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Original Research

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Bruton’s tyrosine kinase inhibitors (BTKis) single and its combination therapy

ORCID Icon, , , , , , & ORCID Icon show all
Pages 627-636 | Received 05 Oct 2023, Accepted 03 Jan 2024, Published online: 18 Mar 2024

Figures & data

Table 1. Characteristics of patients at risk of AEs using BTK inhibitors based on the FAERS database.

Figure 1. Overlapping common preferred terms (PTs) for the top 20 adverse events (AEs) associated with ibrutinib, acalabrutinib and zanubrutinib.

AEs: adverse events.
Figure 1. Overlapping common preferred terms (PTs) for the top 20 adverse events (AEs) associated with ibrutinib, acalabrutinib and zanubrutinib.

Figure 2. Forest plot of the overlapping common preferred terms (PTs) for the top 20 adverse events (AEs) associated with ibrutinib, acalabrutinib and zanubrutinib.

PT, preferred term; CI, confidence interval; ROR, reporting odds ratio.
Figure 2. Forest plot of the overlapping common preferred terms (PTs) for the top 20 adverse events (AEs) associated with ibrutinib, acalabrutinib and zanubrutinib.

Table 2. Reporting odds ratios (RORs) of the top 20 AEs associated with ibrutinib, acalabrutinib, and zanubrutinib.

Figure 3. Heatmap of the reporting odds ratios (RORs) for the top 20 adverse events (AEs) associated with ibrutinib and acalabrutinib across different age groups.

Construct a heatmap representing the reporting odds ratios (RORs) signal values associated with the top 20 adverse reactions (AEs) linked to ibrutinib and acalabrutinib, categorized by age groups. A color gradient is used to indicate the signal values: a shift toward red signifies a higher signal value, while a shift toward yellow indicates a lower signal value. White cells represent that the AE is not in the top 20 of this group.
Figure 3. Heatmap of the reporting odds ratios (RORs) for the top 20 adverse events (AEs) associated with ibrutinib and acalabrutinib across different age groups.

Figure 4. Summary of the time to onset of adverse reactions for ibrutinib and its four combination therapy regimens.

a,b,c,d and e are summaries of the time to onset of adverse reactions for ibrutinib monotherapy and its combination with rituximab, obinutuzumab, venetoclax, and lenalidomide, respectively.
Figure 4. Summary of the time to onset of adverse reactions for ibrutinib and its four combination therapy regimens.

Figure 5. Forest plot of the overlapping common preferred terms (PTs) for the top 20 adverse events (AEs) associated with ibrutinib in combination with rituximab, obinutuzumab, lenalidomide and venetoclax.

PT, preferred term; CI, confidence interval; ROR, reporting odds ratio.
Figure 5. Forest plot of the overlapping common preferred terms (PTs) for the top 20 adverse events (AEs) associated with ibrutinib in combination with rituximab, obinutuzumab, lenalidomide and venetoclax.

Table 3. Reporting odds ratios (RORs) of the top 20 adverse events (AEs) associated with ibrutinib in combination with rituximab, obinutuzumab, lenalidomide and venetoclax.