Table 4.

Summary of AEs of special interest (safety analysis set)

AE of special interestMAGNOLIA study (N = 68)
Any Grade AEGrade ≥3 AE
Any AE of special interest 54 (79.4) 23 (33.8) 
Infections 38 (55.9) 15 (22.1) 
Opportunistic infections 3 (4.4) 2 (2.9) 
Bleeding 28 (41.2) 1 (1.5) 
Major hemorrhage  1 (1.5) 1 (1.5) 
Second primary malignancies 5 (7.4) 3 (4.4) 
Skin cancers 2 (2.9) 
Neutropenia  11 (16.2) 8 (11.8) 
Thrombocytopenia  11 (16.2) 3 (4.4) 
Anemia 4 (5.9) 2 (2.9) 
Hypertension 3 (4.4) 2 (2.9) 
Atrial fibrillation/flutter 2 (2.9) 1 (1.5) 
Ventricular arrhythmia 1 (1.5) 
AE of special interestMAGNOLIA study (N = 68)
Any Grade AEGrade ≥3 AE
Any AE of special interest 54 (79.4) 23 (33.8) 
Infections 38 (55.9) 15 (22.1) 
Opportunistic infections 3 (4.4) 2 (2.9) 
Bleeding 28 (41.2) 1 (1.5) 
Major hemorrhage  1 (1.5) 1 (1.5) 
Second primary malignancies 5 (7.4) 3 (4.4) 
Skin cancers 2 (2.9) 
Neutropenia  11 (16.2) 8 (11.8) 
Thrombocytopenia  11 (16.2) 3 (4.4) 
Anemia 4 (5.9) 2 (2.9) 
Hypertension 3 (4.4) 2 (2.9) 
Atrial fibrillation/flutter 2 (2.9) 1 (1.5) 
Ventricular arrhythmia 1 (1.5) 

Data are number (%).

Defined as any serious or grade ≥3 bleed at any site, or central nervous system bleed of any grade.

“Neutropenia” included the terms “neutropenia” and “neutrophil count decreased.”

“Thrombocytopenia” included the terms “thrombocytopenia” and “platelet count decreased.”

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