Safety and Tolerability
Adverse reactions occurring in ≥10% (all grades) of patients in the LARTRUVO + doxorubicin arm and at a higher incidence than in the doxorubicin alone arm (between arm difference of ≥5% for all grades or ≥2% for Grades 3 and 4).
*Abdominal pain includes: abdominal pain, lower abdominal pain, and upper abdominal pain.
†Fatigue includes: asthenia and fatigue.
‡Musculoskeletal pain includes: arthralgia, back pain, bone pain, flank pain, groin pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, muscle spasms, neck pain, and pain in extremity.
The most common (≥20%) adverse reactions of LARTRUVO + doxorubicin were nausea, fatigue, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache.
- Adverse reactions resulting in permanent discontinuation of LARTRUVO occurred in 8% (5/64) of patients
- The most common adverse reaction leading to LARTRUVO discontinuation was infusion-related reaction (3%)
- Dose reductions of LARTRUVO for adverse reactions occurred in 25% (16/64) of patients; the most common adverse reaction leading to dose reduction was Grade 3 or 4 neutropenia (20%)
- Dose delays of LARTRUVO for adverse reactions occurred in 52% (33/64) of patients; the most common adverse reactions resulting in dose delays were neutropenia (33%), thrombocytopenia (8%), and anemia (5%)