ointestinal disorders
Abdominal tenderness 26 (11.8) 1 (1.1)
Constipation 74 (33.6) 6 (6.5)
Diarrhea 80 (36.4) 13 (14.1)
Gingival bleeding 21 (9.5) 4 (4.3)
Loose stools 12 (5.5) 0
Mouth hemorrhage 11 (5.0) 1 (1.1)
Nausea 155 (70.5) 16 (17.4)
Stomatitis 17 (7.7) 0
Vomiting 119 (54.1) 5 (5.4)
General disorders and administration site conditions
Chest pain 36 (16.4) 5 (5.4)
Injection site bruising 31 (14.1) 0
Injection site erythema 77 (35.0) 0
Injection site granuloma 11 (5.0) 0
Injection site pain 50 (22.7) 0
Injection site pigmentation changes 11 (5.0) 0
Injection site pruritus 15 (6.8) 0
Injection site reaction 30 (13.6) 0
Injection site swelling 11 (5.0) 0
Lethargy 17 (7.7) 2 (2.2)
Malaise 24 (10.9) 1 (1.1)
Pyrexia 114 (51.8) 28 (30.4)
Infections and infestations
Nasopharyngitis 32 (14.5) 3 (3.3)
Pneumonia 24 (10.9) 5 (5.4)
Upper respiratory tract infection 28 (12.7) 4 (4.3)
Injury, poisoning, and procedural complications
Post procedural hemorrhage 13 (5.9) 1 (1.1)
Metabolism and nutrition disorders
Anorexia 45 (20.5) 6 (6.5)
Musculoskeletal and connective tissue disorders
Arthralgia 49 (22.3) 3 (3.3)
Chest wall pain 11 (5.0) 0
Myalgia 35 (15.9) 2 (2.2)
Nervous system disorders
Dizziness 41 (18.6) 5 (5.4)
Headache 48 (21.8) 10 (10.9)
Psychiatric disorders
Anxiety 29 (13.2) 3 (3.3)
Insomnia 24 (10.9) 4 (4.3)
Respiratory, thoracic and mediastinal disorders
Dyspnea 64 (29.1) 11 (12.0)
Skin and subcutaneous tissue disorders
Dry skin 11 (5.0) 1 (1.1)
Ecchymosis 67 (30.5) 14 (15.2)
Erythema 37 (16.8) 4 (4.3)
Rash 31 (14.1) 9 (9.8)
Skin nodule 11 (5.0) 1 (1.1)
Urticaria 13 (5.9) 1 (1.1)
Vascular disorders
Hematoma 19 (8.6) 0
Hypotension 15 (6.8) 2 (2.2)
Petechiae 52 (23.6) 8 (8.7)
Table 2 presents adverse reactions occurring in at least 5% of patients treated with VIDAZA in Study 4. Similar to Studies 1 and 2 described above, duration of exposure to treatment with VIDAZA was longer (mean 12.2 months) compared with best supportive care (mean 7.5months).
Table2: Most Frequently Observed Adverse Reactions (≥ 5.0% in the VIDAZA Treated Patients and the Percentage with NCI CTC Grade 3/4 Reactions; Study4) Number (%) of Patients
Any Grade Grade 3/4
System Organ Class
Preferred Terma VIDAZA
(N=175) Best Supportive Care Only
(N=102) VIDAZA
(N=175) Best Supportive Care Only
(N=102)
a Multiple reports of the same preferred term from a patient were only counted once within each treatment.
Blood and lymphatic system disorders
Anemia 90 (51.4) 45 (44.1) 24 (13.7) 9 (8.8)
Febrile neutropenia 24 (13.7) 10 (9.8) 22 (12.6) 7 (6.9)
Leukopenia 32 (18.3) 2 (2.0) 26 (14.9) 1 (1.0)
Neutropenia 115 (65.7) 29 (28.4) 107 (61.1) 22 (21.6)
Thrombocytopenia 122 (69.7) 35 (34.3) 102 (58.3) 29 (28.4)
Gastrointestinal disorders
Abdominal pain 22 (12.6) 7 (6.9) 7 (4.0) 0
Constipation 88 (50.3) 8 (7.8) 2 (1.1) 0
Dyspepsia 10 (5.7) 2 (2.0) 0 0
Nausea 84 (48.0) 12 (11.8) 3 (1.7) 0
Vomiting 47 (26.9) 7 (6.9) 0 0
General disorders and administration site conditions
Fatigue 42 (24.0) 12 (11.8) 6 (3.4) 2 (2.0)
Injection site bruisin
