Extended Data Table 6 Adverse events of special interest

From: Trastuzumab deruxtecan in HER2-low metastatic breast cancer: long-term survival analysis of the randomized, phase 3 DESTINY-Breast04 trial

  1. ILD, interstitial lung disease; T-DXd, trastuzumab deruxtecan; TPC, treatment of physician’s choice of chemotherapy.
  2. aAt the primary analysis (data cutoff, 11 January 2022), grade 3 adjudicated drug-related ILD was reported in 5 patients (1.3%). At the current data cutoff, grade 3 adjudicated drug-related ILD was reported in 4 patients (1.1%) because 1 grade 3 ILD event worsened to grade 5 ILD. Consequently, there is an increase in the rate of grade 5 ILD (from 0.8% to 1.1%) without impacting the overall rate of adjudicated drug-related ILD. No ILD cases were pending adjudication at the updated data cutoff.
  3. bLeft ventricular dysfunction includes acute left ventricular failure, acute right ventricular failure, cardiac failure, acute cardiac failure, chronic cardiac failure, cardiac failure congestive, chronic left ventricular failure, chronic right ventricular failure, ejection fraction decreased, left ventricular failure, right ventricular failure, ventricular failure, and left ventricular dysfunction.
  4. cIf a patient had more than one event per category, the patient was counted once for each category; the patient who experienced a grade 3 cardiac failure also experienced grade 2 decreased ejection fraction.