Table 2.

Treatment-emergent AEs occurring in more than or equal to 15% of patients

N = 21
Any gradeGrade 1-2Grade 3-4Grade 5
Patients with an event, n (%)  21 (100) 4 (19.0) 13 (61.9) 4 (19.0) 
Diarrhea 15 (71.4) 14 (66.7) 1 (4.8) 
Headache 11 (52.4) 11 (52.4) 
Fatigue 10 (47.6) 10 (47.6) 
Neutropenia 8 (38.1) 1 (4.8) 7 (33.3) 
COVID-19 7 (33.3) 1 (4.8) 2 (9.5) 4 (19.0)  
Dizziness 7 (33.3) 7 (33.3) 
Cough 6 (28.6) 6 (28.6) 
Paresthesia 6 (28.6) 6 (28.6) 
Dyspnea 5 (23.8) 4 (19.0) 1 (4.8) 
Hypoesthesia 5 (23.8) 5 (23.8) 
Myalgia 5 (23.8) 5 (23.8) 
Memory impairment 4 (19.0) 4 (19.0) 
Peripheral edema 4 (19.0) 3 (14.3) 1 (4.8) 
Pruritus 4 (19.0) 4 (19.0) 
Upper respiratory tract infection 4 (19.0) 4 (19.0) 
Blurred vision 4 (19.0) 4 (19.0) 
N = 21
Any gradeGrade 1-2Grade 3-4Grade 5
Patients with an event, n (%)  21 (100) 4 (19.0) 13 (61.9) 4 (19.0) 
Diarrhea 15 (71.4) 14 (66.7) 1 (4.8) 
Headache 11 (52.4) 11 (52.4) 
Fatigue 10 (47.6) 10 (47.6) 
Neutropenia 8 (38.1) 1 (4.8) 7 (33.3) 
COVID-19 7 (33.3) 1 (4.8) 2 (9.5) 4 (19.0)  
Dizziness 7 (33.3) 7 (33.3) 
Cough 6 (28.6) 6 (28.6) 
Paresthesia 6 (28.6) 6 (28.6) 
Dyspnea 5 (23.8) 4 (19.0) 1 (4.8) 
Hypoesthesia 5 (23.8) 5 (23.8) 
Myalgia 5 (23.8) 5 (23.8) 
Memory impairment 4 (19.0) 4 (19.0) 
Peripheral edema 4 (19.0) 3 (14.3) 1 (4.8) 
Pruritus 4 (19.0) 4 (19.0) 
Upper respiratory tract infection 4 (19.0) 4 (19.0) 
Blurred vision 4 (19.0) 4 (19.0) 

Regardless of causality assessment.

A patient with multiple severity grades for a given AE is counted only once under the maximum severity.

A fifth patient died from COVID-19 infection outside the treatment-emergent period (30 days after discontinuation of all study drugs).

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