Safety
pneumonitis, Pyrexia, dyspnea, pyrexia, dry cough
PNEUMONITIS, ADVERSE EVENTS, ADVERSE EVENT, MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS NEC, ADVERSE EVENT, LUNG DISORDER, INTERSTITIAL LUNG DISEASE
The summary of AEs is shown in Table Summary of adverse events across all cycles (safety analysis set).Abbreviations: AE, adverse event.Adverse events, occurring in more than 50% of patients, were common side effects of TC chemotherapy, and therefore the relationships with the study drug were mostly ruled out (Table The incidence of AEs in cycles 1–4 was 100.0% (101/101), 92.9% (92/99), 87.8% (86/98), and 86.0% (80/93), respectively. The incidence of study drug‐related AEs in cycles 1–4 was 45.5% (46/101), 27.3% (27/99), 22.4% (22/98), and 16.1% (15/93), respectively. Pyrexia, a study drug‐related AE, gradually increased in frequency during the course of chemotherapy. The incidence of pyrexia in cycles 1–4 was 3.0% (3/101), 6.1% (6/99), 6.1% (6/98), and 6.5% (6/93), respectively. All cases were nonserious, grade 1 or grade 2 in severity, did not lead to study withdrawal, and recovered. Pyrexia did not tend to worsen in severity over chemotherapy cycles.We calculated the incidence of adverse events of special interest (AESIs) based on the risk management plan of the originator (Table Adverse events of special interest across all cycles (safety analysis set).Abbreviations: AESIs, adverse events of special interest; CTCAE, common terminology criteria for adverse events.AESIs classified as “Musculoskeletal and connective tissue disorders” by MedDRA System Organ Class.AESIs classified as “interstitial lung disease”, “dyspnea”, “dyspnea exertional”, “lung disorder”, and “pneumonitis” by MedDRA Preferred Term and “dry cough” by MedDRA Lowest Level Term;CTCAE grade 3 is defined as platelet count of <50000/mmRegarding immunogenicity assessment, ADAs were negative in all patients.