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Antidepressant use during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies and methodological considerations

BMC medicine, 2018-01, Vol.16 (1), p.6-6, Article 6

2018

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Comparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases

Drug safety, 2015-06, Vol.38 (6), p.577-587

2015

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Patient Reporting in the EU: Analysis of EudraVigilance Data

Drug safety, 2017-07, Vol.40 (7), p.629-645

2017

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An Empirical Approach to Explore the Relationship Between Measures of Disproportionate Reporting and Relative Risks from Analytical Studies

Drug safety, 2016-01, Vol.39 (1), p.29-43

2016

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Sharing clinical trial data on patient level: Opportunities and challenges

Biometrical journal, 2015-01, Vol.57 (1), p.8-26

2015

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Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?

Pharmacoepidemiology and drug safety, 2020-10, Vol.29 (10), p.1336-1340

2020

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Measuring Signal Detection Performance: Can We Trust Negative Controls and Do We Need Them?

Drug safety, 2016-05, Vol.39 (5), p.371-373

Slattery, Jim

2016

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Antiepileptic drug use in seven electronic health record databases in Europe: A methodologic comparison

Epilepsia (Copenhagen), 2014-05, Vol.55 (5), p.666-673

2014

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Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance

Vaccine, 2011-06, Vol.29 (26), p.4378-4387

2011

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Time trends of period prevalence rates of patients with inhaled long-acting beta-2-agonists-containing prescriptions: a European comparative database study

PloS one, 2015-02, Vol.10 (2), p.e0117628-e0117628

2015

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Case-only designs for studying the association of antidepressants and hip or femur fracture

Pharmacoepidemiology and drug safety, 2016-03, Vol.25 (S1), p.103-113

2016

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Association between hydrochlorothiazide exposure and different incident skin, lip and oral cavity cancers: A series of population‐based nested case–control studies

British journal of clinical pharmacology, 2020-07, Vol.86 (7), p.1336-1345

2020

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Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice

Drug safety, 2018-10, Vol.41 (10), p.951-958

2018

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Is the EuroQol a valid measure of health-related quality of life after stroke?

Stroke (1970), 1997-10, Vol.28 (10), p.1876-1882

1997

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Evaluation of a stroke family care worker: results of a randomised controlled trial

BMJ (Online), 1997-04, Vol.314 (7087), p.1071

International edition, 1997

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EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection

Drug safety, 2018-07, Vol.41 (7), p.665-675

2018

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The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions

Drug safety, 2022-01, Vol.45 (1), p.83-95

2022

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Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case–Control Study

Clinical drug investigation, 2019-02, Vol.39 (2), p.205-213

2019

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Choosing Thresholds for Statistical Signal Detection with the Proportional Reporting Ratio

Drug safety, 2013-08, Vol.36 (8), p.687-692

2013

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Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?: A Validation Study Based on Prescribing Codeine in Children

Clinical pharmacology and therapeutics, 2020-04, Vol.107 (4), p.915-925

2020

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Ondansetron use in nausea and vomiting during pregnancy: A descriptive analysis of prescription patterns and patient characteristics in UK general practice

British journal of clinical pharmacology, 2022-10, Vol.88 (10), p.4526-4539

2022

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Is There an Increased Risk of Hepatotoxicity with Metamizole? A Comparative Cohort Study in Incident Users

Drug safety, 2021-09, Vol.44 (9), p.973-985

2021

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Does additional monitoring status increase the reporting of adverse drug reactions? An interrupted time series analysis of EudraVigilance data

Pharmacoepidemiology and drug safety, 2021-03, Vol.30 (3), p.350-359

2021

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Validation of Statistical Signal Detection Procedures in EudraVigilance Post-Authorization Data: A Retrospective Evaluation of the Potential for Earlier Signalling

Drug safety, 2010-06, Vol.33 (6), p.475-487

2010

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Different Strategies to Execute Multi‐Database Studies for Medicines Surveillance in Real‐World Setting: A Reflection on the European Model

Clinical pharmacology and therapeutics, 2020-08, Vol.108 (2), p.228-235

2020

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Antidepressant use during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies and methodological considerations

Comparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases

Patient Reporting in the EU: Analysis of EudraVigilance Data

An Empirical Approach to Explore the Relationship Between Measures of Disproportionate Reporting and Relative Risks from Analytical Studies

Sharing clinical trial data on patient level: Opportunities and challenges

Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?

Measuring Signal Detection Performance: Can We Trust Negative Controls and Do We Need Them?

Antiepileptic drug use in seven electronic health record databases in Europe: A methodologic comparison

Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance

Time trends of period prevalence rates of patients with inhaled long-acting beta-2-agonists-containing prescriptions: a European comparative database study

Case-only designs for studying the association of antidepressants and hip or femur fracture

Association between hydrochlorothiazide exposure and different incident skin, lip and oral cavity cancers: A series of population‐based nested case–control studies

Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General Practice

Is the EuroQol a valid measure of health-related quality of life after stroke?

Evaluation of a stroke family care worker: results of a randomised controlled trial

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection

The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions

Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case–Control Study

Choosing Thresholds for Statistical Signal Detection with the Proportional Reporting Ratio

Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?: A Validation Study Based on Prescribing Codeine in Children

Ondansetron use in nausea and vomiting during pregnancy: A descriptive analysis of prescription patterns and patient characteristics in UK general practice

Is There an Increased Risk of Hepatotoxicity with Metamizole? A Comparative Cohort Study in Incident Users

Does additional monitoring status increase the reporting of adverse drug reactions? An interrupted time series analysis of EudraVigilance data

Validation of Statistical Signal Detection Procedures in EudraVigilance Post-Authorization Data: A Retrospective Evaluation of the Potential for Earlier Signalling

Different Strategies to Execute Multi‐Database Studies for Medicines Surveillance in Real‐World Setting: A Reflection on the European Model

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