Table 2.

Signal strength of AEs related to HPIs at the system organ class (SOC) level. Signal strength was categorized based on the lower bound of the ROR 95% confidence interval (ROR05): ++ (strong): ROR05 > 2; + (potential): ROR05 > 1; - (no signal): ROR05 ≤ 1. ROR, reporting odds ratio; CI, confidence interval.

	Sonidegib			Vismodegib
SOC	Reports	ROR (95% CI)	Signal Strength	Reports	ROR (95% CI)	Signal Strength
Surgical and medical procedures	115	3.43 (2.84, 4.14)	++	121	0.43 (0.36, 0.51)	-
Musculoskeletal and connective tissue disorders	264	2.24 (1.97, 2.55)	+	2771	2.84 (2.73, 2.96)	++
Metabolism and nutrition disorders	95	1.97 (1.60, 2.41)	+	1024	2.52 (2.36, 2.68)	++
Gastrointestinal disorders	259	1.32 (1.16, 1.50)	+	2556	1.56 (1.50, 1.63)	+
Investigations	179	1.29 (1.11, 1.50)	+	1360	1.17 (1.10, 1.23)	+
renal and urinary disorders	60	1.28(0.99, 1.65)	+	160	0.42(0.36, 0.49)	-
cardiac disorders	58	1.16(0.9, 1.51)	+	194	0.4(0.35, 0.47)	-
Neoplasms benign, malignant and unspecified	67	1.08 (0.85, 1.38)	+	381	0.79 (0.71, 0.87)	-
Nervous system disorders	190	0.99 (0.86, 1.15)	-	2853	1.85 (1.78, 1.93)	+
General disorders and administration site conditions	383	0.86 (0.77, 0.96)	-	3206	0.86 (0.83, 0.89)	-
Skin and subcutaneous tissue disorders	117	0.84 (0.70, 1.01)	-	1941	1.81 (1.73, 1.90)	+
ear and labyrinth disorders	6	0.56(0.25, 1.26)	-	88	1.01(0.82, 1.24)	+
hepatobiliary disorders	7	0.35(0.17, 0.73)	-	186	1.08(0.94, 1.25)	+
Other SOCs with weaker or no signals			-			-