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Article History

Accepted: 9 August 2022

First Online: 2 October 2022

Declarations

:

: EYFW, CSLC and ICKW had the original idea for the study, contributed to the development of the study, extracted data from the source database, constructed the study design and the statistical model, reviewed the literature, and act as guarantors for this study. EYFW, WX and VKCY undertook the statistical analysis. EYFW, AHYM and ICKW wrote the first draft of the manuscript. ICKW is the principal investigator and provided oversight for all aspects of this project. CSLC, AHYM, FTTL, XL, CKHW, EWYC, DTWL, KCBT, IFNH, CLKL and GML provided critical input to the analyses, design and discussion. All authors contributed to the interpretation of the analysis, critically reviewed and revised the manuscript, and approved the final manuscript as submitted

: This regulatory pharmacovigilance study was initiated by the Department of Health, HKSAR. The Food and Health Bureau of the HKSAR government provided funding for this study. The sponsor of this study was involved in the study design and data collection via the Department of Health. The corresponding author had full access to all the data in the study and took final responsibility for the decision to submit this study for publication.

: EYFW has received research grants from the Food and Health Bureau of the Government of the HKSAR, and the Hong Kong Research Grants Council (RGC), outside the submitted work. CSLC has received grants from the Food and Health Bureau of the Hong Kong Government, Hong Kong RGC, Hong Kong Innovation and Technology Commission, Pfizer, IQVIA, and Amgen, and personal fees from Primevigilance Ltd, outside the submitted work. FTTL has been supported by the RGC Postdoctoral Fellowship under the Hong Kong RGC and has received research grants from the Food and Health Bureau of the Government of the HKSAR, outside the submitted work. EWYC reports honorarium from the HA and grants from the Hong Kong RGC, the Research Fund Secretariat of the Food and Health Bureau, the National Natural Science Fund of China, Wellcome Trust, Bayer, Bristol-Myers Squibb, Pfizer, Janssen, Amgen, Takeda, and the Narcotics Division of the Security Bureau of HKSAR, outside the submitted work. XL has received research grants from the Food and Health Bureau of the Government of the HKSAR; research and educational grants from Janssen and Pfizer; internal funding from the University of Hong Kong; and consultancy fees from Merck Sharp & Dohme, unrelated to this work. CKHW reports receipt of the General Research Fund, RGC, Government of HKSAR, and EuroQol Research Foundation, all outside the submitted work. IFNH has received speaker’s fees from Merck Sharp & Dohme. ICKW reports research funding outside the submitted work from Amgen, Bristol-Myers Squibb, Pfizer, Janssen, Bayer, GSK, Novartis, the Hong Kong RGC, the Hong Kong Health and Medical Research Fund, National Institute for Health Research in England, European Commission, and National Health and Medical Research Council in Australia, and has also received speaker’s fees from Janssen and Medice in the previous 3 years. He is also an independent non-executive director of Jacobson Medical in Hong Kong. Anna Hoi Ying Mok, Wanchun Xu, Vincent Ka Chun Yan, David Tak Wai Lui, Kathryn Choon Beng Tan, Ivan Fan Ngai Hung, Cindy Lo Kuen Lam, and Gabriel Matthew Leung have no known conflicts of interest to report.

: Ethical approval for this study was granted by the Institutional Review Board of the University of Hong Kong/HA Hong Kong West Cluster (UW21-149 and UW21-138) and the Department of Health Ethics Committee (LM21/2021).

: Consent from participants was not required as this study extracted anonymous data from an electronic health database under Hong Kong regulations and approval from the HA and the Department of Health.

: Data will not be available for others as the data custodians have not given permission.

: The modified SCCS for investigating event-dependent exposure was conducted using the R function ‘eventdepenexp’ in the R-package ‘SCCS’. The R code will not be shared as it contains information about the dataset that is confidential.

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