Table 3.

Numbers of patients with elevated creatinine levels, stratified by toxicity grade and age, in study C97-1248

Toxicity gradea	Subjects with elevated creatinine levels (n)
	Adults (aged ≥16 years; n = 176)		Children (aged <16 years; n = 73)
	P188-P	Placebo	P188-P	Placebo
1	46	49	18	14
2	12	9	5	3
3	1	0	0	1
4	0	0	0	0

P188-P purified poloxamer 188

^a Toxicity grades according to the National Cancer Institute Common Toxicity Criteria, Version 1 [36]