Table 2.

Summary of treatment-emergent adverse events listed by system and class^*

	Grade 1–2	Grade 3	Grade 4
Blood and lymphatic system disorders	4 (8%)	13 (27%)	18 (37%)
Anaemia	5 (10%)	7 (14%)	0
Anaemia Heinz body	0	1 (2%)	0
Autoimmune haemolytic anaemia	0	1 (2%)	0
Febrile neutropenia	0	6 (12%)	0
Histiocytosis haemophagic†	0	0	1 (2%)
Immune thrombocytopenic purpura	1 (2%)	0	1 (2%)
Leucopenia	2 (4%)	5 (10%)	1 (2%)
Leukocytosis	0	0	1 (2%)
Lymphocytosis	0	1 (2%)	0
Lymphopenia	2 (4%)	3 (6%)	0
Neutropenia	1 (2%)	11 (22%)	15 (31%)
Thrombocytopenia	3 (6%)	3 (6%)	5 (10%)
Endocrine disorders	0	1 (2%)	0
Inappropriate antidiuretic hormone secretion	0	1 (2%)	0
Gastrointestinal disorders	42 (86%)	3 (6%)	0
Abdominal pain	5 (10%)	0	0
Constipation	8 (16%)	0	0
Diarrhoea	27 (55%)	1 (2%)	0
Dyspepsia	7 (14%)	0	0
Inguinal hernia	0	1 (2%)	0
Mouth ulceration	2 (4%)	1 (2%)	0
Nausea	25 (51%)	0	0
Vomiting	10 (20%)	0	0
General disorders and administrative site conditions	32 (65%)	3 (6%)	0
Chills	5 (10%)	0	0
Fatigue	18 (37%)	0	0
Oedema peripheral	8 (16%)	0	0
Pyrexia	16 (33%)‡	3 (6%)	0
Hepatobiliary disorders	1 (2%)	1 (2%)	0
Hyperbilirubinaemia	1 (2%)	1 (2%)	0
Infections and infestations	32 (65%)	8 (16%)	0
Bronchitis	5 (10%)	0	0
Clostridium difficile colitis	0	1 (2%)	0
Cystitis	0	1 (2%)	0
Haemophilus infection	1 (2%)	1 (2%)	0
Influenza	2 (4%)	1 (2%)	0
Lower respiratory tract infection	2 (4%)	3 (6%)	0
Parainfluenza virus infection	0	1 (2%)	0
Pneumonia	5 (10%)	3 (6%)	0
Rotavirus infection	1 (2%)	1 (2%)	0
Sinusitis	8 (16%)	0	0
Upper respiratory tract infection	28 (57%)	0	0
Urinary tract infection	10 (20%)	0	0
Injury and procedural complications	13 (27%)	3 (6%)	0
Contusion	6 (12%)	0	0
Infusion related reaction	5 (10%)	2 (4%)	0
Muscle injury	0	1 (2%)	0
Investigations	9 (18%)	7 (14%)	2 (4%)
Alanine aminotransferase increased	1 (2%)	1 (2%)	0
Aspartate aminotransferase increased	3 (6%)	2 (4%)	0
Gamma-glutamyl transferase increased	0	1 (2%)	0
Neutrophil count decreased	1 (2%)	1 (2%)	2 (4%)
Weight increased	1 (2%)	1 (2%)	0
White blood cell count decreased 1	(2%)	1 (2%)	0
Metabolism and nutrition disorders	24 (49%)	9 (18%)	1 (2%)
Decreased appetite	8 (16%)	0	0
Dehydration	2 (4%)	1 (2%)	0
Fluid overload	7 (14%)	0	0
Hyperglycaemia	2 (4%)	2 (4%)	0
Hyperkalaemia	5 (10%)	1 (2%)	0
Hyperuricaemia	2 (4%)	0	1 (2%)
Hypokalaemia	5 (10%)	1 (2%)	0
Hypomagnesaemia	8 (16%)	0	0
Hyponatraemia	0	1 (2%)	0
Hypophosphataemia	5 (10%)	2 (4%)	0
Tumour lysis syndrome	0	2 (4%)	0
Musculoskeletal and connective tissue disorders	27 (55%)	2 (4%)	0
Arthralgia	7 (14%)	0	0
Osteoarthritis	1 (2%)	1 (2%)	0
Rheumatoid arthritis	0	1 (2%)	0
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	6 (12%)	6 (12%)	0
Basal cell carcinoma	2 (4%)	1 (2%)	0
Fibrous histiocytoma	0	1 (2%)	0
Lung adenocarcinoma	0	1 (2%)	0
Malignant neoplasm progression	1 (2%)	2 (4%)	0
Squamous cell carcinoma of skin	2 (4%)	2 (4%)	0
Nervous system disorders	26 (53%)	0	0
Dizziness	7 (14%)	0	0
Headache	16 (33%)	0	0
Respiratory, thoracic, and mediastinal disorders	32 (65%)	2 (4%)	0
Atelectasis	0	1 (2%)	0
Cough	20 (41%)	0	0
Nasal congestion	9 (18%)	0	0
Oropharyngeal pain	6 (12%)	1 (2%)	0
Skin and subcutaneous tissue disorders	29 (59%)	0	0
Pruritus	9 (18%)	0	0
Rash	6 (12%)	0	0
Vascular disorders	8 (16%)	2 (4%)	0
Hypertension	2 (4%)	2 (4%)	0

Data are the total number of events; rows are listed by specific causes. Three treatment-emergent deaths were noted: one due to metabolism and nutrition disorders (reported as hyperkalaemia and tumour lysis syndrome), and two due to neoplasms (one reported as Richter’s syndrome, the other reported as malignant neoplasm progression).

^*Treatment-emergent adverse events in all 49 patients were reported for grade 1–2 occurring in 10% or more patients or more, and all grade 3–5 events.

^†Episode of fevers, rigors, and cytopenias triggered by rituximab infusion, with haemophagocytosis a prominent feature on bone marrow biopsy at the time.

^‡Pyrexia was a grade 1–2 serious adverse event in three patients.