Table 2. Protocol violations.
Three main type of protocol violations occurred during the FU period; 1) patients with prolonged FU intervals (PV-1); 2) patients with USLs that were left untreated (PV-2); and 3) patients with inadequate FU after retreatment for recurrent ESCN (PV-3). Each PV could occur multiple times in a single patient.
| Number of patients (%) | Median frequency of occurrence per patient (range) | |
|---|---|---|
| Prolonged FU intervals (PV-1) | 24 (31%) | 1 (1–3) |
| USLs that were left untreated (PV-2) | 30 (38%) | 1 (1–4) |
| Inadequate FU after new ESCN (PV-3) | 4 (5%) | 1 (1–3) |
| Any violation | 46 (59%) | 1 (1–4) |