Table 1.
Patient disposition from treatment during follow-up of SafeHER (ITT population)a.
| Patient follow-up | Overall N = 2573 | No chemotherapy n = 235 | Concurrent chemotherapy n = 1533 | Sequential chemotherapy n = 805 |
|---|---|---|---|---|
| Completed treatment according to protocol, n (%) | ||||
| Yes | 2319 (90.1) | 207 (88.1) | 1394 (90.9) | 718 (89.2) |
| No | 254 (9.9) | 28 (11.9) | 139 (9.1) | 87 (10.8) |
| Reason patient discontinued treatment, n (%) | ||||
| AEs | 130 (5.1) | 13 (5.1) | 73 (4.8) | 44 (5.5) |
| Withdrew consent | 36 (1.4) | 8 (3.4) | 15 (1.0) | 13 (1.6) |
| Disease progression/disease recurrence | 50 (1.9) | 3 (1.3) | 27 (1.8) | 20 (2.5) |
| Lack of compliance | 5 (0.2) | 0 | 2 (0.1) | 3 (0.4) |
| Otherb | 33 (1.3) | 4 (1.7) | 22 (1.4) | 7 (0.9) |
AE, adverse event; ITT, intent-to-treat.
a
Percentages are based on the overall number of patients in each group.
b
Other includes pregnancy, investigator/sponsor decision, protocol violations, failure of inclusion criteria, and immobility.