The most common treatment-related adverse events experienced by ≥10% of patients (ITT population).
| Number (%) of patients by preferred terma . | Talazoparib (N = 61) . | ||||
|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | |
| Any adverse event | 22 (36.1) | 9 (14.8) | 26 (42.6) | 1 (1.6) | 58 (95.1) |
| Fatigue | 34 (55.7) | 12 (19.7) | 1 (1.6) | 0 | 47 (77.0) |
| Nausea | 31 (50.8) | 7 (11.5) | 1 (1.6) | 0 | 39 (63.9) |
| Alopecia | 33 (54.1) | 2 (3.3) | 0 | 0 | 35 (57.4) |
| Anemia | 4 (6.6) | 1 (1.6) | 24 (39.3) | 0 | 29 (47.5) |
| Headache | 16 (26.2) | 2 (3.3) | 1 (1.6) | 0 | 19 (31.1) |
| Dizziness | 11 (18.0) | 1 (1.6) | 0 | 0 | 12 (19.7) |
| Constipation | 9 (14.8) | 2 (3.3) | 0 | 0 | 11 (18.0) |
| Neutrophil count decreased | 1 (1.6) | 2 (3.3) | 5 (8.2) | 1 (1.6) | 9 (14.8) |
| White blood cell count decreased | 5 (8.2) | 3 (4.9) | 1 (1.6) | 0 | 9 (14.8) |
| Decreased appetite | 7 (11.5) | 1 (1.6) | 0 | 0 | 8 (13.1) |
| Diarrhea | 6 (9.8) | 2 (3.3) | 0 | 0 | 8 (13.1) |
| Number (%) of patients by preferred terma . | Talazoparib (N = 61) . | ||||
|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | |
| Any adverse event | 22 (36.1) | 9 (14.8) | 26 (42.6) | 1 (1.6) | 58 (95.1) |
| Fatigue | 34 (55.7) | 12 (19.7) | 1 (1.6) | 0 | 47 (77.0) |
| Nausea | 31 (50.8) | 7 (11.5) | 1 (1.6) | 0 | 39 (63.9) |
| Alopecia | 33 (54.1) | 2 (3.3) | 0 | 0 | 35 (57.4) |
| Anemia | 4 (6.6) | 1 (1.6) | 24 (39.3) | 0 | 29 (47.5) |
| Headache | 16 (26.2) | 2 (3.3) | 1 (1.6) | 0 | 19 (31.1) |
| Dizziness | 11 (18.0) | 1 (1.6) | 0 | 0 | 12 (19.7) |
| Constipation | 9 (14.8) | 2 (3.3) | 0 | 0 | 11 (18.0) |
| Neutrophil count decreased | 1 (1.6) | 2 (3.3) | 5 (8.2) | 1 (1.6) | 9 (14.8) |
| White blood cell count decreased | 5 (8.2) | 3 (4.9) | 1 (1.6) | 0 | 9 (14.8) |
| Decreased appetite | 7 (11.5) | 1 (1.6) | 0 | 0 | 8 (13.1) |
| Diarrhea | 6 (9.8) | 2 (3.3) | 0 | 0 | 8 (13.1) |
Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; ITT, intent-to-treat; MedDRA, Medical Dictionary for Regulatory Activities; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.
aIncludes all data collected since the first dose of study drug. If the same patient had more than 1 occurrence in the same preferred term event category, only the occurrence with maximum CTCAE grade is counted. Patients are counted only once per event. MedDRA v23.1 coding dictionary applied. NCI-CTCAE version 4.03.
The most common treatment-related adverse events experienced by ≥10% of patients (ITT population).
| Number (%) of patients by preferred terma . | Talazoparib (N = 61) . | ||||
|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | |
| Any adverse event | 22 (36.1) | 9 (14.8) | 26 (42.6) | 1 (1.6) | 58 (95.1) |
| Fatigue | 34 (55.7) | 12 (19.7) | 1 (1.6) | 0 | 47 (77.0) |
| Nausea | 31 (50.8) | 7 (11.5) | 1 (1.6) | 0 | 39 (63.9) |
| Alopecia | 33 (54.1) | 2 (3.3) | 0 | 0 | 35 (57.4) |
| Anemia | 4 (6.6) | 1 (1.6) | 24 (39.3) | 0 | 29 (47.5) |
| Headache | 16 (26.2) | 2 (3.3) | 1 (1.6) | 0 | 19 (31.1) |
| Dizziness | 11 (18.0) | 1 (1.6) | 0 | 0 | 12 (19.7) |
| Constipation | 9 (14.8) | 2 (3.3) | 0 | 0 | 11 (18.0) |
| Neutrophil count decreased | 1 (1.6) | 2 (3.3) | 5 (8.2) | 1 (1.6) | 9 (14.8) |
| White blood cell count decreased | 5 (8.2) | 3 (4.9) | 1 (1.6) | 0 | 9 (14.8) |
| Decreased appetite | 7 (11.5) | 1 (1.6) | 0 | 0 | 8 (13.1) |
| Diarrhea | 6 (9.8) | 2 (3.3) | 0 | 0 | 8 (13.1) |
| Number (%) of patients by preferred terma . | Talazoparib (N = 61) . | ||||
|---|---|---|---|---|---|
| Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Total . | |
| Any adverse event | 22 (36.1) | 9 (14.8) | 26 (42.6) | 1 (1.6) | 58 (95.1) |
| Fatigue | 34 (55.7) | 12 (19.7) | 1 (1.6) | 0 | 47 (77.0) |
| Nausea | 31 (50.8) | 7 (11.5) | 1 (1.6) | 0 | 39 (63.9) |
| Alopecia | 33 (54.1) | 2 (3.3) | 0 | 0 | 35 (57.4) |
| Anemia | 4 (6.6) | 1 (1.6) | 24 (39.3) | 0 | 29 (47.5) |
| Headache | 16 (26.2) | 2 (3.3) | 1 (1.6) | 0 | 19 (31.1) |
| Dizziness | 11 (18.0) | 1 (1.6) | 0 | 0 | 12 (19.7) |
| Constipation | 9 (14.8) | 2 (3.3) | 0 | 0 | 11 (18.0) |
| Neutrophil count decreased | 1 (1.6) | 2 (3.3) | 5 (8.2) | 1 (1.6) | 9 (14.8) |
| White blood cell count decreased | 5 (8.2) | 3 (4.9) | 1 (1.6) | 0 | 9 (14.8) |
| Decreased appetite | 7 (11.5) | 1 (1.6) | 0 | 0 | 8 (13.1) |
| Diarrhea | 6 (9.8) | 2 (3.3) | 0 | 0 | 8 (13.1) |
Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; ITT, intent-to-treat; MedDRA, Medical Dictionary for Regulatory Activities; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.
aIncludes all data collected since the first dose of study drug. If the same patient had more than 1 occurrence in the same preferred term event category, only the occurrence with maximum CTCAE grade is counted. Patients are counted only once per event. MedDRA v23.1 coding dictionary applied. NCI-CTCAE version 4.03.
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