Table 4.
Grade 3 or 4 adverse events in the modified intention-to-treat population
|
Grade 3 |
Grade 4 |
||||||
|---|---|---|---|---|---|---|---|
| Imatinib group (n=197) | Placebo group (n=188) | Total (n=385) | Imatinib group (n=197) | Placebo group (n=188) | Total (n=385) | ||
| Any adverse event | 156 (79%) | 218 (116%) | 374 (97%) | 32 (16%) | 42 (22%) | 74 (19%) | |
| Anaemia | 3 (2%) | 7 (4%) | 10 (3%) | 0 | 0 | 0 | |
| Cardiac disorders | |||||||
| Atrioventricular block complete | 0 | 1 (1%) | 1 (<1%) | 0 | 0 | 0 | |
| Myocardial infarction | 0 | 1 (1%) | 1 (<1%) | 0 | 0 | 0 | |
| Rhythm disorder (atrial fibrillation or flutter) | 4 (2%) | 4 (2%) | 8 (2%) | 0 | 2 (1%) | 2 (1%) | |
| Sinus bradycardia | 0 | 1 (1%) | 1 (<1%) | 0 | 1 (1%) | 1 (<1%) | |
| Myringitis with bloody otorrhoea | 0 | 1 (1%) | 1 (<1%) | 0 | 0 | 0 | |
| Adrenal insufficiency | 0 | 2 (1%) | 2 (1%) | 0 | 0 | 0 | |
| Eye disorders | |||||||
| Conjunctivitis | 0 | 1 (1%) | 1 (<1%) | 0 | 0 | 0 | |
| Other | 0 | 0 | 0 | 1 (1%)* | 0 | 1 (<1%) | |
| Gastrointestinal disorders | |||||||
| Diarrhoea | 1 (1%) | 0 | 1 (<1%) | 0 | 0 | 0 | |
| Ileus | 0 | 1 (1%) | 1 (<1%) | 0 | 0 | 0 | |
| Rectal haemorrhage | 0 | 1 (1%) | 1 (<1%) | 0 | 1 (1%) | 1 (<1%) | |
| Vomiting | 0 | 1 (1%) | 1 (<1%) | 0 | 0 | 0 | |
| Gastric ulcer | 0 | 0 | 0 | 1 (1%) | 0 | 1 (<1%) | |
| General disorders and administration site conditions | |||||||
| Fever | 1 (1%) | 3 (2%) | 4 (1%) | ||||
| Multiorgan failure | 0 | 0 | 0 | 0 | 1 (1%) | 1 (<1%) | |
| Infections and infestations | |||||||
| Lip infection | 0 | 2 (1%) | 2 (1%) | 0 | 0 | 0 | |
| Lung infection (other than COVID-19) | 7 (4%) | 10 (5%) | 17 (4%) | 0 | 0 | 0 | |
| Other† | 5 (3%) | 4 (2%) | 9 (2%) | 0 | 0 | 0 | |
| Sepsis | 1 (1%) | 2 (1%) | 3 (1%) | 0 | 0 | 0 | |
| Investigations | |||||||
| Increased blood ALT or AST | 6 (3%) | 5 (3%) | 11 (3%) | 0 | 0 | 0 | |
| Increased blood bilirubin | 1 (1%) | 2 (1%) | 3 (1%) | 0 | 0 | 0 | |
| Increased blood creatinine | 2 (1%) | 1 (1%) | 3 (1%) | 0 | 0 | 0 | |
| Increased blood γ-glutamyl transferase | 0 | 3 (2%) | 3 (1%) | 0 | 0 | 0 | |
| Prolonged QT corrected interval | 8 (4%) | 14 (7%) | 22 (6%) | 0 | 0 | 0 | |
| Decreased lymphocyte count | 20 (10%) | 15 (8%) | 35 (9%) | 0 | 0 | 0 | |
| Decreased white blood cell count | 0 (0) | 1 (1) | 1 (<1%) | 0 | 0 | 0 | |
| Increased creatinine | 0 | 0 | 0 | 0 | 1 (1%) | 1 (<1%) | |
| Decreased platelet count | 0 | 0 | 0 | 1 (1%) | 1 (1%) | 2 (1%) | |
| Metabolism and nutrition disorders | |||||||
| Acidosis | 10 (5%) | 8 (4%) | 18 (5%) | 1 (1%) | 5 (3%) | 6 (2%) | |
| Alkalosis | 21 (11%) | 20 (11%) | 41 (11%) | 0 | 0 | 0 | |
| Anorexia | 1 (1%) | 0 | 1 (<1%) | 0 | 0 | 0 | |
| Hyperglycaemia | 22 (11%) | 37 (20%) | 59 (15%) | 0 | 0 | 0 | |
| Hyperkalaemia | 1 (1%) | 6 (3%) | 7 (2%) | 0 | 0 | 0 | |
| Hypernatremia | 1 (1%) | 4 (2%) | 5 (1%) | 0 | 1 (1%) | 1 (<1%) | |
| Hypoalbuminemia | 2 (1%) | 5 (3%) | 7 (2%) | 0 | 0 | 0 | |
| Hypokalaemia | 2 (1%) | 3 (2%) | 5 (1%) | 1 (1%) | 0 | 1 (<1%) | |
| Hyponatremia | 1 (1%) | 3 (2%) | 4 (1%) | 0 | 0 | 0 | |
| Benign, malignant, or unspecified neoplasm | 0 | 0 | 0 | 0 | 1 (1%)‡ | 1 (<1%) | |
| Nervous system disorders | |||||||
| Peripheral motor neuropathy | 0 | 2 (1%) | 2 (1%) | 0 | 0 | 0 | |
| Ischaemic stroke | 0 | 2 (1%) | 2 (1%) | 0 | 0 | 0 | |
| Delirium | 2 (1%) | 12 (6%) | 14 (4%) | 0 | 1 (1%) | 1 (<1%) | |
| Renal and urinary disorders | |||||||
| Haematuria | 1 (1%) | 2 (1%) | 3 (1%) | 0 | 0 | 0 | |
| Acute kidney injury | 0 | 0 | 0 | 0 | 2 (1%) | 2 (1%) | |
| Respiratory, thoracic, and mediastinal disorders | |||||||
| Acute respiratory distress syndrome | 9 (5%) | 6 (3%) | 15 (4%) | 26 (13%) | 20 (11%) | 46 (12%) | |
| Pneumothorax | 1 (1%) | 0 | 1 (<1%) | 1 (1%) | 0 | 1 (<1%) | |
| Pulmonary fibrosis | 1 (1%) | 0 | 1 (<1%) | 0 | 0 | 0 | |
| Other§ | 4 (2%) | 2 (1%) | 6 (2%) | 1 (1%) | 0 | 1 (<1%) | |
| Aspiration | 0 | 0 | 0 | 0 | 1 (1%) | 1 (<1%) | |
| Skin and subcutaneous tissue disorders | |||||||
| Maculopapular rash | 1 (1%) | 0 | 1 (<1%) | 0 | 0 | 0 | |
| Other | 1 (1%)¶ | 0 | 1 (<1%) | 0 | 0 | 0 | |
| Vascular disorders | |||||||
| Hypotension | 1 (1%) | 7 (4%) | 8 (2%) | 0 | 1 (1%) | 1 (<1%) | |
| Thromboembolic event | 18 (9%) | 14 (7%) | 32 (8%) | 1 (1%) | 0 | 1 (<1%) | |
The severity of adverse events was graded according to the Common Terminology Criteria for Adverse Events, version 5.0. All patients who received at least one dose of study medication were included in the safety population. ALT=alanine aminotransferase. AST=aspartate aminotransferase.
Patient developed a conjunctivitis with a haematoma in both eyes. The patient was unmasked and treatment was discontinued; symptoms resolved shortly thereafter.
Defined as a positive throat swab culture that resulted in starting intravenous antibiotic, antifungal, or antiviral treatment.
Patient was diagnosed with a malignancy.
Six patients were readmitted to the hospital ward: four due to complaints of dyspnoea, one due to pneumonia unrelated to COVID-19, and one due to exacerbation of chronic obstructive pulmonary disease.
Patient was diagnosed with a leukocytoclastic vasculitis, confirmed by skin biopsy.