Table 2.

Summary of AEs

AEsPlacebo BID and carbo/paclitaxel (N = 52)Veliparib BID and carbo/paclitaxel (N = 105)
Any grade AE, n (%)46 (89)101 (96)
Any grade ≥3 AE, n (%)30 (58)72 (69)
Any SAE12 (23)28 (27)
 Alopecia22 (42)41 (39)
 Neutropenia15 (29)38 (36)
 Anemia21 (40)33 (31)
 Nausea13 (25)29 (28)
 Peripheral neuropathy13 (25)25 (24)
 Fatigue13 (25)24 (23)
 Arthralgia7 (13)20 (19)
 Dyspnea6 (12)16 (15)
 Decreased appetite9 (17)14 (13)
 Diarrhea8 (15)13 (12)
 Thrombocytopenia8 (15)13 (12)
 Myalgia4 (8)13 (12)
 Pain6 (12)12 (11)
 Constipation7 (13)9 (9)
 Cough8 (15)8 (8)
Unbalanced AE, n (%)
 Leukopenia0 (0)12 (11)
Grade ≥3 AEs, n (%)
 Neutropenia12 (23)20 (19)
 Anemia5 (10)11 (10)
 Alopecia3 (6)7 (7)
 Leukopenia0 (0)6 (6)
 Thrombocytopenia3 (6)5 (5)
 Nausea0 (0)4 (4)
 Hyperkalemia1 (2)4 (4)
 Arthralgia0 (0)3 (3)
 Fatigue0 (0)3 (3)
 Hypersensitivity0 (0)3 (3)
 Hyponatremia1 (2)2 (2)
 Myalgia0 (0)2 (2)
 Weight loss0 (0)2 (2)
  • NOTE: Analyses of safety were performed using data from the 157 patients who received at least 1 dose of study drug. Toxicity of any grade occurring in ≥10% of patients and grade ≥3 occurring in >1 patient are reported.

  • Abbreviations: carbo, carboplatin; SAE, serious adverse event.