How patient characteristics shape drug safety

This OFF-X product walkthrough (subtitled "Leveraging OFF-X insights to design smart clinical trials") uses the Bcl-2 inhibitor lisaftoclax -- approved in China as the first Bcl-2 inhibitor with conditional marketing authorization for CLL/SLL there, and the second Bcl-2 inhibitor approved globally -- as its worked example. It shows that lisaftoclax's safety profile in CLL patients features three co-occurring metabolic adverse events (hyperuricaemia, hyperphosphataemia, and hypertriglyceridaemia) not consistently seen together across other patient conditions, and that this specific three-event combination is not shared by other Bcl-2 inhibitors, including venetoclax (FDA-approved for CLL in 2016), when benchmarked side by side. The stated outcome is that OFF-X let users uncover, in minutes, this CLL-specific safety association, which can help tailor risk-mitigation strategies and inform future trial inclusion/exclusion criteria and safety-biomarker endpoints.

The customer is anonymised in Clarivate’s own case study — not withheld by us.

Clarivate owns Cortellis, the curated competitive-intelligence and pipeline-tracking platform standard in pharma portfolio-management teams.

This sits in the Data Providers stage of the AI use-case lifecycle: Named examples from the real-world-data, claims and competitive-intelligence providers pharma AI systems are trained on, benchmarked against, or run inside of.