Table 3.
Adverse events reported in ≥15% of patients in either treatment group.
| Niraparib (N = 134) | Physician's choice (N = 65) | |||||
|---|---|---|---|---|---|---|
| Any grade | Grade 1–2 | Grade ≥ 3 | Any grade | Grade 1–2 | Grade ≥ 3 | |
| Hematologya | ||||||
| Anemia | 121 (90.3) | 60 (44.8) | 61 (45.5) | 50 (76.9) | 48 (73.8) | 2 (3.1) |
| Lymphopenia | 106 (79.1) | 63 (47.0) | 30 (22.4) | 39 (60.0) | 27 (41.5) | 6 (9.2) |
| WBC count | 104 (77.6) | 89 (66.4) | 15 (11.2) | 46 (70.8) | 35 (53.8) | 11 (16.9) |
| Thrombocytopenia | 96 (71.6) | 49 (36.6) | 47 (35.1) | 16 (24.6) | 16 (24.6) | 0 (0.0) |
| Neutropenia | 85 (63.4) | 49 (36.6) | 29 (21.6) | 37 (56.9) | 19 (29.2) | 15 (23.1) |
| Biochemistrya | ||||||
| LDH abnormalityb | 96 (71.6) | — | — | 51 (78.5) | — | — |
| GGT | 79 (59.0) | 53 (39.6) | 26 (19.4) | 35 (53.8) | 27 (41.5) | 8 (12.3) |
| Hyperglycemia | 75 (56.0) | 73 (54.5) | 1 (0.7) | 36 (55.4) | 34 (52.3) | 2 (3.1) |
| Alkaline phosphatase | 74 (55.2) | 66 (49.3) | 8 (6.0) | 34 (52.3) | 33 (50.8) | 1 (1.5) |
| SGOT | 63 (47.0) | 62 (46.3) | 1 (0.7) | 35 (53.8) | 35 (53.8) | 0 (0.0) |
| SGPT | 55 (41.0) | 52 (38.8) | 3 (2.2) | 31 (47.7) | 29 (44.6) | 2 (3.1) |
| Hypocalcemia | 35 (26.1) | 34 (25.4) | 1 (0.7) | 8 (12.3) | 8 (12.3) | 0 (0.0) |
| Hyponatremia | 31 (23.1) | 27 (20.1) | 4 (3.0) | 8 (12.3) | 7 (10.8) | 1 (1.5) |
| Hypoalbuminemia | 30 (22.4) | 28 (20.9) | 1 (0.7) | 12 (18.5) | 12 (18.5) | 0 (0.0) |
| BUN abnormalityb | 25 (18.7) | — | — | 15 (23.1) | — | — |
| Serum creatinine | 23 (17.2) | 23 (17.2) | 0 (0.0) | 11 (16.9) | 11 (16.9) | 0 (0.0) |
| Other adverse events | ||||||
| Nausea | 79 (59.0) | 76 (56.7) | 3 (2.2) | 19 (29.2) | 18 (27.7) | 1 (1.5) |
| Fatigue | 73 (54.5) | 62 (46.3) | 11 (8.2) | 34 (52.3) | 30 (46.2) | 4 (6.2) |
| Weight loss | 53 (39.6) | 53 (39.6) | 0 (0.0) | 10 (15.4) | 10 (15.4) | 0 (0.0) |
| Vomiting | 50 (37.3) | 46 (34.3) | 4 (3.0) | 10 (15.4) | 10 (15.4) | 0 (0.0) |
| Constipation | 49 (36.6) | 48 (35.8) | 1 (0.7) | 11 (16.9) | 11 (16.9) | 0 (0.0) |
| Headache | 44 (32.8) | 40 (29.9) | 4 (3.0) | 10 (15.4) | 10 (15.4) | 0 (0.0) |
| Anorexia | 41 (30.6) | 39 (29.1) | 2 (1.5) | 7 (10.8) | 6 (9.2) | 1 (1.5) |
| Dizziness | 29 (21.6) | 26 (19.4) | 3 (2.2) | 6 (9.2) | 6 (9.2) | 0 (0.0) |
| Back pain | 29 (21.6) | 27 (20.1) | 2 (1.5) | 8 (12.3) | 7 (10.8) | 1 (1.5) |
| Dyspnea | 27 (20.1) | 24 (17.9) | 3 (2.2) | 8 (12.3) | 8 (12.3) | 0 (0.0) |
| Insomnia | 23 (17.2) | 23 (17.2) | 0 (0.0) | 5 (7.7) | 4 (6.2) | 1 (1.5) |
| Pain in extremity | 23 (17.2) | 21 (15.7) | 2 (1.5) | 7 (10.8) | 6 (9.2) | 1 (1.5) |
| Mucositis oral | 22 (16.4) | 22 (16.4) | 0 (0.0) | 10 (15.4) | 10 (15.4) | 0 (0.0) |
| Abdominal pain | 22 (16.4) | 19 (14.2) | 3 (2.2) | 13 (20.0) | 11 (16.9) | 2 (3.1) |
| Diarrhea | 21 (15.7) | 20 (14.9) | 1 (0.7) | 21 (32.3) | 21 (32.3) | 0 (0.0) |
| Paresthesia | 7 (5.2) | 7 (5.2) | 0 (0.0) | 10 (15.4) | 10 (15.4) | 0 (0.0) |
| Palmar-Plantar erythrodysesthesia syndrome | 0 (0.0) | 0 (0.0) | 0 (0.0) | 15 (23.1) | 13 (20.0) | 2 (3.1) |
Note: The analysis population was the safety population defined as all randomized patients who received at least one dose of treatment. Grading according to CTCAE version 4.0.
Abbreviations: BUN, blood urea nitrogen; GGT, gamma-glutamyl transferase; LDH, lactate dehydrogenase; SGOT, serum glutamic oxaloacetic transaminase; SGPT, serum glutamic pyruvic transaminase; WBC, white blood cell.
aHematology and biochemistry abnormalities events were identified in the corresponding laboratory forms. For some hematology and biochemistry tests, to distinguish between grade 0 and 1, normal values were required. In case of missing normal values, CTCAE grade was defined as grade 0/1 and these events were included in the “any grade” count.
bPresented as “above upper limit of normal.”