Table 2

Proportion of patients with AE grade 3 and 4 during cycles 1 to 12 and GVHD and secondary malignancies during follow-up

Grade 3Grade 4
Any grade 3/4 AE, % 53 23 
    Blood/bone marrow, % 27 17 
    Metabolic/laboratory, % 23 
    Infection, % 17 — 
GVHD, patients (%) 16 (53) — 
    Acute GVHD ≥ grade 2, patients (%) 11 (37) — 
        Skin/skin + liver/liver/gut, patients 5/3/2/1 — 
        Grade 2/3/4, patients 5/6/0 — 
        Classic/late onset, patients 4/7 — 
    Chronic extensive GVHD, patients (%) 5 (17) — 
Secondary malignancy, patients (%) — 2 (6.7)* 
Grade 3Grade 4
Any grade 3/4 AE, % 53 23 
    Blood/bone marrow, % 27 17 
    Metabolic/laboratory, % 23 
    Infection, % 17 — 
GVHD, patients (%) 16 (53) — 
    Acute GVHD ≥ grade 2, patients (%) 11 (37) — 
        Skin/skin + liver/liver/gut, patients 5/3/2/1 — 
        Grade 2/3/4, patients 5/6/0 — 
        Classic/late onset, patients 4/7 — 
    Chronic extensive GVHD, patients (%) 5 (17) — 
Secondary malignancy, patients (%) — 2 (6.7)* 

— indicates none (ie, no patients).

*

Two solid tumors were reported during follow-up: one ovarian tumor and one breast carcinoma.

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