Table 2 General dose reduction guidelines

Grade I

Continue study treatment at same dose; monitor and treat as clinically indicated.

Grade II

Continue study treatment at same dose; monitor and treat as clinically indicated.

Grade III

Step 1. Interrupt study drug until toxicity reduced to ≤Grade 1.

Step 2. Restart study treatment at same dose or lower dose at discretion of investigator

Grade IV

Step 1. Interrupt study drug until toxicity reduced to ≤Grade 2.

Step 2. Restart study treatment at lower dose level.