Sathe, Abhishek G.
Singh, Indrajeet
Singh, Pratap
Diderichsen, Paul M.
Wang, Xiaohui
Chang, Peter
Taqui, Atiya
Phan, See
Girish, Sandhya
Othman, Ahmed A. http://orcid.org/0000-0002-4937-2775
Funding for this research was provided by:
Gilead Sciences
Article History
Accepted: 6 March 2024
First Online: 5 April 2024
Declarations
:
: This study was sponsored by Gilead Sciences, Inc.
: Abhishek G. Sathe is an employee of and holds stocks in Gilead Sciences, Inc. Indrajeet Singh was an employee at Gilead Sciences, Inc. Pratap Singh was an employee at Gilead Sciences, Inc. Paul M. Diderichsen is an employee of Certara and received support for the current manuscript and consulting fees from Gilead Sciences, Inc. Xiaohui Wang is an employee of Certara and received support for the current manuscript and consulting fees from Gilead Sciences, Inc. Peter Chang is an employee of and holds stock in Certara and received support for the current manuscript and consulting fees from Gilead Sciences, Inc. Atiya Taqui is an employee of and holds stocks in Gilead Sciences, Inc. See Phan is an employee of and holds stocks in Gilead Sciences, Inc. Sandhya Girish is an employee of and holds stocks in Gilead Sciences, Inc. and received grants and consulting fees from Certara. Ahmed A. Othman is an employee of and holds stocks in Gilead Science, Inc.
: Gilead Sciences, Inc. shares anonymized individual patient data upon request or as required by law or regulation with qualified external researchers based on submitted curriculum vitae and reflecting non-conflict of interest. The request proposal must also include a statistician. Approval of such requests is at the discretion of Gilead Sciences, Inc. and is dependent on the nature of the request, the merit of the research proposed, the availability of the data, and the intended use of the data. Data requests should be sent to datarequest@gilead.com.
: The samples used were obtained from two clinical trials, IMMU-132-01 and [CitationRef removed] ASCENT [CitationRef removed]. These clinical trial study protocols were approved by the Institutional Review Boards at the participating study sites, conducted in compliance with the ethical principles originating in the Declaration of Helsinki, and conducted according to the International Conference on Harmonisation Guidelines for Good Clinical Practices.
: Model code for SG, free SN-38, and total antibody final models are reported in the electronic supplementary material, Section 6.
: AGS, IS, and AAO wrote the manuscript, designed and performed research, and analyzed data. PS designed research. PMD designed and performed research and analyzed data. XW and PC performed research and analyzed data. AT performed research. SP and SG analyzed data. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.