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Table 5 Adverse events of grade ≥3 with an incidence of ≥3% and serious adverse events in >1 patient, safety population

From: Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results

Adverse event Cohort 1: pertuzumab, trastuzumab, and vinorelbine N = 106
Any grade ≥3 adverse event 64 (60.4%)
 Neutropenia 33 (31.1%)
 Leukopenia 14 (13 · 2%)
 Diarrhea 7 (6.6%)
 Anemia 6 (5.7%)
 Febrile neutropenia 6 (5.7%)
 Asthenia 5 (4.7%)
 Constipation 4 (3.8%)
 Fatigue 4 (3.8%)
Total number of serious adverse events 44
Number of patients with ≥1 serious adverse event 32 (30.2%)
 Febrile neutropenia 6 (5.7%)
 Hypersensitivity 5 (4.7%)
 Abdominal pain 2 (1.9%)
 Drug hypersensitivity 2 (1.9%)
 Pneumonia 2 (1.9%)
 Pyrexia 2 (1.9%)
 Septic shock 2 (1.9%)a
Adverse events leading to death (grade 5) 2 (1.9%)a–c
  1. Data reported are n (%)
  2. aOne patient died from septic shock while on treatment
  3. bOne patient died of a myocardial infarction while on treatment
  4. cA further 21 deaths were recorded at the end of the study but they did not occur while patients were on study treatment; one death due to pneumonia, two deaths due to unknown causes, and 18 deaths due to disease progression