Table 2.
Adverse events (AE) related to the combination of chemotherapy plus tocilizumab.
| Number of patients with AE median AE/patients | Grade 1 |
Grade 2 |
Grade 3 |
Grade 4 |
Grade 5 |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| 8 |
12 |
10 |
6 |
2 |
||||||
| 2 |
6 |
3 |
1 |
1 |
||||||
| Before injection (D1–D7) | From Tocilizumab injection (from D8) | Before injection (D1–D7) | From Tocilizumab injection (from D8) | Before injection (D1–D7) | From Tocilizumab injection (from D8) | Before injection (D1–D7) | From Tocilizumab injection (from D8) | Before injection (D1–D7) | From Tocilizumab injection (from D8) | |
| Blood and lymphatic system disorders | 0 | 0 | 0 | 1 | 4 | 4 | 0 | 4 | 0 | 0 |
| Anaemia | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 |
| Febrile bone marrow aplasia | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Lymphadenopathy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 |
| Thrombocytopenia | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 0 |
| Ear and labyrinth disorders | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vertigo | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Eye disorders | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Lacrimation decreased | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Periorbital oedema | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Photophobia | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal disorders | 3 | 4 | 8 | 18 | 0 | 3 | 0 | 1 | 0 | 0 |
| Abdominal pain | 0 | 2 | 2 | 1 | 0 | 2 | 0 | 0 | 0 | 0 |
| Abdominal pain upper | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Colitis | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Constipation | 1 | 0 | 2 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Diarrhoea | 0 | 1 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Haemorrhoids | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Large intestine perforation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Lip dry | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea | 2 | 0 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vomiting | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| General disorders and administration site conditions | 0 | 1 | 0 | 3 | 1 | 2 | 0 | 1 | 0 | 0 |
| Mucosal inflammation | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 0 |
| Pain | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pyrexia | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Ulcer | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Infections and infestations | 0 | 0 | 0 | 2 | 5 | 15 | 0 | 1 | 0 | 1 |
| Appendicitis | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Bacillus infection | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Bacteraemia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Bacteroides bacteraemia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Escherichia bacteraemia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Escherichia urinary tract infection | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Fungal infection | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Klebsiella bacteraemia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Pneumonia | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
| Pseudomonal bacteraemia | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Sepsis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Septic shock | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Staphylococcal bacteraemia | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
| Staphylococcal infection | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Tooth infection | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Urinary tract infection enterococcal | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Urinary tract infection staphylococcal | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Injury, poisoning and procedural complications | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Eschar | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Transfusion-related immunomodulation reaction | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Metabolism and nutrition disorders | 3 | 5 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hyperkalaemia | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypokalaemia | 3 | 3 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Magnesium deficiency | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Malnutrition | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Starvation | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Renal cell carcinoma | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Nervous system disorders | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Haemorrhage intracranial | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Headache | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Parkinsonism | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Psychiatric disorders | 0 | 0 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Anxiety | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Insomnia | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Renal and urinary disorders | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Acute kidney injury | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Bladder dilatation | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Urinary retention | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Reproductive system and breast disorders | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Prostatic obstruction | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dyspnoea | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorders | 0 | 1 | 3 | 7 | 0 | 1 | 0 | 0 | 0 | 0 |
| Dry skin | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rash | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rash maculo-papular | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rash morbilliform | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Rash pruritic | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Skin mass | 0 | 0 | 1 | 4 | 0 | 1 | 0 | 0 | 0 | 0 |
| Vascular disorders | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 1 | 0 | 0 |
| Deep vein thrombosis | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypertension | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Shock haemorrhagic | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Thrombosis | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total | 6 | 12 | 23 | 50 | 10 | 28 | 0 | 8 | 0 | 2 |