Table 2.
Incidence of adverse events (AEs)
| Patients with related adverse events grade <3 and ≥3 by dose level |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5 MIU (n = 3) |
5 MIU 20 mg/m2 doxo (n = 4) |
5 MIU 25 mg/m2 doxo (n = 3) |
10 MIU 25 mg/m2 doxo (n = 3) |
15 MIU 25 mg/m2 doxo (n = 3) |
25 MIU 25 mg/m2 doxo (n = 13) |
Any Dose (n = 29) |
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| Related AEs by system organ class | G<3 | G≥3 | G<3 | G≥3 | G<3 | G≥3 | G<3 | G≥3 | G<3 | G≥3 | G<3 | G≥3 | All Grade |
| Blood and lymphatic system disorders | 1 | 1 | 1 | 1 | 10 | 7 | 14 | ||||||
| Cardiac disorders | 1 | 1 | 2 | ||||||||||
| Eye disorders | 1 | 1 | |||||||||||
| Gastrointestinal disorders | 1 | 2 | 2 | 1 | 9 | 1 | 15 | ||||||
| General disorders and administration site conditions | 2 | 2 | 1 | 1 | 1 | 2 | 10 | 3 | 19 | ||||
| Investigations | 1 | 1 | 2 | ||||||||||
| Metabolism and nutrition disorders | 1 | 1 | 2 | 2 | 4 | ||||||||
| Muscoskeletal and connective tissue disorders | 1 | 1 | |||||||||||
| Nervous system disorders | 1 | 1 | |||||||||||
| Renal and urinary disorders | 1 | 1 | |||||||||||
| Reproductive system and breast disorders | 1 | 1 | |||||||||||
| Respiratory, thoracic and mediastinal disorders | 1 | 1 | 2 | ||||||||||
| Skin and subcutaneous tissue disorders | 2 | 3 | 5 | ||||||||||
| Vascular disorders | 1 | 1 | 2 | ||||||||||
The toxicities were graded according to Common Terminology Criteria for Adverse Events v 3.0. The System Organ Class was coded using the Medical Dictionary for Regulatory Activities. Blood and lymphatic system disorders include anaemia, neutropenia, and leucopenia; cardiac disorders include pericardial effusion and tachycardia; eye disorders include conjunctivitis; gastrointestinal disorders include constipation, vomiting, nausea, abdominal pain, stomatitis, gastritis, and oesophagitis; general disorders and administration site conditions include asthenia, pyrexia, fatigue, flu-like syndrome, and mucosal inflammation; investigations include weight decrease and increase of alanine aminotransferase, aspartate aminotransferase; metabolism and nutrition disorders include anorexia and hypokalaemia; muscoloskeletal and connective tissue disorders include arthralgia; nervous system disorders include headache; renal and urinary disorders include hyperazotemia; reproductive system and breast disorders include pelvic pain; respiratory, thoracic and mediastinal disorders include dyspnoea, sinusitis; skin and subcutaneous tissue disorders include alopecia, palmar-plantar erythrodysaestesia syndrome, and nail disorders; vascular disorders include hypertension and phlebitis.