{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T17:42:15Z","timestamp":1775670135161,"version":"3.50.1"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,12,22]],"date-time":"2020-12-22T00:00:00Z","timestamp":1608595200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2020,12,22]],"date-time":"2020-12-22T00:00:00Z","timestamp":1608595200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2021,1]]},"DOI":"10.1007\/s40264-020-01035-x","type":"journal-article","created":{"date-parts":[[2020,12,22]],"date-time":"2020-12-22T20:02:26Z","timestamp":1608667346000},"page":"95-105","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor\u2019s Perspective"],"prefix":"10.1007","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6190-9432","authenticated-orcid":false,"given":"Elena","family":"Beyzarov","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rob","family":"Julg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Naim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jigna","family":"Shah","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William W.","family":"Gregory","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ayman","family":"Ayoub","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick","family":"Caubel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,12,22]]},"reference":[{"key":"1035_CR1","unstructured":"European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Annex I - Definitions (Rev 4); 9 Oct 2017. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-good-pharmacovigilance-practices-annex-i-definitions-rev-4_en.pdf"},{"key":"1035_CR2","unstructured":"Centers for Disease Control and Prevention. CDC coronavirus disease 2019 (COVID-19): people with certain medical conditions. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/need-extra-precautions\/people-with-medical-conditions.html. Accessed 14 Sep 2020."},{"key":"1035_CR3","unstructured":"Centers for Disease Control and Prevention. CDC COVID data tracker. https:\/\/covid.cdc.gov\/covid-data-tracker\/. Accessed 26 Oct 2020."},{"key":"1035_CR4","doi-asserted-by":"crossref","unstructured":"Walz L, Cohen AJ, Rebaza AP, Vanchieri J, Slade MD, Cruz CSD, et al. JAK-inhibitor and type I interferon ability to produce favorable clinical outcomes in COVID-19 patients: a systematic review and meta-analysis. Res Sq. 2020:rs.3.rs-64782.","DOI":"10.21203\/rs.3.rs-64782\/v1"},{"key":"1035_CR5","doi-asserted-by":"publisher","first-page":"1911","DOI":"10.1111\/ajt.15936","volume":"20","author":"JJ Hsu","year":"2020","unstructured":"Hsu JJ, Gaynor P, Kamath M, Fan A, Al-Saffar F, Cruz D, et al. COVID-19 in a high-risk dual heart and kidney transplant recipient. Am J Transplant. 2020;20:1911\u20135.","journal-title":"Am J Transplant."},{"key":"1035_CR6","doi-asserted-by":"publisher","first-page":"e64","DOI":"10.1093\/ibd\/izaa093","volume":"26","author":"J Jacobs","year":"2020","unstructured":"Jacobs J, Clark-Snustad K, Lee S. Case report of a SARS-CoV-2 infection in a patient with ulcerative colitis on tofacitinib. Inflamm Bowel Dis. 2020;26:e64.","journal-title":"Inflamm Bowel Dis."},{"key":"1035_CR7","doi-asserted-by":"publisher","first-page":"680","DOI":"10.1016\/j.semarthrit.2020.05.010","volume":"50","author":"S Sharmeen","year":"2020","unstructured":"Sharmeen S, Elghawy A, Zarlasht F, Yao Q. COVID-19 in rheumatic disease patients on immunosuppressive agents. Semin Arthritis Rheum. 2020;50:680\u20136.","journal-title":"Semin Arthritis Rheum."},{"key":"1035_CR8","doi-asserted-by":"publisher","first-page":"1864","DOI":"10.1111\/ajt.15897","volume":"20","author":"L Ning","year":"2020","unstructured":"Ning L, Liu L, Li W, Liu H, Wang J, Yao Z, et al. Novel coronavirus (SARS-CoV-2) infection in a renal transplant recipient: case report. Am J Transplant. 2020;20:1864\u20138.","journal-title":"Am J Transplant."},{"key":"1035_CR9","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1056\/NEJMc2009567","volume":"383","author":"R Haberman","year":"2020","unstructured":"Haberman R, Axelrad J, Chen A, Castillo R, Yan D, Izmirly P, et al. Covid-19 in immune-mediated inflammatory diseases: case series from New York. N Engl J Med. 2020;383:85\u20138.","journal-title":"N Engl J Med."},{"key":"1035_CR10","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2021436","author":"P Horby","year":"2020","unstructured":"Recovery Collaborative Group, Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, et al. Dexamethasone in hospitalized patients with Covid-19: preliminary report. N Engl J Med. 2020. https:\/\/doi.org\/10.1056\/NEJMoa2021436.","journal-title":"N Engl J Med."},{"key":"1035_CR11","doi-asserted-by":"publisher","first-page":"1320","DOI":"10.1111\/jth.14871","volume":"18","author":"S Testa","year":"2020","unstructured":"Testa S, Prandoni P, Paoletti O, Morandini R, Tala M, Dellanoce C, et al. Direct oral anticoagulant plasma levels\u2019 striking increase in severe COVID-19 respiratory syndrome patients treated with antiviral agents: the Cremona experience. J Thromb Haemost. 2020;18:1320\u20133.","journal-title":"J Thromb Haemost."},{"key":"1035_CR12","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2020.08.022","author":"T Fiolet","year":"2020","unstructured":"Fiolet T, Guihur A, Rebeaud ME, Mulot M, Peiffer-Smadja N, Mahamat-Saleh Y. Effect of hydroxychloroquine with or without azithromycin on the mortality of coronavirus disease 2019 (COVID-19) patients: a systematic review and meta-analysis. Clin Microbiol Infect. 2020. https:\/\/doi.org\/10.1016\/j.cmi.2020.08.022.","journal-title":"Clin Microbiol Infect."},{"key":"1035_CR13","doi-asserted-by":"publisher","first-page":"959","DOI":"10.1016\/S0140-6736(20)31862-6","volume":"396","author":"RHM Furtado","year":"2020","unstructured":"Furtado RHM, Berwanger O, Fonseca HA, Correa TD, Ferraz LR, Lapa MG, et al. Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial. Lancet. 2020;396:959\u201367.","journal-title":"Lancet"},{"key":"1035_CR14","doi-asserted-by":"publisher","first-page":"106143","DOI":"10.1016\/j.ijantimicag.2020.106143","volume":"56","author":"E Sekhavati","year":"2020","unstructured":"Sekhavati E, Jafari F, SeyedAlinaghi S, Jamalimoghadamsiahkali S, Sadr S, Tabarestani M, et al. Safety and effectiveness of azithromycin in patients with COVID-19: an open-label randomised trial. Int J Antimicrob Agents. 2020;56:106143.","journal-title":"Int J Antimicrob Agents."},{"key":"1035_CR15","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1007\/s11886-020-01292-3","volume":"22","author":"H Zhu","year":"2020","unstructured":"Zhu H, Rhee JW, Cheng P, Waliany S, Chang A, Witteles RM, et al. Cardiovascular complications in patients with COVID-19: consequences of viral toxicities and host immune response. Curr Cardiol Rep. 2020;22:32.","journal-title":"Curr Cardiol Rep."},{"key":"1035_CR16","doi-asserted-by":"publisher","first-page":"831","DOI":"10.1001\/jamacardio.2020.1286","volume":"5","author":"M Madjid","year":"2020","unstructured":"Madjid M, Safavi-Naeini P, Solomon SD, Vardeny O. Potential effects of coronaviruses on the cardiovascular system: a review. JAMA Cardiol. 2020;5:831\u201340.","journal-title":"JAMA Cardiol."},{"key":"1035_CR17","doi-asserted-by":"publisher","first-page":"101791","DOI":"10.1016\/j.tmaid.2020.101791","volume":"36","author":"JC Lagier","year":"2020","unstructured":"Lagier JC, Million M, Gautret P, Colson P, Cortaredona S, Giraud-Gatineau A, et al. Outcomes of 3,737 COVID-19 patients treated with hydroxychloroquine\/azithromycin and other regimens in Marseille, France: a retrospective analysis. Travel Med Infect Dis. 2020;36:101791.","journal-title":"Travel Med Infect Dis."}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-020-01035-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s40264-020-01035-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-020-01035-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,1,18]],"date-time":"2021-01-18T17:10:35Z","timestamp":1610989835000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s40264-020-01035-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,12,22]]},"references-count":17,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,1]]}},"alternative-id":["1035"],"URL":"https:\/\/doi.org\/10.1007\/s40264-020-01035-x","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,12,22]]},"assertion":[{"value":"15 December 2020","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 December 2020","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This work was supported by Pfizer Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Elena Beyzarov, Yan Chen, Rob Julg, Karen Naim, Jigna Shah, William W. Gregory, Ayman Ayoub, and Patrick Caubel are employees of Pfizer Inc. and may hold stock or stock options.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The analyses for this study were conducted retrospectively using deidentified patient data; as such, this study was deemed exempt by the institutional review board and informed consent was not required.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"Upon request, and subject to certain criteria, conditions, and exceptions (see  for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the USA and\/or European Union or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"No specific custom code was created for the study. We utilized an SAP Business Objects (Desktop Intelligence Version 12.6.2.1782) based application to analyze the study data. For more details, please contact the corresponding author.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors met the below criteria for authorship: substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; and drafting the work or revising it critically for important intellectual content; and final approval of the version to be published; and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}