Table 2.
Patient disposition
| No. (%) of Patients | |||
|---|---|---|---|
| Olaratumab + Liposomal Doxorubicin | Liposomal Doxorubicin | Total | |
| mITT population | 62 | 61 | 123 |
| Treated | 62 (100.0) | 61 (100.0) | 123 (100.0) |
| On treatmenta | 1 (1.6) | 0 | 1 (0.8) |
| Off treatment | 61 (98.4) | 61 (100.0) | 122 (99.2) |
| Reasons for discontinuation of study therapy | |||
| Adverse event | 2 (3.2) | 7 (11.5) | 9 (7.3) |
| Death | 2 (3.2) | 0 | 2 (1.6) |
| PD per RECIST | 42 (67.7) | 12 (19.7) | 54 (43.9) |
| PD, symptomatic deterioration | 10 (16.1) | 8 (13.1) | 18 (14.6) |
| Withdrawal by patient | 1 (1.6) | 3 (4.9) | 4 (3.3) |
| Lost to follow-up | 1 (1.6) | 0 | 1 (0.8) |
| Other | 3 (4.8) | 3 (4.9) | 6 (4.9) |
| Reasons for discontinuation for patients electing to receive olaratumab monotherapy after progression on liposomal doxorubicin | |||
| PD per RECIST | 0 | 26 (42.6) | 26 (21.1) |
| PD, symptomatic deterioration | 0 | 2 (3.3) | 2 (1.6) |
| On studya | 1 (1.6) | 1 (1.6) | 2 (1.6) |
| Off study | 61 (98.4) | 60 (98.4) | 121 (98.4) |
mITT, modified intent-to-treat; PD, progressive disease; RECIST, Response Evaluation Criteria in Solid Tumors.aRefers to those who were still on study therapy or on study evaluations as of cutoff date. For patient who discontinued study therapy for reasons other than PD, radiological scans continued until a documented PD. After PD was documented, patient was considered off study. Patients were followed for survival status. In any study phase, patients could withdraw consent or become lost to follow-up