cal trials, HALAVEN has been administered to 1963 patients including 467 patients exposed to HALAVEN for 6 months or longer. The majority of the 1963 patients were women (92%) with a median age of 55 years (range: 17 to 85 years). The racial and ethnic distribution was White (72%), Black (4%), Asian (9%), and other (3%).
Metastatic Breast Cancer
The most common adverse reactions (≥25%) reported in patients receiving HALAVEN were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation. The most common serious adverse reactions reported in patients receiving HALAVEN were febrile neutropenia (4%) and neutropenia (2%). The most common adverse reaction resulting in discontinuation of HALAVEN was peripheral neuropathy (5%).
The adverse reactions described in Table 2 were identified in 750 patients treated in Study 1 [see Clinical Studies (14.1)]. In Study 1, patients were randomized (2:1) to receive either HALAVEN (1.4 mg/m2 on Days 1 and 8 of a 21-day cycle) or single agent treatment chosen by their physician (control group). A total of 503 patients received HALAVEN and 247 patients in the control group received therapy consisting of chemotherapy [total 97% (anthracyclines 10%, capecitabine 18%, gemcitabine 19%, taxanes 15%, vinorelbine 25%, other chemotherapies 10%)] or hormonal therapy (3%). The median duration of exposure was 118 days for patients receiving HALAVEN and 63 days for patients receiving control therapy. Table 2 reports the most common adverse reactions occurring in at least 10% of patients in either group.
Table 2: Adverse Reactionsa with a Per-Patient Incidence of at Least 10% in Study 1
Adverse Reactions HALAVEN
n=503 Control Group
n=247
All Grades ≥ Grade 3 All Grades ≥ Grade 3
Blood and lymphatic system disordersb
Neutropenia 82% 57% 53% 23%
Anemia 58% 2% 55% 4%
Nervous system disorders
Peripheral neuropathyc 35% 8% 16% 2%
Headache 19% <1% 12% <1%
General disorders
Asthenia/Fatigue 54% 10% 40% 11%
Pyrexia 21% <1% 13% <1%
Mucosal inflammation 9% 1% 10% 2%
Gastrointestinal disorders
Nausea 35% 1% 28% 3%
Constipation 25% 1% 21% 1%
Vomiting 18% 1% 18% 1%
Diarrhea 18% 0 18% 0
Musculoskeletal and connective tissue disorders
Arthralgia/Myalgia 22% <1% 12% 1%
Back pain 16% 1% 7% 2%
Bone pain 12% 2% 9% 2%
Pain in extremity 11% 1% 10% 1%
Metabolism and nutrition disorders
Decreased weight 21% 1% 14% <1%
Anorexia 20% 1% 13% 1%
Respiratory, thoracic, and mediastinal disorders
Dyspnea 16% 4% 13% 4%
Cough 14% 0 9% 0
Skin and subcutaneous tissue disorders
Alopecia 45% NAd 10% NAd
Infections
Urinary Tract Infection 10% 1% 5% 0
a. adverse reactions were graded per National Cancer Institute Criteria for Adverse Events version 4.0.
b based upon laboratory data
c includes peripheral neuropathy, peripheral sensorimotor neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia.
d not applicable; (grading system does not specify > Grade 2 for alopecia).
Cytopenias: Grade 3 neutropenia occurred in 28% (143/503) of patients who received HALAVEN in Study 1, and 29% (144/503) of patients experienced Grade 4 neutropenia. Febrile neutropenia occurred in 5% (23/503) of patients; two patients (0.4%) di |
