Table 2B.

The modified Wegener’s Granulomatosis Etanercept Trial: definitions.

Term	Definition
Limited disease	A patient who does not have disease that poses an immediate threat to either a critical individual organ or to the patient’s life. Specifically, this means: Patient has no red blood cells in the urine. Serum creatinine is normal. Pulmonary involvement must be circumscribed, such that supplemental oxygen therapy is not required. No disease may exist within any other critical organ (e.g., gastrointestinal tract, eyes, central nervous system) that, without the immediate institution of maximal therapy (i.e., pulse methylprednisolone and daily cyclophosphamide), threatens the function of that organ and/or the patient’s life.
Severe disease	Any patient with WG whose disease is not classifiable as limited has, by definition, severe disease.

Term

Definition

Limited disease

A patient who does not have disease that poses an immediate threat to either a critical individual organ or to the patient’s life. Specifically, this means:

Patient has no red blood cells in the urine.
Serum creatinine is normal.
Pulmonary involvement must be circumscribed, such that supplemental oxygen therapy is not required.

No disease may exist within any other critical organ (e.g., gastrointestinal tract, eyes, central nervous system) that, without the immediate institution of maximal therapy (i.e., pulse methylprednisolone and daily cyclophosphamide), threatens the function of that organ and/or the patient’s life.

Severe disease

Any patient with WG whose disease is not classifiable as limited has, by definition, severe disease.