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. Author manuscript; available in PMC: 2022 Apr 15.
Published in final edited form as: Lancet Haematol. 2019 May 3;6(6):e317–e327. doi: 10.1016/S2352-3026(19)30029-8

Table 4:

Adverse events

Guadecitabine 60 mg/m2 (n=53)
 Guadecitabine 90 mg/m2 (n=49)
Grade 1–2 Grade 3 Grade 4 Grade 1–2 Grade 3 Grade 4
Haematological events
Anaemia   4 (8%) 23 (43%)   2 (4%)   4 (8%) 19 (39%)   5 (10%)
Neutropaenia   4 (8%)   2 (4%) 19 (36%)   1 (2%)   4 (8%) 21 (43%)
Thrombocytopenia   1 (2%)   0 22 (41%)   0   5 (10%) 23 (47%)
Febrile neutropaenia   0 15 (28%)   2 (4%)   0 20 (41%)   1 (2%)
Leukopaenia   0   2 (4%)   5 (9%)   0   2 (4%)   6 (12%)
Non-haematological events
Injection site pain 19 (36%)   0   0 21 (43%)   0   0
Injection site haematoma   6 (11%)   0   0 11 (22%)   0   0
Injection site nodule   9 (17%)   0   0   8 (16%)   0   0
Fatigue 21 (40%)   4 (8%)   0 13 (27%)   6 (12%)   0
Diarrhoea 17 (32%)   0   0 21 (43%)   1 (2%)   0
Nausea 18 (34%)   0   0 19 (39%)   1 (2%)   0
Pneumonia   2 (4%) 13 (25%)   0   2 (4%) 14 (29%)   1 (2%)
Constipation 15 (28%)   0   0 18 (37%)   0   0
Cough 15 (28%)   0   0 15 (31%)   0   0
Confusion 16 (30%)   0   0 11 (22%)   1 (2%)   0
Decreased appetite 12 (23%)   0   0 15 (31%)   0   0
Insomnia 11 (21%)   0   0 14 (29%)   0   0
Dyspnoea 10 (19%)   1 (2%)   0 12 (24%)   1 (2%)   0
Stomatitis   3 (6%)   2 (4%)   0 15 (31%)   3 (6%)   0
Hypokalaemia   7 (13%)   1 (2%)   0 11 (22%)   3 (6%)   0
Vomiting 10 (19%)   0   0 11 (22%)   1 (2%)   0
Dizziness 12 (23%)   0   0   9 (18%)   0   0
Hypomagnesaemia 13 (25%)   0   0   7 (14%)   1 (2%)   0
Peripheral oedema 12 (23%)   0   0   9 (18%)   0   0
Epistaxis 10 (19%)   1 (2%)   0   8 (16%)   1 (2%)   0
Headache   6 (11%)   1 (2%)   0 13 (27%)   0   0
Rash 11 (21%)   0   0   9 (18%)   0   0
Asthaenia   9 (17%)   1 (2%)   0   9 (18%)   0   0
Pain in extremity   9 (17%)   1 (2%)   0   8 (16%)   0   0
Petechiae 11 (21%)   0   0   7 (14%)   0   0
Cellulitis   3 (6%)   3 (6%)   0   4 (8%)   7 (14%)   0
Pyrexia   3 (6%)   1 (2%)   0   8 (16%)   3 (6%)   0
Arthralgia   7 (13%)   2 (4%)   0   5 (10%)   0   0
Back pain   6 (11%)   2 (4%)   0   5 (10%)   1 (2%)   0
Dyspepsia   5 (9%)   0   0   9 (18%)   0   0
Myalgia 10 (19%)   0   0   4 (8%)   0   0
Upper respiratory tract infection   5 (9%)   0   0   8 (16%)   1 (2%)   0
Hyponatraemia   3 (6%)   4 (8%)   0   5 (10%)   1 (2%)   0
Nasal congestion   6 (11%)   0   0   7 (14%)   0   0
Oropharyngeal pain   6 (11%)   0   0   7 (14%)   0   0
Hypotension   4 (8%)   1 (2%)   0   6 (12%)   1 (2%)   0
Night sweats   4 (8%)   0   0   8 (16%)   0   0
Dehydration   3 (6%)   1 (2%)   0   6 (12%)   1 (2%)   0
Muscle spasms   8 (15%)   0   0   3 (6%)   0   0
Abdominal pain   7 (13%)   0   0   2 (4%)   1 (2%)   0
Rhinorrhea   6 (11%)   0   0   4 (8%)   0   0
Sepsis   0   2 (4%)   1 (2%)   0   1 (2%)   4 (8%)
Transfusion reaction   4 (8%)   1 (2%)   0   4 (8%)   1 (2%)   0
Weight decreased   6 (11%)   0   0   4 (8%)   0   0

Data are n (%). Two treatment-related deaths occurred (pneumonia with 90 mg/m2 and septic shock with 60 mg/m2) Events occurring in at least 10% of patients and all grade 3 or worse events are shown.