@article{RN486,
   author = {Voss, E. A. and Shoaibi, A. and Yin Hui Lai, L. and Blacketer, C. and Alshammari, T. and Makadia, R. and Haynes, K. and Sena, A. G. and Rao, G. and van Sandijk, S. and Fraboulet, C. and Boyer, L. and Le Carrour, T. and Horban, S. and Morales, D. R. and Martínez Roldán, J. and Ramírez-Anguita, J. M. and Mayer, M. A. and de Wilde, M. and John, L. H. and Duarte-Salles, T. and Roel, E. and Pistillo, A. and Kolde, R. and Maljković, F. and Denaxas, S. and Papez, V. and Kahn, M. G. and Natarajan, K. and Reich, C. and Secora, A. and Minty, E. P. and Shah, N. H. and Posada, J. D. and Garcia Morales, M. T. and Bosca, D. and Cadenas Juanino, H. and Diaz Holgado, A. and Pedrera Jiménez, M. and Serrano Balazote, P. and García Barrio, N. and Şen, S. and Üresin, A. Y. and Erdogan, B. and Belmans, L. and Byttebier, G. and Malbrain, Mlng and Dedman, D. J. and Cuccu, Z. and Vashisht, R. and Butte, A. J. and Patel, A. and Dahm, L. and Han, C. and Bu, F. and Arshad, F. and Ostropolets, A. and Nyberg, F. and Hripcsak, G. and Suchard, M. A. and Prieto-Alhambra, D. and Rijnbeek, P. R. and Schuemie, M. J. and Ryan, P. B.},
   title = {Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort study},
   journal = {EClinicalMedicine},
   volume = {58},
   pages = {101932},
   note = {2589-5370 Voss, Erica A Shoaibi, Azza Yin Hui Lai, Lana Blacketer, Clair Alshammari, Thamir Makadia, Rupa Haynes, Kevin Sena, Anthony G Rao, Gowtham van Sandijk, Sebastiaan Fraboulet, Clement Boyer, Laurent Le Carrour, Tanguy Horban, Scott Morales, Daniel R Martínez Roldán, Jordi Ramírez-Anguita, Juan Manuel Mayer, Miguel A de Wilde, Marcel John, Luis H Duarte-Salles, Talita Roel, Elena Pistillo, Andrea Kolde, Raivo Maljković, Filip Denaxas, Spiros Papez, Vaclav Kahn, Michael G Natarajan, Karthik Reich, Christian Secora, Alex Minty, Evan P Shah, Nigam H Posada, Jose D Garcia Morales, Maria Teresa Bosca, Diego Cadenas Juanino, Honorio Diaz Holgado, Antonio Pedrera Jiménez, Miguel Serrano Balazote, Pablo García Barrio, Noelia Şen, Selçuk Üresin, Ali Yağız Erdogan, Baris Belmans, Luc Byttebier, Geert Malbrain, Manu L N G Dedman, Daniel J Cuccu, Zara Vashisht, Rohit Butte, Atul J Patel, Ayan Dahm, Lisa Han, Cora Bu, Fan Arshad, Faaizah Ostropolets, Anna Nyberg, Fredrik Hripcsak, George Suchard, Marc A Prieto-Alhambra, Dani Rijnbeek, Peter R Schuemie, Martijn J Ryan, Patrick B Journal Article England 2023/04/11 EClinicalMedicine. 2023 Apr;58:101932. doi: 10.1016/j.eclinm.2023.101932. Epub 2023 Apr 4.},
   abstract = {BACKGROUND: Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines, but with COVID-19. Our aim was to characterise the incidence rates of AESIs following SARS-CoV-2 infection in patients and compare these to historical rates in the general population. METHODS: A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a common data model. This study's evidence was collected between Jan 1, 2017 and the conclusion of each database (which ranged from Jul 2020 to May 2022). The 16 pre-specified prevalent AESIs were: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain- Barré syndrome, haemorrhagic stroke, non-haemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, transverse myelitis, and thrombosis with thrombocytopenia. Age-sex standardised incidence rate ratios (SIR) were estimated to compare post-COVID-19 to pre-pandemic rates in each of the databases. FINDINGS: Substantial heterogeneity by age was seen for AESI rates, with some clearly increasing with age but others following the opposite trend. Similarly, differences were also observed across databases for same health outcome and age-sex strata. All studied AESIs appeared consistently more common in the post-COVID-19 compared to the historical cohorts, with related meta-analytic SIRs ranging from 1.32 (1.05 to 1.66) for narcolepsy to 11.70 (10.10 to 13.70) for pulmonary embolism. INTERPRETATION: Our findings suggest all AESIs are more common after COVID-19 than in the general population. Thromboembolic events were particularly common, and over 10-fold more so. More research is needed to contextualise post-COVID-19 complications in the longer term. FUNDING: None.},
   keywords = {Adverse events of special interest
Covid-19
Omop cdm
Observational research ,
ISSN = 2589-5370 ,
DOI = 10.1016/j.eclinm.2023.101932},
   year = {2023},
   type = {Journal Article}
}

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{"propositions":[],"lastnames":["Schuemie"],"firstnames":["M.","J."],"suffixes":[]},{"propositions":[],"lastnames":["Ryan"],"firstnames":["P.","B."],"suffixes":[]}],"title":"Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort study","journal":"EClinicalMedicine","volume":"58","pages":"101932","note":"2589-5370 Voss, Erica A Shoaibi, Azza Yin Hui Lai, Lana Blacketer, Clair Alshammari, Thamir Makadia, Rupa Haynes, Kevin Sena, Anthony G Rao, Gowtham van Sandijk, Sebastiaan Fraboulet, Clement Boyer, Laurent Le Carrour, Tanguy Horban, Scott Morales, Daniel R Martínez Roldán, Jordi Ramírez-Anguita, Juan Manuel Mayer, Miguel A de Wilde, Marcel John, Luis H Duarte-Salles, Talita Roel, Elena Pistillo, Andrea Kolde, Raivo Maljković, Filip Denaxas, Spiros Papez, Vaclav Kahn, Michael G Natarajan, Karthik Reich, Christian Secora, Alex Minty, Evan P Shah, Nigam H Posada, Jose D Garcia Morales, Maria Teresa Bosca, Diego Cadenas Juanino, Honorio Diaz Holgado, Antonio Pedrera Jiménez, Miguel Serrano Balazote, Pablo García Barrio, Noelia Şen, Selçuk Üresin, Ali Yağız Erdogan, Baris Belmans, Luc Byttebier, Geert Malbrain, Manu L N G Dedman, Daniel J Cuccu, Zara Vashisht, Rohit Butte, Atul J Patel, Ayan Dahm, Lisa Han, Cora Bu, Fan Arshad, Faaizah Ostropolets, Anna Nyberg, Fredrik Hripcsak, George Suchard, Marc A Prieto-Alhambra, Dani Rijnbeek, Peter R Schuemie, Martijn J Ryan, Patrick B Journal Article England 2023/04/11 EClinicalMedicine. 2023 Apr;58:101932. doi: 10.1016/j.eclinm.2023.101932. Epub 2023 Apr 4.","abstract":"BACKGROUND: Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines, but with COVID-19. Our aim was to characterise the incidence rates of AESIs following SARS-CoV-2 infection in patients and compare these to historical rates in the general population. METHODS: A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a common data model. This study's evidence was collected between Jan 1, 2017 and the conclusion of each database (which ranged from Jul 2020 to May 2022). The 16 pre-specified prevalent AESIs were: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain- Barré syndrome, haemorrhagic stroke, non-haemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, transverse myelitis, and thrombosis with thrombocytopenia. Age-sex standardised incidence rate ratios (SIR) were estimated to compare post-COVID-19 to pre-pandemic rates in each of the databases. FINDINGS: Substantial heterogeneity by age was seen for AESI rates, with some clearly increasing with age but others following the opposite trend. Similarly, differences were also observed across databases for same health outcome and age-sex strata. All studied AESIs appeared consistently more common in the post-COVID-19 compared to the historical cohorts, with related meta-analytic SIRs ranging from 1.32 (1.05 to 1.66) for narcolepsy to 11.70 (10.10 to 13.70) for pulmonary embolism. INTERPRETATION: Our findings suggest all AESIs are more common after COVID-19 than in the general population. Thromboembolic events were particularly common, and over 10-fold more so. More research is needed to contextualise post-COVID-19 complications in the longer term. FUNDING: None.","keywords":"Adverse events of special interest Covid-19 Omop cdm Observational research , ISSN = 2589-5370 , DOI = 10.1016/j.eclinm.2023.101932","year":"2023","bibtex":"@article{RN486,\r\n author = {Voss, E. A. and Shoaibi, A. and Yin Hui Lai, L. and Blacketer, C. and Alshammari, T. and Makadia, R. and Haynes, K. and Sena, A. G. and Rao, G. and van Sandijk, S. and Fraboulet, C. and Boyer, L. and Le Carrour, T. and Horban, S. and Morales, D. R. and Martínez Roldán, J. and Ramírez-Anguita, J. M. and Mayer, M. A. and de Wilde, M. and John, L. H. and Duarte-Salles, T. and Roel, E. and Pistillo, A. and Kolde, R. and Maljković, F. and Denaxas, S. and Papez, V. and Kahn, M. G. and Natarajan, K. and Reich, C. and Secora, A. and Minty, E. P. and Shah, N. H. and Posada, J. D. and Garcia Morales, M. T. and Bosca, D. and Cadenas Juanino, H. and Diaz Holgado, A. and Pedrera Jiménez, M. and Serrano Balazote, P. and García Barrio, N. and Şen, S. and Üresin, A. Y. and Erdogan, B. and Belmans, L. and Byttebier, G. and Malbrain, Mlng and Dedman, D. J. and Cuccu, Z. and Vashisht, R. and Butte, A. J. and Patel, A. and Dahm, L. and Han, C. and Bu, F. and Arshad, F. and Ostropolets, A. and Nyberg, F. and Hripcsak, G. and Suchard, M. A. and Prieto-Alhambra, D. and Rijnbeek, P. R. and Schuemie, M. J. and Ryan, P. B.},\r\n title = {Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort study},\r\n journal = {EClinicalMedicine},\r\n volume = {58},\r\n pages = {101932},\r\n note = {2589-5370 Voss, Erica A Shoaibi, Azza Yin Hui Lai, Lana Blacketer, Clair Alshammari, Thamir Makadia, Rupa Haynes, Kevin Sena, Anthony G Rao, Gowtham van Sandijk, Sebastiaan Fraboulet, Clement Boyer, Laurent Le Carrour, Tanguy Horban, Scott Morales, Daniel R Martínez Roldán, Jordi Ramírez-Anguita, Juan Manuel Mayer, Miguel A de Wilde, Marcel John, Luis H Duarte-Salles, Talita Roel, Elena Pistillo, Andrea Kolde, Raivo Maljković, Filip Denaxas, Spiros Papez, Vaclav Kahn, Michael G Natarajan, Karthik Reich, Christian Secora, Alex Minty, Evan P Shah, Nigam H Posada, Jose D Garcia Morales, Maria Teresa Bosca, Diego Cadenas Juanino, Honorio Diaz Holgado, Antonio Pedrera Jiménez, Miguel Serrano Balazote, Pablo García Barrio, Noelia Şen, Selçuk Üresin, Ali Yağız Erdogan, Baris Belmans, Luc Byttebier, Geert Malbrain, Manu L N G Dedman, Daniel J Cuccu, Zara Vashisht, Rohit Butte, Atul J Patel, Ayan Dahm, Lisa Han, Cora Bu, Fan Arshad, Faaizah Ostropolets, Anna Nyberg, Fredrik Hripcsak, George Suchard, Marc A Prieto-Alhambra, Dani Rijnbeek, Peter R Schuemie, Martijn J Ryan, Patrick B Journal Article England 2023/04/11 EClinicalMedicine. 2023 Apr;58:101932. doi: 10.1016/j.eclinm.2023.101932. Epub 2023 Apr 4.},\r\n abstract = {BACKGROUND: Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines, but with COVID-19. Our aim was to characterise the incidence rates of AESIs following SARS-CoV-2 infection in patients and compare these to historical rates in the general population. METHODS: A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a common data model. This study's evidence was collected between Jan 1, 2017 and the conclusion of each database (which ranged from Jul 2020 to May 2022). The 16 pre-specified prevalent AESIs were: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain- Barré syndrome, haemorrhagic stroke, non-haemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, transverse myelitis, and thrombosis with thrombocytopenia. Age-sex standardised incidence rate ratios (SIR) were estimated to compare post-COVID-19 to pre-pandemic rates in each of the databases. FINDINGS: Substantial heterogeneity by age was seen for AESI rates, with some clearly increasing with age but others following the opposite trend. Similarly, differences were also observed across databases for same health outcome and age-sex strata. All studied AESIs appeared consistently more common in the post-COVID-19 compared to the historical cohorts, with related meta-analytic SIRs ranging from 1.32 (1.05 to 1.66) for narcolepsy to 11.70 (10.10 to 13.70) for pulmonary embolism. INTERPRETATION: Our findings suggest all AESIs are more common after COVID-19 than in the general population. Thromboembolic events were particularly common, and over 10-fold more so. More research is needed to contextualise post-COVID-19 complications in the longer term. FUNDING: None.},\r\n keywords = {Adverse events of special interest\r\nCovid-19\r\nOmop cdm\r\nObservational research ,\r\nISSN = 2589-5370 ,\r\nDOI = 10.1016/j.eclinm.2023.101932},\r\n year = {2023},\r\n type = {Journal Article}\r\n}\r\n\r\n","author_short":["Voss, E. A.","Shoaibi, A.","Yin Hui Lai, L.","Blacketer, C.","Alshammari, T.","Makadia, R.","Haynes, K.","Sena, A. G.","Rao, G.","van Sandijk, S.","Fraboulet, C.","Boyer, L.","Le Carrour, T.","Horban, S.","Morales, D. R.","Martínez Roldán, J.","Ramírez-Anguita, J. M.","Mayer, M. A.","de Wilde, M.","John, L. H.","Duarte-Salles, T.","Roel, E.","Pistillo, A.","Kolde, R.","Maljković, F.","Denaxas, S.","Papez, V.","Kahn, M. G.","Natarajan, K.","Reich, C.","Secora, A.","Minty, E. P.","Shah, N. H.","Posada, J. D.","Garcia Morales, M. T.","Bosca, D.","Cadenas Juanino, H.","Diaz Holgado, A.","Pedrera Jiménez, M.","Serrano Balazote, P.","García Barrio, N.","Şen, S.","Üresin, A. Y.","Erdogan, B.","Belmans, L.","Byttebier, G.","Malbrain, M.","Dedman, D. J.","Cuccu, Z.","Vashisht, R.","Butte, A. J.","Patel, A.","Dahm, L.","Han, C.","Bu, F.","Arshad, F.","Ostropolets, A.","Nyberg, F.","Hripcsak, G.","Suchard, M. A.","Prieto-Alhambra, D.","Rijnbeek, P. R.","Schuemie, M. J.","Ryan, P. 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