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Safety profile of non-vitamin K oral anticoagulants (NOACs) from a patient perspective: a web-based cohort event monitoring study.

Rolfes L, Ekhart C, Hendriks J, van der Horst P, van Puijenbroek E.

Expert Opin Drug Saf. 2019 Jul 16. doi: 10.1080/14740338.2019.1645120. [Epub ahead of print]


Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.

Denig P, van Puijenbroek EP, Soliman N, Mol PGM, de Vries ST.

Pharmacoepidemiol Drug Saf. 2019 Jun 17. doi: 10.1002/pds.4839. [Epub ahead of print]


Time to onset in statistical signal detection revisited: A follow-up study in long-term onset adverse drug reactions.

Scholl JHG, van Hunsel FPAM, Hak E, van Puijenbroek EP.

Pharmacoepidemiol Drug Saf. 2019 Jun 12. doi: 10.1002/pds.4790. [Epub ahead of print]


Drug-induced interstitial lung disease: role of pharmacogenetics in predicting cytotoxic mechanisms and risks of side effects.

Jessurun NT, Drent M, van Puijenbroek EP, Bekers O, Wijnen PA, Bast A.

Curr Opin Pulm Med. 2019 May 6. doi: 10.1097/MCP.0000000000000590. [Epub ahead of print]


Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study.

de Vries ST, Denig P, Ekhart C, Burgers JS, Kleefstra N, Mol PGM, van Puijenbroek EP.

Br J Clin Pharmacol. 2019 Jul;85(7):1507-1515. doi: 10.1111/bcp.13923. Epub 2019 Apr 29.


Anaphylactic Reaction to Tc-99m Macrosalb.

Schreuder N, de Hoog Q, van der Bruggen W, van Puijenbroek EP.

Drug Saf Case Rep. 2019 Mar 5;6(1):4. doi: 10.1007/s40800-019-0097-4.


Assessment of medication use during pregnancy by Web-based questionnaires, pharmacy records and serum screening.

van Gelder MMHJ, de Jong LAA, Te Winkel B, Olyslager EJH, Vorstenbosch S, van Puijenbroek EP, Verbeek ALM, Roeleveld N.

Reprod Toxicol. 2019 Mar;84:93-97. doi: 10.1016/j.reprotox.2019.01.002. Epub 2019 Jan 4.


Workshop on the Italian Pharmacovigilance System in the International Context: Critical Issues and Perspectives.

Sultana J, Moretti U, Addis A, Caduff P, Capuano A, Kant A, Laporte JR, Lindquist M, Raine J, Sartori D, Trifirò G, Tuccori M, Venegoni M, van Puijenbroek E, Leone R.

Drug Saf. 2019 May;42(5):683-687. doi: 10.1007/s40264-018-0768-6. No abstract available.


High-affinity CD16-polymorphism and Fc-engineered antibodies enable activity of CD16-chimeric antigen receptor-modified T cells for cancer therapy.

Rataj F, Jacobi SJ, Stoiber S, Asang F, Ogonek J, Tokarew N, Cadilha BL, van Puijenbroek E, Heise C, Duewell P, Endres S, Klein C, Kobold S.

Br J Cancer. 2019 Jan;120(1):79-87. doi: 10.1038/s41416-018-0341-1. Epub 2018 Nov 15.


Aim and Design of pREGnant, the Dutch Pregnancy Drug Register.

Vorstenbosch S, Te Winkel B, van Gelder MMHJ, Kant A, Roeleveld N, van Puijenbroek E.

Drug Saf. 2019 Jan;42(1):1-12. doi: 10.1007/s40264-018-0722-7.


A tailor-made approach for causality assessment for ADR reports on drugs and vaccines.

Oosterhuis I, Zweers P, Rümke H, Muller-Hansma A, van Puijenbroek EP.

Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):544-550. doi: 10.1002/pds.4637. Epub 2018 Aug 30.


What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects.

van Eekeren R, Rolfes L, Koster AS, Magro L, Parthasarathi G, Al Ramimmy H, Schutte T, Tanaka D, van Puijenbroek E, Härmark L.

Drug Saf. 2018 Nov;41(11):1003-1011. doi: 10.1007/s40264-018-0681-z.


Vitamin B6 in Health Supplements and Neuropathy: Case Series Assessment of Spontaneously Reported Cases.

van Hunsel F, van de Koppel S, van Puijenbroek E, Kant A.

Drug Saf. 2018 Sep;41(9):859-869. doi: 10.1007/s40264-018-0664-0. Review.


Does patient reporting lead to earlier detection of drug safety signals? A retrospective comparison of time to reporting between patients and healthcare professionals in a global database.

Rolfes L, van Hunsel F, Caster O, Taavola H, Taxis K, van Puijenbroek E.

Br J Clin Pharmacol. 2018 Jul;84(7):1514-1524. doi: 10.1111/bcp.13576. Epub 2018 Apr 19.


Sex Differences in Reported Adverse Drug Reactions of Selective Serotonin Reuptake Inhibitors.

Ekhart C, van Hunsel F, Scholl J, de Vries S, van Puijenbroek E.

Drug Saf. 2018 Jul;41(7):677-683. doi: 10.1007/s40264-018-0646-2.


Using Web-Based Questionnaires to Assess Medication Use During Pregnancy: A Validation Study in 2 Prospectively Enrolled Cohorts.

van Gelder MMHJ, Vorstenbosch S, Te Winkel B, van Puijenbroek EP, Roeleveld N.

Am J Epidemiol. 2018 Feb 1;187(2):326-336. doi: 10.1093/aje/kwx239.


Severe Secondary Polycythemia in a Female-to-Male Transgender Patient While Using Lifelong Hormonal Therapy: A Patient's Perspective.

Ederveen EGT, van Hunsel FPAM, Wondergem MJ, van Puijenbroek EP.

Drug Saf Case Rep. 2018 Feb 2;5(1):6. doi: 10.1007/s40800-018-0075-2.


Risks versus benefits of medication use during pregnancy: what do women perceive?

Mulder B, Bijlsma MJ, Schuiling-Veninga CC, Morssink LP, van Puijenbroek E, Aarnoudse JG, Hak E, de Vries TW.

Patient Prefer Adherence. 2017 Dec 20;12:1-8. doi: 10.2147/PPA.S146091. eCollection 2018.


A prediction model-based algorithm for computer-assisted database screening of adverse drug reactions in the Netherlands.

Scholl JHG, van Hunsel FPAM, Hak E, van Puijenbroek EP.

Pharmacoepidemiol Drug Saf. 2018 Feb;27(2):199-205. doi: 10.1002/pds.4364. Epub 2017 Dec 21.


GA101 P329GLALA, a variant of obinutuzumab with abolished ADCC, ADCP and CDC function but retained cell death induction, is as efficient as rituximab in B-cell depletion and antitumor activity.

Herter S, Herting F, Muth G, van Puijenbroek E, Schlothauer T, Ferrara C, Brady K, Lang S, Bacac M, Mössner E, Umana P, Klein C.

Haematologica. 2018 Feb;103(2):e78-e81. doi: 10.3324/haematol.2017.178996. Epub 2017 Oct 27. No abstract available.


The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study.

Schutte T, van Eekeren R, Richir M, van Staveren J, van Puijenbroek E, Tichelaar J, van Agtmael M.

Naunyn Schmiedebergs Arch Pharmacol. 2018 Jan;391(1):17-26. doi: 10.1007/s00210-017-1430-z. Epub 2017 Oct 23.


When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection.

Klein K, Scholl JHG, De Bruin ML, van Puijenbroek EP, Leufkens HGM, Stolk P.

Clin Pharmacol Ther. 2018 Feb;103(2):296-303. doi: 10.1002/cpt.879. Epub 2017 Oct 25.


Web-based questionnaires to assess perinatal outcome proved to be valid.

van Gelder MMHJ, Vorstenbosch S, Derks L, Te Winkel B, van Puijenbroek EP, Roeleveld N.

J Clin Epidemiol. 2017 Oct;90:136-143. doi: 10.1016/j.jclinepi.2017.07.004. Epub 2017 Jul 18.


Patients' Perspectives on Adverse Drug Reaction Reporting in a Developing Country: A Case Study from Ghana.

Sabblah GT, Darko DM, Mogtari H, Härmark L, van Puijenbroek E.

Drug Saf. 2017 Oct;40(10):911-921. doi: 10.1007/s40264-017-0563-9.


CYP450 genotype and aggressive behavior on selective serotonin reuptake inhibitors.

Ekhart C, Matic M, Kant A, van Puijenbroek E, Schaik RV.

Pharmacogenomics. 2017 May;18(7):613-620. doi: 10.2217/pgs-2017-0197. Epub 2017 May 4.


The Quality of Clinical Information in Adverse Drug Reaction Reports by Patients and Healthcare Professionals: A Retrospective Comparative Analysis.

Rolfes L, van Hunsel F, van der Linden L, Taxis K, van Puijenbroek E.

Drug Saf. 2017 Jul;40(7):607-614. doi: 10.1007/s40264-017-0530-5.


Cergutuzumab amunaleukin (CEA-IL2v), a CEA-targeted IL-2 variant-based immunocytokine for combination cancer immunotherapy: Overcoming limitations of aldesleukin and conventional IL-2-based immunocytokines.

Klein C, Waldhauer I, Nicolini VG, Freimoser-Grundschober A, Nayak T, Vugts DJ, Dunn C, Bolijn M, Benz J, Stihle M, Lang S, Roemmele M, Hofer T, van Puijenbroek E, Wittig D, Moser S, Ast O, Brünker P, Gorr IH, Neumann S, de Vera Mudry MC, Hinton H, Crameri F, Saro J, Evers S, Gerdes C, Bacac M, van Dongen G, Moessner E, Umaña P.

Oncoimmunology. 2017 Jan 11;6(3):e1277306. doi: 10.1080/2162402X.2016.1277306. eCollection 2017.


A global view of undergraduate education in pharmacovigilance.

Hartman J, Härmark L, van Puijenbroek E.

Eur J Clin Pharmacol. 2017 Jul;73(7):891-899. doi: 10.1007/s00228-017-2237-z. Epub 2017 Mar 17.


Inhibition of CYP2D6 with low dose (5 mg) paroxetine in patients with high 10-hydroxynortriptyline serum levels - a review of routine practice.

Jessurun N, van Puijenbroek EP, Otten LS, Mikes O, Vermeulen Windsant A, van Marum RJ, Grootens K, Derijks HJ.

Br J Clin Pharmacol. 2017 May;83(5):1149-1151. doi: 10.1111/bcp.13201. Epub 2017 Jan 29. No abstract available.


Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study.

Schutte T, Tichelaar J, Reumerman MO, van Eekeren R, Rolfes L, van Puijenbroek EP, Richir MC, van Agtmael MA.

Drug Saf. 2017 May;40(5):409-418. doi: 10.1007/s40264-016-0502-1.


Developing a Crowdsourcing Approach and Tool for Pharmacovigilance Education Material Delivery.

Bate A, Beckmann J, Dodoo A, Härmark L, Hartigan-Go K, Hegerius A, Lindquist M, van Puijenbroek E, Tuccori M, Hagemann U.

Drug Saf. 2017 Mar;40(3):191-199. doi: 10.1007/s40264-016-0495-9.


Pharmacovigilance Skills, Knowledge and Attitudes in our Future Doctors - A Nationwide Study in the Netherlands.

Schutte T, Tichelaar J, Reumerman MO, van Eekeren R, Rissmann R, Kramers C, Richir MC, van Puijenbroek EP, van Agtmael MA; Education Committee/Working Group Research in Education of the Dutch Society of Clinical Pharmacology and Biopharmacy (NVKF&B), Utrecht, The Netherlands.

Basic Clin Pharmacol Toxicol. 2017 May;120(5):475-481. doi: 10.1111/bcpt.12712. Epub 2017 Jan 11.


Advanced Age and Female Sex As Risk Factors for High Anion Gap Metabolic Acidosis After a Drug Interaction Between Paracetamol and Flucloxacillin: A Case Series.

Jessurun N, van Marum R, Hermens W, van Puijenbroek E.

J Am Geriatr Soc. 2016 Oct;64(10):e90-e93. doi: 10.1111/jgs.14332. Epub 2016 Sep 2. No abstract available.


Post-Menopausal Vaginal Hemorrhage Related to the Use of a Hop-Containing Phytotherapeutic Product.

van Hunsel F, van de Koppel S, van Puijenbroek E.

Drug Saf Case Rep. 2015 Dec;2(1):14.


Response to the validity and reliability of a signal impact assessment tool: statistical issue to avoid misinterpretation.

Rolfes L, van Hunsel F, van Puijenbroek E.

Pharmacoepidemiol Drug Saf. 2016 Oct;25(10):1217. doi: 10.1002/pds.4084. No abstract available.


The value of time-to-onset in statistical signal detection of adverse drug reactions: a comparison with disproportionality analysis in spontaneous reports from the Netherlands.

Scholl JH, van Puijenbroek EP.

Pharmacoepidemiol Drug Saf. 2016 Dec;25(12):1361-1367. doi: 10.1002/pds.4115. Epub 2016 Sep 30.


Actions in response to drug safety signals arising from a spontaneous reporting system: Retrospective study in The Netherlands.

Rolfes L, Kolfschoten J, van Hunsel F, Kooijman M, van Puijenbroek E.

Int J Risk Saf Med. 2016 Aug 22;28(2):115-23. doi: 10.3233/JRS-160724.


Contraindicated use of 5-alpha-reductase inhibitors in women.

Teichert M, van Puijenbroek E, Stricker BH.

Br J Clin Pharmacol. 2017 Feb;83(2):429-431. doi: 10.1111/bcp.13118. Epub 2016 Sep 30. No abstract available.


The validity and reliability of a signal impact assessment tool.

Rolfes L, Kolfschoten J, van Hunsel F, van Puijenbroek E.

Pharmacoepidemiol Drug Saf. 2016 Jul;25(7):815-9. doi: 10.1002/pds.4038. Epub 2016 May 19.


[The Teratology Information Service: medicines during pregnancy and lactation].

de Vries LC, de Swart IW, van Puijenbroek EP.

Ned Tijdschr Geneeskd. 2016;160:A9900. Dutch.


The Impact of Experiencing Adverse Drug Reactions on the Patient's Quality of Life: A Retrospective Cross-Sectional Study in the Netherlands.

Rolfes L, van Hunsel F, Taxis K, van Puijenbroek E.

Drug Saf. 2016 Aug;39(8):769-76. doi: 10.1007/s40264-016-0422-0.


Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective: a prospective, observational cohort study in the Netherlands.

de Jong L, Härmark L, van Puijenbroek E.

Eur J Clin Pharmacol. 2016 May;72(5):615-22. doi: 10.1007/s00228-016-2019-z. Epub 2016 Feb 11.


Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports.

Klein K, Scholl JH, Vermeer NS, Broekmans AW, Van Puijenbroek EP, De Bruin ML, Stolk P.

Drug Saf. 2016 Feb;39(2):185-92. doi: 10.1007/s40264-015-0383-8.


Premedication and Chemotherapy Agents do not Impair Imgatuzumab (GA201)-Mediated Antibody-Dependent Cellular Cytotoxicity and Combination Therapies Enhance Efficacy.

Gonzalez-Nicolini V, Herter S, Lang S, Waldhauer I, Bacac M, Roemmele M, Bommer E, Freytag O, van Puijenbroek E, Umaña P, Gerdes CA.

Clin Cancer Res. 2016 May 15;22(10):2453-61. doi: 10.1158/1078-0432.CCR-14-2579. Epub 2015 Nov 18.


Parametric time-to-onset models were developed to improve causality assessment of adverse drug reactions from antidiabetic drugs.

Scholl JH, van de Ven PM, van Puijenbroek EP.

J Clin Epidemiol. 2015 Dec;68(12):1423-31. doi: 10.1016/j.jclinepi.2015.03.001. Epub 2015 Mar 9.


Relationship between structural alerts in NSAIDs and idiosyncratic hepatotoxicity: an analysis of spontaneous report data from the WHO database.

Jessurun N, van Puijenbroek E.

Drug Saf. 2015 May;38(5):511-5. doi: 10.1007/s40264-015-0282-z.


Feedback for patients reporting adverse drug reactions; satisfaction and expectations.

Rolfes L, van Hunsel F, van Grootheest K, van Puijenbroek E.

Expert Opin Drug Saf. 2015 May;14(5):625-32. doi: 10.1517/14740338.2015.1021775. Epub 2015 Mar 12.


Six cases of (severe) hypoglycaemia associated with gabapentin use in both diabetic and non-diabetic patients.

Scholl JH, van Eekeren R, van Puijenbroek EP.

Br J Clin Pharmacol. 2015 May;79(5):870-1. doi: 10.1111/bcp.12548. No abstract available.


Adverse events of haloperidol for the treatment of delirium in critically ill children.

Slooff VD, Spaans E, van Puijenbroek E, Jessurun N, van Beusekom BS, de Hoog M, Tibboel D, de Wildt SN.

Intensive Care Med. 2014 Oct;40(10):1602-3. doi: 10.1007/s00134-014-3446-x. Epub 2014 Sep 3. No abstract available.


Adverse drug reaction reports of patients and healthcare professionals-differences in reported information.

Rolfes L, van Hunsel F, Wilkes S, van Grootheest K, van Puijenbroek E.

Pharmacoepidemiol Drug Saf. 2015 Feb;24(2):152-8. doi: 10.1002/pds.3687. Epub 2014 Jul 31.


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