Table 5.

Adverse events and treatment schedule of thalidomide

Adverse event		No. patients (n = 61)	Mean daily dose (mg/day)		Plasma concentration (mg/L) †		Total dose (g)		Duration (months)
			Mean (range)	P‐value	Median (range)	P‐value	Median (range)	P‐value	Median (range)	P‐value
Peripheral neuropathy	+	34	214.0 (29.6–393.2)	ns	2.2 (0.7–5.7)	ns	49.7 (2.0–394.4)	P < 0.001	27.5 (1–196)	P < 0.001
	–	27	200.0 (76.2–378.8)		2.1 (0.4–6.0)		5.6 (0.4–96.4)		5 (1–71)
Somnolence	+	48	207.9 (29.6–393.2)	ns	2.2 (0.4–5.7)	ns	22.7 (0.4–394.4)	ns	14.5 (1–196)	ns
	–	13	193.1 (76.2–333.0)		2.0 (0.5–6.0)		10.6 (0.4–194.8)		8 (1–140)
Constipation	+	35	204.9 (62.4–393.2)	ns	2.4 (0.6–5.7)	ns	39.3 (0.4–394.4)	P = 0.001	26 (1–196)	P < 0.001
	–	26	206.5 (29.6–390.8)		1.8 (0.4–6.0)		7.7 (0.4–59.8)		6 (1–75)
Skin rash	+	33	204.9 (62.4–393.2)	ns	1.6 (0.4–5.7)	ns	23.0 (3.0–394.4)	ns	17 (3–196)	P = 0.041
	–	28	213.5 (29.6–390.8)		2.6 (0.6–6.0)		11.8 (0.4–262.3)		10 (1–113)
Dry mouth	+	34	219.9 (29.6–393.2)	ns	2.3 (0.4–5.7)	ns	32.6 (3.8–394.4)	P = 0.003	22.5 (3–196)	P < 0.001
	–	27	200.0 (76.2–378.8)		2.1 (0.5–6.0)		11.2 (0.4–96.4)		8 (1–71)
Neutropenia	+	15	206.3 (95.4–390.8)	ns	1.4 (1.0–4.2)	ns	28.0 (0.4–194.8)	ns	14 (1–140)	ns
	–	46	205.8 (29.6–393.2)		2.5 (0.4–6.0)		16.0 (1.6–394.4)		13.5 (1–96)
Fever	+	20	200.0 (29.6–331.6)	ns	2.6 (0.5–6.0)	ns	10.5 (0.4–394.4)	ns	15 (1–196)	ns
	–	41	219.0 (62.4–393.2)		2.2 (0.4–5.1)		18.6 (0.4–208.8)		14 (1–150)

The relationship between adverse events and treatment schedule was evaluated by the Mann–Whitney test. P < 0.05 was considered to be statistically significant. ns, not significant.

^† Plasma concentrations of thalidomide were available and examined in 47 cases.