Safety profile
nausea, death, neutropenia, leukopenia, peripheral sensory neuropathy, gastrointestinal and hematologic adverse, treatment-emergent adverse, thrombocytopenia, vomiting, anemia, treatment-emergent adverse events, nausea and/or vomiting, alopecia, Cancer
ADVERSE EVENT, NEUTROPENIA, LEUKOPENIA, PERIPHERAL SENSORY NEUROPATHY, ADVERSE EVENTS, ADVERSE EVENT, THROMBOCYTOPENIA, ANEMIA, ADVERSE EVENT, ALOPECIA, CANCER
In both Japanese and non-Japanese subgroups, the median number of cycles of placebo/veliparib received was higher in the control arm compared with the veliparib-throughout arm (Japan, 25 [range, 7–36] versus 17 [2–36]; non-Japan, 18 [1–36] versus 15 [1–36]). The median number of cycles of carboplatin was six for both arms in both subgroups (Japan, range of 6–6 and 4–6 for control and veliparib-throughout, respectively; non-Japan, range of 1–6 for both arms), and the median number of cycles of paclitaxel was six for both arms in both subgroups (Japan, range of 6–6 and 4–6 for control and veliparib-throughout, respectively; non-Japan, range of 1–6 and 1–7, respectively).An overview of treatment-emergent adverse events is presented in Table Overview of treatment-emergent adverse events by MedDRA System Organ Class and preferred termsData include adverse events of any grade that occurred in ≥ 25% of the safety population (e.g., those who received at least one dose of study drug) of Japanese patients in either treatment arm and corresponding adverse events of grade 3 + . Adverse events were reported using preferred terms within a System Organ Class according to the Medical Dictionary for Regulatory Activities (MedDRA) and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03Common any grade adverse events with ≥ 10% higher rate in the veliparib-throughout versus control arm were nausea and thrombocytopenia (Japan and non-Japan subgroups), and anemia and vomiting (non-Japan subgroup only). Rates of alopecia and of peripheral sensory neuropathy were ≥ 10% higher in the control arm versus the veliparib-throughout arm in Japan subgroup only.In the veliparib-throughout arm, rates of any grade alopecia, nausea, neutropenia, and thrombocytopenia were > 10% higher in the Japanese subgroup compared with non-Japanese subgroup. Rates of grade 3/4 leukopenia and neutropenia were > 10% higher in the veliparib-throughout arm in the Japanese subgroup compared with the non-Japanese subgroup. Conversely, rates of any grade and grade 3/4 anemia were > 10% higher in the veliparib-throughout arm in the non-Japanese subgroup compared with the Japanese subgroup.The rate of treatment-emergent adverse events leading to veliparib discontinuation were comparable for patients in the veliparib-throughout arm in the Japanese (Rates of gastrointestinal and hematologic adverse events of special interest by treatment phase are described in Table Adverse events of special interest by treatment phaseData include adverse events of special interest that occurred in ≥ 25% of the safety population (e.g., those who received at least one dose of study drug) of Japanese patients in either treatment arm. Adverse events were reported using preferred terms within a System Organ Class according to the Medical Dictionary for Regulatory Activities (MedDRA) and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03For nausea and/or vomiting, antiemetics were used to prevent premature discontinuation of veliparib or to maintain quality of life. At the time of the interim database lock, metoclopramide (68%), olanzapine (56%), prochlorperazine (44%), and granisetron (40%) were frequently administered during veliparib monotherapy maintenance phase for Japanese patients in the veliparib-throughout arm (Table Antiemetic use during maintenance phase in Japan subgroup of veliparib-throughout armThere were no treatment-emergent adverse events leading to death in either treatment arm in the Japanese subgroup. In the non-Japanese subgroup, eight patients (2.3%) in the veliparib-throughout arm and six patients (1.7%) in the control arm had a treatment-emergent adverse event leading to death; none were considered related to veliparib/placebo by the investigator.