Attributes | Factor levels | ||||
---|---|---|---|---|---|
Level 1 | Level 2 | Level 3 | Level 4 | ||
1. | Ability to self-care | No assistance required for activities of daily living | Little assistance required for activities of daily living | A lot of assistance required for activities of daily living | Complete assistance required for activities of daily living; bed-ridden |
2. | Treatment tolerability (adverse reactions) | No or mild adverse reactions possible; no hospitalization required | Moderate adverse reactions possible; manageable without hospitalization | Severe adverse reactions possible; hospitalization for 3–4 days may be required | Very severe to life-threatening adverse reactions possible; hospitalization for ≥5 days may be required |
3. | Survival benefit (vs. standard of care) | No additional survival benefit | Survival benefit of approximately 1 additional month | Survival benefit of approximately 2 additional months | Survival benefit of approximately 3 additional months |