Table 3.

Significant safety signals of serious adverse events associated with biologic response modifiers (EBGM ≥2)

Drug	Adverse event PT	No. of reports *	EBGM (EB05–EB95)
Antithymocyte immunoglobulin	Therapeutic response decreased	10	3.67 (1.47–6.22)
	Pulmonary edema	16	2.73 (1.31–4.28)
	Hypotension	15	2.64 (1.25–4.28)
	Serum sickness	10	2.37 (1.08–4.67)
	Infusion related reaction	10	2.26 (1.07–4.54)
	Anaphylactic reaction	7	2.10 (1.00–5.01)
Azathioprine	Alternaria infection	6	4.50 (1.27–8.88)
	Fungal skin infection	5	3.06 (1.03–7.55)
	Lymphoproliferative disorder	7	2.17 (1.00–5.14)
Cyclosporine	Neurotoxicity	19	4.02 (2.74–5.74)**
	Graft versus host disease	28	3.00 (2.18–4.06)**
	Thyroid cancer	11	2.92 (1.20–5.12)
Cyclophosphamide	Disease progression	9	3.31 (1.22–6.03)
Daclizumab	Cytomegalovirus infection	22	2.36 (1.30–3.53)
Tacrolimus	Coma	10	2.40 (1.08–4.71)
	Tremor	14	2.27 (1.13–3.99)

EBGM: Empirical Bayes geometric mean

EB05–EB95: 95% confidence interval

PT: Preferred term

^*Total number of reports with significant signals (n=199)

^**Significant safety signals that warrant regulatory action (both EBGM and EB05 ≥2)