Table 3

Most common (≥3% of patients overall) drug-related grade ≥3 AEs, overall and within the dose-escalation and expansion cohorts

AE (MedDRA preferred term), n (%)Dose-escalation cohorts (n = 26)Expansion cohorts (n = 40)*Total (n = 60)
Thrombocytopenia 7 (27) 18 (45) 22 (37) 
Neutropenia 4 (15) 7 (18) 10 (17) 
Skin and SC tissue disorders 1 (4) 4 (10) 5 (8) 
Fatigue 4 (10) 4 (7) 
Lymphopenia 3 (8) 3 (5) 
Abdominal pain 1 (4) 1 (3) 2 (3) 
Hypophosphatemia 2 (8) 2 (3) 
Leukopenia 2 (5) 2 (3) 
Orthostatic hypotension 1 (4) 1 (3) 2 (3) 
WBC count decreased 1 (4) 1 (3) 2 (3) 
AE (MedDRA preferred term), n (%)Dose-escalation cohorts (n = 26)Expansion cohorts (n = 40)*Total (n = 60)
Thrombocytopenia 7 (27) 18 (45) 22 (37) 
Neutropenia 4 (15) 7 (18) 10 (17) 
Skin and SC tissue disorders 1 (4) 4 (10) 5 (8) 
Fatigue 4 (10) 4 (7) 
Lymphopenia 3 (8) 3 (5) 
Abdominal pain 1 (4) 1 (3) 2 (3) 
Hypophosphatemia 2 (8) 2 (3) 
Leukopenia 2 (5) 2 (3) 
Orthostatic hypotension 1 (4) 1 (3) 2 (3) 
WBC count decreased 1 (4) 1 (3) 2 (3) 

WBC, white blood cell.

*

Includes 6 patients treated at 2.0 mg/m2 in the dose-escalation cohorts.

MedDRA System Organ Class includes rash macular (n = 3, 5%), rash, and rash papular (each n = 1, 2%).

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