Frequency of infusion-related reactions with CPX-351 treatment in an observational study in adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes (AML-MRC)

Figures & data

Table 1. Exposure to CPX-351.

n (%)	CPX-351 (N = 52)
Number of infusions
Patients received ≥1 infusion	52 (100)
Patients received 1 infusion	1 (2)
Patients received 2 infusions	2 (4)
Patients received 3 infusions	49 (94)
Number of infusions/patient
Mean (SD)	2.9 (0.3)
Median (range)	3.0 (1, 3)
Patients with dose interruptions during the treatment period	1 (2)
Patients with dose interruptions on Day 1 of infusion	1 (2)
Patients with dose interruptions on Day 3 of infusion	0
Patients with dose interruptions on Day 5 of infusion	0
Cumulative dose of daunorubicin, mg
Mean (SD)	238.2 (53.8)
Median (range)	247.5 (88, 339)
Cumulative dose of cytarabine, mg
Mean (SD)	542.4 (122.6)
Median (range)	562.5 (204, 774)

SD: standard deviation.

Table 2. Summary of TEAEs^a in all patients who received CPX-351.

n (%)	CPX-351 (N = 52)
Any TEAE^b	39 (75)
Constipation	9 (17)
Fatigue	7 (13)
Pneumonia	7 (13)
Peripheral edema	6 (12)
Headache	6 (12)
Any grade 3 or 4 TEAE^c	13 (25)
Anemia	3 (6)
Thrombocytopenia	2 (4)
White blood cell count decreased	2 (4)
Respiratory failure	2 (4)
Any serious TEAE	6 (12)
Respiratory failure	2 (4)
Pyrexia	1 (2)
Lung infection	1 (2)
Sepsis	1 (2)
Tumor lysis syndrome	1 (2)
Cerebrovascular accident	1 (2)
Thromboembolism	1 (2)
Dyspnea	1 (2)
Interruption due to TEAE	1 (2)
Discontinuation due to TEAE	0
Death due to TEAE	3 (6)

TEAE: treatment-emergent adverse event.

^aTEAEs reported during the 6-day study period from the start of the first CPX-351 infusion on Day 1 through 1 day after the last infusion (Day 6).

^bSubsequent list includes all individual TEAEs reported in >10% of patients.

^cSubsequent list includes all individual grade 3 or 4 TEAEs reported in >1 patient.

Data availability statement

All relevant data are provided within the manuscript and supporting files.