Table 2.

Summary of TEAEs that occurred in ≥ 10% of patients.

Eribulin + pembrolizumab (N = 167)
Preferred term, n (%)Any gradeGrade 3 or 4
Fatigue110 (65.9)12 (7.2)
Nausea96 (57.5)4 (2.4)
Peripheral sensory neuropathy69 (41.3)12 (7.2)
Alopecia66 (39.5)0
Constipation61 (36.5)2 (1.2)
Neutropenia60 (35.9)44 (26.3)
Cough54 (32.3)0
Pyrexia53 (31.7)1 (0.6)
Decreased appetite52 (31.1)3 (1.8)
Diarrhea51 (30.5)6 (3.6)
Anemia47 (28.1)10 (6.0)
Arthralgia46 (27.5)2 (1.2)
Vomiting45 (26.9)3 (1.8)
Weight decreased41 (24.6)3 (1.8)
Headache41 (24.6)0
Dyspnea41 (24.6)5 (3.0)
Stomatitis32 (19.2)4 (2.4)
Rash31 (18.6)2 (1.2)
Hypothyroidism30 (18.0)0
Aspartate aminotransferase increased30 (18.0)6 (3.6)
Dehydration28 (16.8)2 (1.2)
Hypokalemia28 (16.8)9 (5.4)
Urinary tract infection27 (16.2)0
Dizziness27 (16.2)0
Dry mouth26 (15.6)0
Alanine aminotransferase increased26 (15.6)4 (2.4)
Pain in extremity25 (15.0)4 (2.4)
Abdominal pain24 (14.4)2 (1.2)
Back pain24 (14.4)4 (2.4)
Insomnia22 (13.2)0
Dyspepsia21 (12.6)0
Neutrophil count decreased21 (12.6)13 (7.8)
Pruritus21 (12.6)1 (0.6)
Hot flush21 (12.6)0
Musculoskeletal pain20 (12.0)1 (0.6)
Myalgia20 (12.0)2 (1.2)
White blood cell count decreased19 (11.4)9 (5.4)
Chills18 (10.8)0
Hyponatremia18 (10.8)9 (5.4)
Nasal congestion18 (10.8)0
Pneumonitis18 (10.8)4 (2.4)
Rash maculopapular18 (10.8)3 (1.8)
Hypomagnesemia17 (10.2)0
Upper respiratory tract infection16 (9.6)0
  • Abbreviation: TEAE, treatment-emergent adverse event.

  • Note: Adverse event terms were coded using Medical Dictionary for Drug Regulatory Affairs version 22.0 per protocol and were graded using Common Terminology Criteria for Adverse Events version 4.03. Patients who experienced different grades for a single preferred term were counted only once per preferred term using the highest severity grade.