Table 2.

Disproportionality analysis of pneumonia associated with BTK inhibitors in FAERS and JADER.

Signal metric	FAERS				JADER
Signal metric	Ibrutinib	Acalabrutinib	Zanubrutinib	Pirtobrutinib	Ibrutinib	Acalabrutinib	Zanubrutinib	Pirtobrutinib
Pneumonia records, n	2,760	252	86	29	88	16	1	7
ROR (95% CI)	2.46 (2.37–2.56)	1.89 (1.67–2.14)	1.90 (1.54–2.35)	4.86 (3.36–7.03)	4.52 (3.64–5.60)	5.88 (3.54–9.77)	1.38 (0.19–10.00)	5.12 (2.38–10.99)
PRR (chi-square)	2.44 (2344.91)	1.88 (104.18)	1.89 (36.39)	4.77 (86.81)	4.33 (226.99)	5.54 (60.24)	1.38 (0.11)	4.87 (21.77)
EBGM (EBGM05)	2.43 (2.34)	1.88 (1.66)	1.89 (1.53)	4.77 (3.30)	4.31 (3.48)	5.54 (3.33)	1.38 (0.19)	4.87 (2.27)
IC (IC025)	1.28 (1.23)	0.91 (0.72)	0.92 (0.59)	2.25 (1.55)	2.11 (1.74)	2.47 (1.40)	0.46 (−1.87)	2.28 (0.65)
Positive algorithms, n/4	4/4	2/4	2/4	4/4	4/4	4/4	0/4	4/4

Positive criteria: ROR, a≥3 and lower 95% CI>1; PRR, a≥3, PRR≥2 and chi-square≥4; BCPNN, IC025>0; MGPS, EBGM05>2. CI, confidence interval; EBGM, empirical Bayes geometric mean; IC, information component; PRR, proportional reporting ratio; ROR, reporting odds ratio. All disproportionality metrics in this table are derived from spontaneous reporting data and reflect the strength of reporting signals rather than actual clinical incidence or risk.

Bold values indicate that the corresponding algorithm-specific signal-detection criterion was met.