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Table 3 Hematologic and Non-Hematologic Adverse Events Related to Ezatiostat in ≥ 5% of Patients

From: Phase 1-2a multicenter dose-escalation study of ezatiostat hydrochloride liposomes for injection (Telintra®, TLK199), a novel glutathione analog prodrug in patients with myelodysplastic syndrome

For All Dose Groups Combined Maximum Toxicity Grade (N = 54)

Adverse Event

(Preferred Term)

Grade 1

n (%)

Grade 2

n (%)

Grade 3

n (%)

Grade 4

n (%)

All Grades

n (%)

Hematologic

     

   Anemia

0 (0)

0 (0)

1 (2)

1 (2)

2 (4)

   Leukocytosis

0 (0)

1 (2)

0 (0)

0 (0)

1 (2)

   Leukopenia

0 (0)

0 (0)

1 (2)

0 (0)

1 (2)

   Thrombocytopenia

0 (0)

1 (2)

0 (0)

0 (0)

1 (2)

Non-hematologic

     

   Chills

6 (11)

5 (9)

0 (0)

0 (0)

11 (20)

   Back Pain

8 (15)

1 (2)

0 (0)

1 (2)

10 (19)

   Drug Hypersensitivity

4 (7)

1 (2)

3 (6)

2 (4)

10 (19)

   Flushing

10 (19)

0 (0)

0 (0)

0 (0)

10 (19)

   Nausea

8 (15)

0 (0)

1 (2)

0 (0)

9 (17)

   Bone Pain

3 (6)

3 (6)

2 (4)

0 (0)

8 (15)

   Dyspnea

5 (9)

2 (4)

0 (0)

0 (0)

7 (13)

   Fatigue

0 (0)

7 (13)

0 (0)

0 (0)

7 (13)

   Pain in Extremity

4 (7)

2 (4)

1 (2)

0 (0)

7 (13)

   Diarrhea

4 (7)

2 (4)

0 (0)

0 (0)

6 (11)

   Chest Pain

2 (4)

1 (2)

2 (4)

0 (0)

5 (9)

   Dizziness

4 (7)

0 (0)

1 (2)

0 (0)

5 (9)

   Chest Discomfort

3 (6)

1 (2)

0 (0)

0 (0)

4 (7)

   Headache

3 (6)

1 (2)

0 (0)

0 (0)

4 (7)

   Vomiting

4 (7)

0 (0)

0 (0)

0 (0)

4 (7)

   Abdominal Pain Upper

2 (4)

1 (2)

0 (0)

0 (0)

3 (6)

   Arthralgia

2 (4)

1 (2)

0 (0)

0 (0)

3 (6)

   Musculoskeletal Discomfort

3 (6)

0 (0)

0 (0)

0 (0)

3 (6)

   Insomnia

2 (4)

1 (2)

0 (0)

0 (0)

3 (6)