Table 2.

Treatment-emergent AEs occurring in ≥ 5 patients (15%), regardless of attribution

AEsAll patients (N = 27)
All gradesGrade ≥ 3*
Any AE 27 (100) 10 (37) 
Nausea 25 (93) 3 (11) 
Diarrhea 21 (78) 
Vomiting 11 (41) 1 (4) 
Fatigue 10 (37) 2 (7) 
Constipation 9 (33) 
Headache 8 (30) 
Dizziness 7 (26) 
Abdominal pain 6 (22) 
Taste disorder 6 (22) 
Decreased appetite 6 (22) 
Insomnia 6 (22) 1 (4) 
Anemia 5 (19) 
Thrombocytopenia 5 (19) 
AEsAll patients (N = 27)
All gradesGrade ≥ 3*
Any AE 27 (100) 10 (37) 
Nausea 25 (93) 3 (11) 
Diarrhea 21 (78) 
Vomiting 11 (41) 1 (4) 
Fatigue 10 (37) 2 (7) 
Constipation 9 (33) 
Headache 8 (30) 
Dizziness 7 (26) 
Abdominal pain 6 (22) 
Taste disorder 6 (22) 
Decreased appetite 6 (22) 
Insomnia 6 (22) 1 (4) 
Anemia 5 (19) 
Thrombocytopenia 5 (19) 

All data are n (%).

*

One grade 4 event (atrial fibrillation; n = 1), but no grade 5 events, occurred during the study.

Includes the terms “thrombocytopenia” and “platelet count decreased,” as defined by the Medical Dictionary for Regulatory Activities.

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