TABLE 3.
Summary of Treatment-Emergent Adverse Events in All Treated Patients
| Event | SG (n = 296), No. (%) | Docetaxel (n = 288), No. (%) | ||
|---|---|---|---|---|
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| TEAEsa,b | 295 (99.7) | 197 (66.6) | 282 (97.9) | 218 (75.7) |
| TEAEs reported in ≥10% in either groupc | ||||
| Fatigue | 168 (56.8) | 37 (12.5) | 161 (55.9) | 28 (9.7) |
| Diarrhea | 156 (52.7) | 31 (10.5) | 97 (33.7) | 11 (3.8) |
| Alopecia | 128 (43.2) | 2 (0.7) | 86 (29.9) | 2 (0.7) |
| Nausea | 123 (41.6) | 5 (1.7) | 75 (26.0) | 3 (1.0) |
| Anemia | 119 (40.2) | 19 (6.4) | 89 (30.9) | 17 (5.9) |
| Neutropenia | 111 (37.5) | 73 (24.7) | 123 (42.7) | 106 (36.8) |
| Constipation | 86 (29.1) | 0 | 49 (17.0) | 1 (0.3) |
| Decreased appetite | 78 (26.4) | 7 (2.4) | 69 (24.0) | 6 (2.1) |
| Vomiting | 62 (20.9) | 7 (2.4) | 43 (14.9) | 6 (2.1) |
| Cough | 46 (15.5) | 0 | 45 (15.6) | 1 (0.3) |
| Dyspnea | 42 (14.2) | 4 (1.4) | 51 (17.7) | 13 (4.5) |
| Stomatitis | 39 (13.2) | 3 (1.0) | 58 (20.1) | 7 (2.4) |
| Leukopenia | 38 (12.8) | 15 (5.1) | 63 (21.9) | 50 (17.4) |
| Pruritus | 37 (12.5) | 1 (0.3) | 11 (3.8) | 0 |
| Pyrexia | 37 (12.5) | 2 (0.7) | 34 (11.8) | 2 (0.7) |
| Back pain | 33 (11.1) | 2 (0.7) | 19 (6.6) | 2 (0.7) |
| Abdominal pain | 31 (10.5) | 3 (1.0) | 14 (4.9) | 0 |
| Arthralgia | 30 (10.1) | 2 (0.7) | 29 (10.1) | 1 (0.3) |
| Rash | 30 (10.1) | 0 | 19 (6.6) | 0 |
| Febrile neutropenia | 23 (7.8) | 23 (7.8) | 29 (10.1) | 27 (9.4) |
| Lymphopenia | 23 (7.8) | 9 (3.0) | 31 (10.8) | 12 (4.2) |
| Peripheral edema | 16 (5.4) | 0 | 35 (12.2) | 4 (1.4) |
| Dysgeusia | 14 (4.7) | 0 | 30 (10.4) | 0 |
| Peripheral neuropathy | 11 (3.7) | 0 | 38 (13.2) | 2 (0.7) |
| Treatment-relatedc | 279 (94.3) | 156 (52.7) | 262 (91.0) | 173 (60.1) |
| TEAEs leading to discontinuation | 29 (9.8) | 48 (16.7) | ||
| Treatment-relatedc | 20 (6.8) | 41 (14.2) | ||
| TEAEs leading to death | 10 (3.4) | 13 (4.5) | ||
| Treatment-relatedd | 4 (1.4) | 3 (1.0) | ||
| TEAEs leading to dose reduction | 87 (29.4) | 112 (38.9) | ||
| TEAEs leading to treatment interruption | 171 (57.8) | 81 (28.1) | ||
Abbreviations: AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SG, sacituzumab govitecan; TEAE, treatment-emergent adverse event.
TEAE is any AE with an onset date on or after the study drug start date and no later than 30 days after last dose of study drug.
Coded according to MedDRA version 26.1 and AE severity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events. Multiple AEs were counted only once per participant for the highest severity grade for each preferred term.
Determined by investigator.
Treatment-related TEAEs that led to death, investigator-assessed, included cardiac failure, cerebrovascular accident, death, febrile neutropenia, hematemesis, ischemic stroke, myocardial ischemia, neutropenic colitis, sepsis, and septic shock (one each) in the SG group and death (n = 4), pneumonia (n = 3), cardiac failure, acute respiratory failure, cardiorespiratory arrest, intestinal obstruction, pneumonitis, and respiratory failure (one each) in the docetaxel group.