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Table 4 Overall Hematologic and Non-Hematologic Treatment-Emergent Adverse Events 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 (%)

Total

n (%)

Hematologic

     

   Anemia

0 (0)

3 (5.6)

11 (20.4)

4 (7.4)

18 (33.3)

   Thrombocytopenia

0 (0)

1 (1.9)

2 (3.7)

5 (9.3)

8 (14.8)

   Neutropenia

0 (0)

1 (1.9)

1 (1.9)

5 (9.3)

7 (13.0)

   Febrile Neutropenia

0 (0)

1 (1.9)

4 (7.4)

0 (0)

5 (9.3)

   Leukopenia

0 (0)

0 (0)

2 (3.7)

1 (1.9)

3 (5.6)

Non-Hematologic

     

   Diarrhea

13 (24.1)

6 (11.1)

3 (5.6)

0 (0)

22 (40.7)

   Nausea

15 (27.8)

3 (5.6)

1 (1.9)

0 (0)

19 (35.2)

   Fatigue

2 (3.7)

14 (25.9)

1 (1.9)

0 (0)

17 (31.5)

   Back Pain

11 (20.4)

3 (5.6)

0 (0)

1 (1.9)

15 (27.8)

   Bone Pain

6 (11.1)

5 (9.3)

3 (5.6)

0 (0)

14 (25.9)

   Headache

10 (18.5)

4 (7.4)

0 (0)

0 (0)

14 (25.9)

   Pain in Extremity

9 (16.7)

4 (7.4)

1 (1.9)

0 (0)

14 (25.9)

   Chills

7 (13.0)

6 (11.1)

0 (0)

0 (0)

13 (24.1)

   Vomiting

11 (20.4)

2 (3.7)

0 (0)

0 (0)

13 (24.1)

   Drug Hypersensitivity

5 (9.3)

1 (1.9)

4 (7.4)

2 (3.7)

12 (22.2)

   Pyrexia

11 (20.4)

0 (0)

0 (0)

0 (0)

11 (20.4)

   Flushing

10 (18.5)

0 (0)

0 (0)

0 (0)

10 (18.5)

   Insomnia

7 (13.0)

2 (3.7)

0 (0)

0 (0)

9 (16.7)

   Oedema Peripheral

7 (13.0)

2 (3.7)

0 (0)

0 (0)

9 (16.7)

   Constipation

3 (5.6)

5 (9.3)

0 (0)

0 (0)

8 (14.8)

   Chest Pain

3 (5.6)

2 (3.7)

2 (3.7)

1 (1.9)

8 (14.8)

   Cough

5 (9.3)

2 (3.7)

1 (1.9)

0 (0)

8 (14.8)

   Dizziness

7 (13.0)

0 (0)

1 (1.9)

0 (0)

8 (14.8)

   Dyspnoea

5 (9.3)

2 (3.7)

0 (0)

1 (1.9)

8 (14.8)

   Arthralgia

3 (5.6)

3 (5.6)

1 (1.9)

0 (0)

7 (13.0)

   Asthenia

4 (7.4)

3 (5.6)

0 (0)

0 (0)

7 (13.0)

   Contusion

7 (13.0)

0 (0)

0 (0)

0 (0)

7 (13.0)

   Decreased Appetite

4 (7.4)

2 (3.7)

1 (1.9)

0 (0)

7 (13.0)

   Dry Mouth

5 (9.3)

1 (1.9)

0 (0)

0 (0)

6 (11.1)

   Epistaxis

5 (9.3)

0 (0)

1 (1.9)

0 (0)

6 (11.1)

   Tachycardia

5 (9.3)

1 (1.9)

0 (0)

0 (0)

6 (11.1)

   Anorexia

3 (5.6)

1 (1.9)

1 (1.9)

0 (0)

5 (9.3)

   Chest Discomfort

4 (7.4)

1 (1.9)

0 (0)

0 (0)

5 (9.3)

   Dyspepsia

4 (7.4)

1 (1.9)

0 (0)

0 (0)

5 (9.3)

   Dyspnoea Exertional

1 (1.9)

4 (7.4)

0 (0)

0 (0)

5 (9.3)

   Ecchymosis

5 (9.3)

0 (0)

0 (0)

0 (0)

5 (9.3)

   Musculoskeletal Discomfort

5 (9.3)

0 (0)

0 (0)

0 (0)

5 (9.3)

   Somnolence

4 (7.4)

0 (0)

1 (1.9)

0 (0)

5 (9.3)

   Urinary Tract Infection

1 (1.9)

4 (7.4)

0 (0)

0 (0)

5 (9.3)

   Abdominal Pain Upper

2 (3.7)

2 (3.7)

0 (0)

0 (0)

4 (7.4)

   Depression

3 (5.6)

1 (1.9)

0 (0)

0 (0)

4 (7.4)

   Dry Skin

4 (7.4)

0 (0)

0 (0)

0 (0)

4 (7.4)

   Infusion Site Bruising

4 (7.4)

0 (0)

0 (0)

0 (0)

4 (7.4)

   Infusion Site Reaction

3 (5.6)

0 (0)

1 (1.9)

0 (0)

4 (7.4)

   Neck Pain

3 (5.6)

0 (0)

1 (1.9)

0 (0)

4 (7.4)

   Pneumonia

1 (1.9)

1 (1.9)

2 (3.7)

0 (0)

4 (7.4)

   Pruritus

4 (7.4)

0 (0)

0 (0)

0 (0)

4 (7.4)

   Rash

4 (7.4)

0 (0)

0 (0)

0 (0)

4 (7.4)

   Anxiety

2 (3.7)

1 (1.9)

0 (0)

0 (0)

3 (5.6)

   Conjunctival Hemorrhage

3 (5.6)

0 (0)

0 (0)

0 (0)

3 (5.6)

   Dehydration

1 (1.9)

0 (0)

1 (1.9)

1 (1.9)

3 (5.6)

   Dysgeusia

3 (5.6)

0 (0)

0 (0)

0 (0)

3 (5.6)

   Hematuria

2 (3.7)

0 (0)

1 (1.9)

0 (0)

3 (5.6)

   Hyperhidrosis

2 (3.7)

0 (0)

1 (1.9)

0 (0)

3 (5.6)

   Hypertension

1 (1.9)

2 (3.7)

0 (0)

0 (0)

3 (5.6)

   Hypokalemia

2 (3.7)

0 (0)

1 (1.9)

0 (0)

3 (5.6)

   Hypotension

1 (1.9)

1 (1.9)

1 (1.9)

0 (0)

3 (5.6)

   Infusion Site Erythema

2 (3.7)

1 (1.9)

0 (0)

0 (0)

3 (5.6)

   Infusion Site Pain

3 (5.6)

0 (0)

0 (0)

0 (0)

3 (5.6)

   Lung Infiltration

1 (1.9)

1 (1.9)

0 (0)

1 (1.9)

3 (5.6)

   Mouth Ulceration

3 (5.6)

0 (0)

0 (0)

0 (0)

3 (5.6)

   Musculoskeletal Stiffness

2 (3.7)

1 (1.9)

0 (0)

0 (0)

3 (5.6)

   Oedema

2 (3.7)

0 (0)

1 (1.9)

0 (0)

3 (5.6)

   Pharyngolaryngeal Pain

2 (3.7)

1 (1.9)

0 (0)

0 (0)

3 (5.6)

   Upper Respiratory Tract Infection

1 (1.9)

2 (3.7)

0 (0)

0 (0)

3 (5.6)

   Vision Blurred

2 (3.7)

1 (1.9)

0 (0)

0 (0)

3 (5.6)