Table 3 Nonhaematological toxicities (worst grade per patient)

From: Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer

Adverse event

Dose level (mg m−2)

Grade 1

Grade 2

Grade 3

Grade 4

Nausea

5

0

0

0

NA

 

10

0

0

0

NA

 

20

0

1

0

NA

 

35

0

4

0

NA

 

50

2

2

1

NA

 

70

3

2

0

NA

 

90

0

1

0

NA

Stomatitis

5

0

0

0

0

 

10

0

0

0

0

 

20

0

0

0

0

 

35

2

1

0

0

 

50

1

1

0

0

 

70

1

3

1

0

 

90

0

1

1

0

Vomiting

5

0

0

0

0

 

10

0

0

0

0

 

20

0

0

0

0

 

35

1

1

1

0

 

50

3

0

0

0

 

70

1

3

0

0

 

90

1

1

0

0

Reduction in LVEF

5

0

0

0

0

 

10

0

0

0

0

 

20

0

0

0

0

 

35

1

1

0

0

 

50

0

0

0

0

 

70

1

3

0

0

 

90

0

0

0

0

Fatigue

5

0

0

0

0

 

10

0

0

0

0

 

20

0

0

0

0

 

35

0

1

0

0

 

50

0

2

1

0

 

70

2

4

0

0

 

90

2

1

0

0

Alopecia

5

0

0

 

10

0

0

 

20

0

0

 

35

2

1

 

50

3

1

 

70

1

4

 

90

2

0

Bilirubin

5

0

0

0

0

 

10

0

0

0

0

 

20

0

0

0

0

 

35

0

0

0

0

 

50

1

0

0

0

 

70

0

1

0

0

 

90

1

0

0

0

AST/ALT

5

0

0

0

0

 

10

0

0

0

0

 

20

0

0

0

0

 

35

1

0

0

0

 

50

1

1

0

0

 

70

1

0

0

0

 

90

1

1

0

0

  1. NA=not applicable. ALT=alanine aminotransferase; AST=aspartate aminotransferase; LVEF=left ventricular ejection fraction.