Table 1.
Recently diagnosed patients (≤3 years) | Chronic patients (>3 years) | |
---|---|---|
Patients enrolled (n) | 234 | 361 |
ITT population* (n) | 233 | 360 |
↓ | ↓ | |
Most common reasons for early study discontinuation (≥2% in any group) (%) | ||
Withdrawal of consent | 6.4 | 12.5 |
Lost to follow-up | 3.9 | 2.8 |
Adverse event | 3.4 | 7.8 |
Lack of efficacy | 3.0 | 2.2 |
*Patients who received at least one dose of study drug.
ITT: Intent-to-treat.