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Table 2 Dose intensity, Grade 3/4 adverse events and objective tumor responses.

From: Phase I/II open-label study of the biologic effects of the interleukin-2 immunocytokine EMD 273063 (hu14.18-IL2) in patients with metastatic malignant melanoma

ID Number

Number of Completed Cycles

Total Cumulative

Dose (mg)

Grade 3/4 Adverse Events

Objective Response

0001–1103

2

46.8

None

PD

0002–2101

1

23.7

None

PD

0002–2102

2

17.0

ALP NOS increased

Amylase increased

Lipase increased

Liver function tests NOS increased

PD

0003–3101

2

54.0

None

PD

0003–3102

2

45.1

Ureteric obstruction

PD

0004–4101

4

115.2

Pyrexia

Rigors

Hyponatremia

Hypoxia

SD × 4 mo.

0004–4102

2

42.7

Pyrexia

Rigors

PD

0004–4103

2

43.6

ALT increased

Hypokalemia

Rash NOS

PD

0004–4104

4

85.4

Arthralgia

Rigors

SD × 4 mo.

  1. PD = progressive disease. SD = stable disease. ALP = alkaline phosphatase. NOS = not otherwise specified. ALT = alanine aminotransferase.