Table 2.

Treatment-emergent AEs (occurring in ≥20% of patients in part 1 or part 2A) by rucaparib dose

Part 1 (phase I dose escalation), n (%)Part 2A (phase II expansion), n (%)
40–500 mg QD (n = 26)a240 mg BID (n = 3)360 mg BID (n = 8)480 mg BID (n = 9)600mg BID (n = 7)840 mg BID (n = 3)All doses (n = 56)600 mg BID (n = 42)
Adverse eventAll gradeAll gradeAll gradeAll gradeAll gradeAll gradeAll gradeGrade 1Grade 2Grade 3Grade 4All grade
Any adverse event26 (100.0)3 (100.0)8 (100.0)8 (88.9)7 (100.0)3 (100.0)55 (98.2)0 (0)7 (16.7)26 (61.9)6 (14.3)42 (100.0)
Asthenia/fatigue10 (38.5)2 (66.7)5 (62.5)5 (55.6)5 (71.4)1 (33.3)28 (50.0)8 (19.0)17 (40.5)11 (26.2)0 (0)36 (85.7)
Nausea12 (46.2)0 (0)6 (75.0)4 (44.4)4 (57.1)3 (100.0)29 (51.8)17 (40.5)15 (35.7)3 (7.1)0 (0)35 (83.3)
Anemiab5 (19.2)0 (0)4 (50.0)3 (33.3)4 (57.1)1 (33.3)17 (30.4)7 (16.7)7 (16.7)13 (31.0)3 (7.1)30 (71.4)
AST/ALT increased2 (7.7)0 (0)2 (25.0)3 (33.3)6 (85.7)1 (33.3)14 (25.0)11 (26.2)7 (16.7)6 (14.3)0 (0)24 (57.1)
Vomiting10 (38.5)0 (0)3 (37.5)5 (55.6)4 (57.1)2 (66.7)24 (42.9)12 (28.6)8 (19.0)3 (7.1)0 (0)23 (54.8)
Constipation8 (30.8)0 (0)2 (25.0)2 (22.2)1 (14.3)0 (0)13 (23.2)15 (35.7)7 (16.7)0 (0)0 (0)22 (52.4)
Headache5 (19.2)0 (0)2 (25.0)1 (11.1)2 (28.6)1 (33.3)11 (19.6)13 (31.0)5 (11.9)1 (2.4)0 (0)19 (45.2)
Abdominal pain7 (26.9)0 (0)2 (25.0)3 (33.3)1 (14.3)1 (33.3)14 (25.0)8 (19.0)7 (16.7)3 (7.1)0 (0)18 (42.9)
Dysgeusia1 (3.8)1 (33.3)2 (25.0)1 (11.1)1 (14.3)2 (66.7)8 (14.3)11 (26.2)6 (14.3)0 (0)0 (0)17 (40.5)
Diarrhea4 (15.4)1 (33.3)1 (12.5)2 (22.2)2 (28.6)3 (100.0)13 (23.2)8 (19.0)8 (19.0)0 (0)0 (0)16 (38.1)
Thrombocytopeniac0 (0)0 (0)1 (12.5)2 (22.2)5 (71.4)0 (0)8 (14.3)8 (19.0)6 (14.3)1 (2.4)0 (0)15 (35.7)
Blood creatinine increased2 (7.7)1 (33.3)0 (0)1 (11.1)1 (14.3)0 (0)5 (8.9)9 (21.4)5 (11.9)0 (0)0 (0)14 (33.3)
Neutropeniad3 (11.5)0 (0)1 (12.5)3 (33.3)3 (42.9)0 (0)10 (17.9)4 (9.5)2 (4.8)4 (9.5)3 (7.1)13 (31.0)
Decreased appetite9 (34.6)2 (66.7)3 (37.5)1 (11.1)0 (0)1 (33.3)16 (28.6)6 (14.3)5 (11.9)1 (2.4)0 (0)12 (28.6)
Abdominal distension3 (11.5)0 (0)2 (25.0)2 (22.2)1 (14.3)0 (0)8 (14.3)6 (14.3)4 (9.5)0 (0)0 (0)10 (23.8)
Blood alkaline phosphatase increased2 (7.7)0 (0)0 (0)2 (22.2)4 (57.1)0 (0)8 (14.3)10 (23.8)0 (0)0 (0)0 (0)10 (23.8)
Dyspnea2 (7.7)0 (0)3 (37.5)3 (33.3)1 (14.3)1 (33.3)10 (17.9)8 (19.0)1 (2.4)1 (2.4)0 (0)10 (23.8)
Upper respiratory tract infection1 (3.8)0 (0)1 (12.5)0 (0)0 (0)0 (0)2 (3.6)6 (14.3)4 (9.5)0 (0)0 (0)10 (23.8)
Cough3 (11.5)1 (33.3)0 (0)3 (33.3)2 (28.6)2 (66.7)11 (19.6)7 (16.7)1 (2.4)1 (2.4)0 (0)9 (21.4)
Dizziness2 (7.7)1 (33.3)2 (25.0)2 (22.2)2 (28.6)0 (0)9 (16.1)7 (16.7)1 (2.4)1 (2.4)0 (0)9 (21.4)
  • NOTE: Table is sorted by decreasing incidence in part 2A patients.

  • Abbreviations: BID, twice daily; QD, once daily.

  • a40 mg QD (n = 6), 80 mg QD (n =3), 160 mg QD (n = 4), 300 mg QD (n = 9), and 500 mg QD (n = 4).

  • bAnemia and/or low/decreased hemoglobin.

  • cThrombocytopenia and/or low or decreased platelets.

  • dNeutropenia and/or low or decreased absolute neutrophil count.