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) |