Table II.
Adverse events possibly related to CTT administration by system organ class and preferred term
| FAS (N = 105) | ||
|---|---|---|
| n (%) | E | |
|
| ||
| Number of Related Adverse Events | 44 (41.9) | 87 |
| Blood and lymphatic system disorders | 21 (20.0) | 32 |
| Thrombocytopenia | 11 (10.5) | 13 |
| Neutropenia | 8 (7.6) | 8 |
| Coombs positive haemolytic anaemia | 3 (2.9) | 3 |
| Autoimmune haemolytic anaemia | 2 (1.9) | 3 |
| Haemolysis | 2 (1.9) | 2 |
| Haemolytic anaemia | 2 (1.9) | 2 |
| Immune thrombocytopenic purpura | 1 (1.0) | 1 |
| Skin and subcutaneous tissue disorders | 9 (8.6) | 10 |
| Alopecia | 4 (3.8) | 4 |
| Rash | 2 (1.9) | 2 |
| Granuloma skin | 1 (1.0) | 1 |
| Psoriasis | 1 (1.0) | 1 |
| Skin mass | 1 (1.0) | 1 |
| Stephens-Johnson syndrome | 1 (1.0) | 1 |
| General disorders and administration site conditions | 6 (5.7) | 6 |
| Pyrexia | 5 (4.8) | 5 |
| Oedema peripheral | 1 (1.0) | 1 |
| Renal and urinary disorders | 5 (4.8) | 6 |
| Proteinuria | 5 (4.8) | 5 |
| Glomerulonephritis minimal lesion | 1 (1.0) | 1 |
| Gastrointestinal disorders | 5 (4.8) | 5 |
| Diarrhoea | 3 (2.9) | 3 |
| Enteritis | 1 (1.0) | 1 |
| Ileus | 1 (1.0) | 1 |
| Injury, poisoning and procedural complications | 5 (4.8) | 5 |
| Wound dehiscence | 4 (3.8) | 4 |
| Graft haemorrhage | 1 (1.0) | 1 |
| Investigations | 4 (3.8) | 6 |
| Blood bicarbonate decreased | 2 (1.9) | 2 |
| Lymphocyte morphology abnormal | 1 (1.0) | 2 |
| Blood immunoglobulin E increased | 1 (1.0) | 1 |
| Lymphocyte count abnormal | 1 (1.0) | 1 |
| Infections and infestations | 4 (3.8) | 4 |
| Cytomegalovirus infection | 1 (1.0) | 1 |
| Staphylococcal skin infection | 1 (1.0) | 1 |
| Stitch abscess | 1 (1.0) | 1 |
| Wound infection staphylococcal | 1 (1.0) | 1 |
| Immune system disorders | 2 (1.9) | 3 |
| Graft versus Host Disease | 1 (1.0) | 1 |
| Graft versus Host Disease in gastrointestinal tract | 1 (1.0) | 1 |
| Graft versus Host Disease in skin | 1 (1.0) | 1 |
| Hepatobiliary disorders | 2 (1.9) | 2 |
| Autoimmune hepatitis | 2 (1.9) | 2 |
| Musculoskeletal and connective tissue disorders | 2 (1.9) | 2 |
| Juvenile idiopathic arthritis | 1 (1.0) | 1 |
| Psoriatic arthropathy | 1 (1.0) | 1 |
| Endocrine disorders | 1 (1.0) | 2 |
| Basedow's disease | 1 (1.0) | 1 |
| Hyperthyroidism | 1 (1.0) | 1 |
| Congenital, familial and genetic disorders | 1 (1.0) | 1 |
| Albinism | 1 (1.0) | 1 |
| Nervous system disorders | 1 (1.0) | 1 |
| Myelitis transverse | 1 (1.0) | 1 |
| Reproductive system and breast disorders | 1 (1.0) | 1 |
| Ovarian failure | 1 (1.0) | 1 |
| Vascular disorders | 1 (1.0) | 1 |
| Haematoma | 1 (1.0) | 1 |
Note: If a patient had multiple occurrences of an AE, the patient was included only once in the n for a given SOC and PT. Adverse events were coded using MedDRA version 19.1.
*
Related events were defined as events that were definitely, probably or possibly related to CTT or study procedures or with an unknown relationship based on investigator review.
AE, adverse event; E, number of events; FAS, full analysis set; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class