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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)