Table 4.
Main procedure-related adverse events by severity in all perfusions (n = 10), categorised as early phase (day 0–3) and late phase (day 4–6 weeks after perfusion)
| CTCAEa | All grades (n) | Grade 3 (n) | Grade 4 (n) |
|---|---|---|---|
| Haematological events | |||
| Anaemia | 9 | 1 | – |
| Early | 9 | 1 | – |
| Late | |||
| Thrombocytopenia | 9 | 1 | – |
| Early | 9 | – | 4 |
| Late | |||
| Leucopenia | 3 | – | – |
| Early | 8 | 1 | 7 |
| Late | |||
| Neutropenia | – | – | – |
| Early | 8 | – | 8 |
| Lateb | |||
| Lymphocytopenia | |||
| Early | 8 | 4 | 1 |
| Lateb | 9 | 6 | 1 |
| Hepatic events | |||
| Elevated AST level | 5 | – | – |
| Early | 3 | – | – |
| Lateb | |||
| Elevated ALT level | |||
| Early | 3 | – | – |
| Lateb | 2 | – | – |
| Elevated serum bilirubin level | |||
| Early | 1 | – | – |
| Lateb | 2 | – | – |
| Other | |||
| Fever | 2 | – | – |
| Thromboembolic eventc | 1 | 1 | – |
| Post-procedural haemorrhaged | 2 | – | – |
| Pharyngitise | 1 | 1 | – |
| Alopecia | 1 | – | – |
| Nausea | 2 | – | – |
| Oedema limbsf | 1 | – | – |
CTCAE common terminology criteria for adverse events, AST aspartate aminotransferase, ALT alanine aminotransferase
aGrades of adverse events were defined according to CTCAE (version 4.0)
bNot determined in 1 perfusion
cPulmonary emboli (PE) was diagnosed in one patient 17 days after PHP. Symptoms resolved in after treatment with low molecular weight heparin
dBleeding from puncture site groin, managed conservatively
eSepsis based on bacterial pharyngitis for which intravenous antibiotics and immunoglobulins were given, followed by aspiration of retropharyngeal abscess
fAs a result of administration of intravenous fluid during procedure