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Table 2 Treatment-related adverse events for all cohorts

From: Phase I study evaluating the Fc-optimized FLT3 antibody FLYSYN in AML patients with measurable residual disease

SOC

CTCAE term

All subjects (n = 31)

Grade 1

Grade 2

Grade 3

Any grade

Patients with events

All terms

8 (25.8)

4 (12.9)

3 (9.7)

15 (48.4)

Blood and lymphatic system disorders

Anemia, n (%)

5 (16.1)

1 (3.2)

0

6 (19.4)

Gastrointestinal disorders

Nausea, n (%)

1 (3.2)

0

0

1 (3.2)

General disorders and administration site conditions

Chills, n (%)

2 (6.5)

0

0

2 (6.5)

 

Edema limbs, n (%)

1 (3.2)

0

0

1 (3.2)

 

Fatigue, n (%)

3 (9.7)

0

0

3 (9.7)

 

Fever, n (%)

3 (9.7)

0

0

3 (9.7)

 

Flu like symptoms, n (%)

2 (6.5)

0

0

2 (6.5)

 

Non-cardiac chest pain, n (%)

1 (3.2)

0

0

1 (3.2)

Investigations

Blood bilirubin increased, n (%)

2 (6.5)

0

0

2 (6.5)

 

Investigations—Other, interleukin 2 receptor increased, n (%)

1 (3.2)

0

0

1 (3.2)

 

Lymphocyte count decreased, n (%)

3 (9.7)

1 (3.2)

0

4 (12.9)

 

Neutrophil count decreased, n (%)

2 (6.5)

3 (9.7)

2 (6.5)

7 (22.6)

 

Platelet count decreased, n (%)

2 (6.5)

0

0

2 (6.5)

 

WBC decreased, n (%)

3 (9.7)

3 (9.7)

0

6 (19.4)

Musculoskeletal and connective tissue disorders

Back pain, n (%)

0

0

1 (3.2)

1 (3.2)

 

Pain in extremity, n (%)

1 (3.2)

1 (3.2)

0

2 (6.5)

Nervous system disorders

Dizziness, n (%)

1 (3.2)

1 (3.2)

0

2 (6.5)

 

Dysesthesia, n (%)

1 (3.2)

0

0

1 (3.2)

 

Headache, n (%)

1 (3.2)

0

0

1 (3.2)

 

Paresthesia, n (%)

2 (6.5)

0

0

2 (6.5)

Vascular disorders

Hypertension, n (%)

0

1 (3.2)

0

1 (3.2)

 

Hypotension, n (%)

2 (6.5)

0

0

2 (6.5)

  1. Adverse events (AEs) and serious AEs are classified according to CTCAE V4.03. Severity and relationship were judged by the investigator. AEs are reported until the primary safety endpoint, i.e., until Visit 7 or Visit 9a for cohorts 1–5 or cohort 6, respectively. For each patient, AEs occurring at least once were counted with the highest CTCAE grading
  2. CTCAE common terminology criteria for adverse events, n number, SOC system organ class, WBC white blood cell