Table 2.
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. |