Table 2.
Treatment-related adverse events (all grade, >20%; grade 3/4, >5% of patients) in the second-line subgroup.
| SG (n = 33) | TPC (n = 33) | |||||
|---|---|---|---|---|---|---|
| TRAEa—no. (%) | All grade | Grade 3 | Grade 4 | All grade | Grade 3 | Grade 4 |
| Hematologic | ||||||
| Neutropeniab | 25 (76) | 13 (39) | 7 (21) | 8 (24) | 5 (15) | 2 (6) |
| Anemiac | 13 (39) | 1 (3) | 0 | 7 (21) | 2 (6) | 0 |
| Leukopeniad | 5 (15) | 3 (9) | 0 | 2 (6) | 0 | 0 |
| Gastrointestinal | ||||||
| Diarrhea | 19 (58) | 2 (6) | 0 | 2 (6) | 0 | 0 |
| Nausea | 17 (52) | 0 | 0 | 8 (24) | 0 | 0 |
| Vomiting | 12 (36) | 0 | 0 | 2 (6) | 0 | 0 |
| Constipation | 9 (27) | 0 | 0 | 3 (9) | 0 | 0 |
| Other | ||||||
| Alopecia | 23 (70) | 0 | 0 | 4 (12) | 0 | 0 |
| Fatigue | 11 (33) | 1 (3) | 0 | 8 (24) | 0 | 0 |
Assessed in the safety population of patients who received ≥1 dose of study treatment.
Second-line patients were defined as those who received one line of therapy in the metastatic setting and recurred ≤12 months after (neo)adjuvant chemotherapy, prior to study enrollment.
AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, NCI CTCAE National Cancer Institute Common Terminology Criteria for AE, SG sacituzumab govitecan, TPC treatment of physician’s choice, TRAE treatment-related AE.
aPatients may report more than one event per preferred term. AEs were coded using MedDRA v22.1, and AE severity was graded per NCI CTCAE v4.03.
bCombined preferred terms of ‘neutropenia’ and ‘neutrophil count decreased’.
cCombined preferred terms of ‘anemia’, ‘hemoglobin decreased’, and ‘red blood cell count decreased’.
dCombined preferred terms of ‘leukopenia’ and ‘white blood cell count decreased’.