Table 2.
TRAE1, n (%) | SG | TPC | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
<65 years (n = 209) | ≥65 years (n = 49) | <65 years (n = 176) | ≥65 years (n = 48) | |||||||||
All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | |
Hematologic | ||||||||||||
Neutropenia2 | 134 (64) | 76 (36) | 34 (16) | 29 (59) | 12 (24) | 10 (20) | 75 (43) | 30 (17) | 25 (14) | 21 (44) | 15 (31) | 4 (8) |
Anemia3 | 63 (30) | 13 (6) | 0 | 26 (53) | 7 (14) | 0 | 40 (23) | 8 (5) | 0 | 14 (29) | 3 (6) | 0 |
Leukopenia4 | 33 (16) | 19 (9) | 2 (1) | 8 (16) | 4 (8) | 1 (2) | 18 (10) | 8 (5) | 2 (1) | 7 (15) | 2 (4) | 0 |
Febrile neutropenia | 11 (5) | 10 (5) | 1 (<1) | 4 (8) | 2 (4) | 2 (4) | 5 (3) | 4 (2) | 1 (1) | 0 | 0 | 0 |
Gastrointestinal | ||||||||||||
Diarrhea | 121 (58) | 22 (11) | 0 | 32 (65) | 5 (10) | 0 | 20 (11) | 1 (1) | 0 | 7 (15) | 0 | 0 |
Nausea | 123 (59) | 6 (3) | 1 (<1) | 24 (49) | 0 | 0 | 48 (27) | 0 | 0 | 11 (23) | 1 (2) | 0 |
Constipation | 32 (15) | 0 | 0 | 12 (24) | 0 | 0 | 27 (15) | 0 | 0 | 5 (10) | 0 | 0 |
Vomiting | 63 (30) | 2 (1) | 1 (<1) | 12 (24) | 0 | 0 | 20 (11) | 0 | 0 | 3 (6) | 1 (2) | 0 |
Other | ||||||||||||
Fatigue | 91 (44) | 6 (3) | 0 | 24 (49) | 2 (4) | 0 | 49 (28) | 10 (6) | 0 | 19 (40) | 2 (4) | 0 |
Alopecia | 101 (48) | 0 | 0 | 18 (37) | 0 | 0 | 27 (15) | 0 | 0 | 8 (17) | 0 | 0 |
Decreased appetite | 40 (19) | 2 (1) | 0 | 11 (22) | 2 (4) | 0 | 25 (14) | 1 (1) | 0 | 7 (15) | 0 | 0 |
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.
1Patients may report more than 1 event per preferred term. AEs were coded using MedDRA v22.1, and AE severity was graded per NCI CTCAE v4.03.
2Combined preferred terms of “neutropenia” and “neutrophil count decreased.”
3Combined preferred terms of “anemia”, “hemoglobin decreased”, and “red blood cell count decreased.”
4Combined preferred terms of “leukopenia” and “white blood cell count decreased.”