Table 4.
Treatment-related adverse events stratified by olaratumab concentration
| Olaratumab (Cmin1) | Olaratumab (Cavg) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dox | Overall | Q1 | Q2 | Q3 | Q4 | Dox | Overall | Q1 | Q2 | Q3 | Q4 | |
| n = 65 | n = 62 | n = 15 | n = 16 | n = 15 | n = 16 | n = 65 | n = 62 | n = 15 | n = 16 | n = 15 | n = 16 | |
| Cmin1 range (µg/mL) |
– | 12.3–188.1 | 12.3–<62.8 | 62.8–<86.9 | 86.9–<105.6 | 105.6–188.1 | – | 56.0–347.3 | 56.0–<134.4 | 134.4–<175.2 | 175.2–<249.9 | 249.9–347.3 |
| Overall TEAEs | ||||||||||||
| Grade ≤ 2, % | 19 (29.2) | 12 (19.4) | 1 (6.7) | 5 (31.3) | 3 (20.0) | 3 (18.8) | 19 (29.2) | 12 (19.4) | 1 (6.7) | 5 (31.3) | 1 (6.7) | 5 (31.3) |
| Grade > 2, % | 45 (69.2) | 49 (79.0) | 13 (86.7) | 11 (68.8) | 12 (80.0) | 13 (81.3) | 45 (69.2) | 49 (79.0) | 13 (86.7) | 11 (68.8) | 14 (93.3) | 11 (68.8) |
| Grade ≥ 4, % | 20 (30.8) | 25 (40.3) | 7 (46.7) | 5 (31.3) | 7 (46.7) | 6 (37.5) | 20 (30.8) | 25 (40.3) | 6 (40.0) | 8 (50.0) | 6 (40.0) | 5 (31.3) |
| Neutropenia | ||||||||||||
| Grade ≤ 2, %* | 3 (4.6) | 3 (4.8) | 0 | 2 (12.5) | 1 (6.7) | 0 | 3 (4.6) | 3 (4.8) | 0 | 2 (12.5) | 1 (6.7) | 0 |
| Grade > 2, %* | 22 (33.8) | 35 (56.5) | 9 (60.0) | 6 (37.5) | 11 (73.3) | 9 (56.3) | 22 (33.8) | 35 (56.5) | 9 (60.0) | 8 (50.0) | 11 (73.3) | 7 (43.8) |
| Grade ≥ 4, %* | 17 (26.2) | 23 (37.1) | 6 (40.0) | 5 (31.3) | 6 (40.0) | 6 (37.5) | 17 (26.2) | 23 (37.1) | 5 (33.3) | 7 (43.8) | 6 (40.0) | 5 (31.3) |
| Mucositis | ||||||||||||
| Grade ≤ 2, %* | 20 (30.8) | 32 (51.6) | 8 (53.3) | 6 (37.5) | 9 (60.0) | 9 (56.3) | 20 (30.8) | 32 (51.6) | 6 (40.0) | 8 (50.0) | 8 (53.3) | 10 (62.5) |
| Grade > 2, %* | 3 (4.6) | 2 (3.2) | 0 | 2 (12.5) | 0 | 0 | 3 (4.6) | 2 (3.2) | 0 | 2 (12.5) | 0 | 0 |
| Grade ≥ 4, %* | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Doxdoxorubicin, Q quartile, Cmin1 trough serum concentration at the end of Cycle 1, Cavg average concentration over patient’s entire treatment, TEAEs treatment-emergent adverse events