Table 2.
Total number of adverse events of any grade occurring in the safety analysis population
| n (%) | Total (n = 4) |
|---|---|
| Any adverse eventa | 4 (100) |
| Gastrointestinal disorders | 4 (100) |
| Diarrhoea | 4 (100) |
| Nausea | 2 (50.0) |
| Stomatitis | 2 (50.0) |
| Abdominal pain | 1 (25.0) |
| Periodontal disease | 1 (25.0) |
| Vomiting | 1 (25.0) |
| Anal inflammation | 1 (25.0) |
| Metabolism and nutrition disorders | 4 (100) |
| Decreased appetite | 4 (100) |
| Investigations | 3 (75.0) |
| Neutrophil count decreased | 3 (75.0) |
| Blood bilirubin increased | 1 (25.0) |
| Platelet count decreased | 1 (25.0) |
| General disorders and administration site conditions | 2 (50.0) |
| Malaise | 2 (50.0) |
| Peripheral oedema | 1 (25.0) |
| Infections and infestations | 1 (25.0) |
| Nasopharyngitis | 1 (25.0) |
| Musculoskeletal and connective tissue disorders | 1 (25.0) |
| Muscle spasms | 1 (25.0) |
| Nervous system disorders | 1 (25.0) |
| Cholinergic syndrome | 1 (25.0) |
| Psychiatric disorders | 1 (25.0) |
| Insomnia | 1 (25.0) |
| Renal and urinary disorders | 1 (25.0) |
| Chromaturia | 1 (25.0) |
| Proteinuria | 1 (25.0) |
| Respiratory, thoracic, and mediastinal disorders | 1 (25.0) |
| Epistaxis | 1 (25.0) |
| Hiccups | 1 (25.0) |
| Skin and subcutaneous tissue disorders | 1 (25.0) |
| Dry skin | 1 (25.0) |
| Skin hyperpigmentation | 1 (25.0) |
| Vascular disorders | 1 (25.0) |
| Hypertension | 1 (25.0) |
aAdverse events were coded using the medical dictionary for regulatory activities version 18.0