.C.2
Davis, S.3
-
43
-
-
78751631255
-
A maximized sequential probability ratio test for drug and vaccine safety surveillance
-
Kulldorff M, Davis RL, Kolczak M, et al. A maximized sequential probability ratio test for drug and vaccine safety surveillance. Seq Anal 2011; 30 (1): 58-78
-
(2011)
Seq Anal
, vol.30
, Issue.1
, pp. 58-78
-
-
Kulldorff, M.1
Davis, R.L.2
Kolczak, M.3
-
44
-
-
78149345321
-
Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices
-
Resnic FS, Gross TP, Marinac-Dabic D, et al. Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices. JAMA 2010; 304 (18): 2019-27
-
(2010)
JAMA
, vol.304
, Issue.18
, pp. 2019-2027
-
-
Resnic, F.S.1
Gross, T.P.2
Marinac-Dabic, D.3
-
46
-
-
81355127388
-
Temporal pattern discovery in longitudinal electronic patient records
-
Noren GN, Hopstadius J, Bate A, et al. Temporal pattern discovery in longitudinal electronic patient records. Data Min Knowl Discov 2010; 20 (3): 361-87
-
(2010)
Data Min Knowl Discov
, vol.20
, Issue.3
, pp. 361-387
-
-
Noren, G.N.1
Hopstadius, J.2
Bate, A.3
-
47
-
-
79951975416
-
Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD
-
Schuemie MJ. Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD. Pharmacoepidemiol Drug Saf 2011; 20: 292-9
-
(2011)
Pharmacoepidemiol Drug Saf
, vol.20
, pp. 292-299
-
-
Schuemie, M.J.1
-
48
-
-
78650457394
-
Development and evaluation of a common data model enabling active drug safety surveillance using disparate healthcare databases
-
Nov-Dec
-
Reisinger SJ, Ryan PB, OHara DJ, et al. Development and evaluation of a common data model enabling active drug safety surveillance using disparate healthcare databases. J Am Med Inform Assoc 2010 Nov-Dec;17 (6): 652-62
-
(2010)
J Am Med Inform Assoc
, vol.17
, Issue.6
, pp. 652-662
-
-
Reisinger, S.J.1
Ryan, P.B.2
Ohara, D.J.3
-
49
-
-
84859874348
-
Electronic healthcare databases for active drug safety surveillance: Is there enough leverage?
-
on behalf of the EU-ADR consortium Epub Feb 8
-
Coloma PM, Trifirò G, Schuemie MJ, et al., on behalf of the EU-ADR consortium. Electronic healthcare databases for active drug safety surveillance: is there enough leverage? Pharmacoepidemiol Drug Saf. Epub 2012 Feb 8
-
(2012)
Pharmacoepidemiol Drug Saf.
-
-
Coloma, P.M.1
Trifirò, G.2
Schuemie, M.J.3
-
50
-
-
0347447334
-
A propensity score-matched cohort study of the effect of statins, mainly fluvastatin, on the occurrence of acute myocardial infarction
-
Seeger JD, Walker AM, Williams PL, et al. A propensity score-matched cohort study of the effect of statins, mainly fluvastatin, on the occurrence of acute myocardial infarction. Am J Cardiol 2003; 92 (12): 1447-51
-
(2003)
Am J Cardiol
, vol.92
, Issue.12
, pp. 1447-1451
-
-
Seeger, J.D.1
Walker, A.M.2
Williams, P.L.3
|