Table 3.
Adverse Events.
| TALA (n = 286) | Overall PCT (n = 126) | |||||||
|---|---|---|---|---|---|---|---|---|
| Any adverse event (AE), No. (%) | 282 (98.6) | 123 (97.6) | ||||||
| Seriousa | 91 (31.8) | 37 (29.4) | ||||||
| Serious and drug related | 26 (9.1) | 11 (8.7) | ||||||
| Grade 3 or 4 serious | 73 (25.5) | 32 (25.4) | ||||||
| Resulting in permanent drug discontinuation | 17 (5.9) | 11 (8.7) | ||||||
| Grade 3 | Grade 4 | Grade 3 | Grade 4 | |||||
| Hematologic b | ||||||||
| Patients with ≥1 hematologic AE, No. (%) | 140 (49.0) | 17 (5.9) | 29 (23.0) | 19 (15.1) | ||||
| Anemia | 110 (38.5) | 2 (0.7) | 5 (4.0) | 1 (0.8) | ||||
| Neutropenia | 51 (17.8) | 9 (3.1) | 25 (19.8) | 19 (15.1) | ||||
| Thrombocytopenia | 32 (11.2) | 10 (3.5) | 2 (1.6) | 0 | ||||
| Leukopenia | 18 (6.3) | 1 (0.3) | 8 (6.3) | 3 (2.4) | ||||
| Lymphopenia | 9 (3.1) | 0 | 0 | 1 (0.8) | ||||
| Febrile neutropenia | 0 | 1 (0.3) | 0 | 1 (0.8) | ||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Nonhematologic c | ||||||||
| Patients with ≥1 nonhematologic AE, No. (%) | 91 (31.8) | 48 (38.1) | ||||||
| Fatigue | 84 (29.4) | 55 (19.2) | 5 (1.7) | 0 | 33 (26.2) | 17 (13.5) | 4 (3.2) | 0 |
| Nausea | 97 (33.9) | 41 (14.3) | 1 (0.3) | 0 | 34 (27.0) | 23 (18.3) | 2 (1.6) | 0 |
| Headache | 66 (23.1) | 22 (7.7) | 5 (1.7) | 0 | 20 (15.9) | 7 (5.6) | 1 (0.8) | 0 |
| Alopecia | 65 (22.7) | 7 (2.4) | 0 | 0 | 25 (19.8) | 10 (7.9) | 0 | 0 |
| Vomiting | 45 (15.7) | 19 (6.6) | 7 (2.4) | 0 | 14 (11.1) | 13 (10.3) | 2 (1.6) | 0 |
| Diarrhea | 50 (17.5) | 11 (3.8) | 2 (0.7) | 0 | 14 (11.1) | 12 (9.5) | 7 (5.6) | 0 |
| Constipation | 44 (15.4) | 18 (6.3) | 1 (0.3) | 0 | 16 (12.7) | 11 (8.7) | 0 | 0 |
| Decreased appetite | 44 (15.4) | 16 (5.6) | 1 (0.3) | 0 | 19 (15.1) | 8 (6.3) | 1 (0.8) | 0 |
| Back pain | 36 (12.6) | 17 (5.9) | 7 (2.4) | 0 | 12 (9.5) | 6 (4.8) | 2 (1.6) | 0 |
| Dyspnea | 28 (9.8) | 15 (5.2) | 7 (2.4) | 0 | 12 (9.5) | 4 (3.2) | 3 (2.4) | 0 |
| Palmar-plantar erythrodysesthesia syndrome | 3 (1.0) | 0 | 1 (0.3) | 0 | 12 (9.5) | 13 (10.3) | 3 (2.4) | 0 |
| Pleural effusion | 0 | 1 (0.3) | 5 (1.7) | 0 | 1 (0.8) | 5 (4.0) | 5 (4.0) | 0 |
PCT = physician’s choice of therapy; TALA = talazoparib; Data are No. (%). AE grades are evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Patients with multiple AEs are counted once for each preferred term, system organ class, and overall. AEs with action taken of permanent discontinuation are taken from the AE electronic case report form.
“Serious” defined as any AE that results in death, is considered life-threatening or medically important, results in hospitalization/prolonged hospitalization or persistent/significant disability/incapacity, or is a congenital anomaly/birth defect.
The category of thrombocytopenia incudes reports of thrombocytopenia and decreased platelet count. The category of neutropenia includes reports of neutropenia, decreased neutrophil count, and neutropenic sepsis. The category of anemia includes reports of anemia and decreased hemoglobin. No cases of acute myeloid leukemia/myelodysplastic syndrome were reported in the talazoparib arm; 1 case was reported for a patient receiving capecitabine.
All AEs in ≥20% of patients or grade 3–4 AEs in ≥2.4% of patients. For these selected toxicities, no grade 4 AEs were reported in either arm.