Adverse events of interest
| Event | Number of patients |
|---|---|
| Pneumococcal meningitis (SAE) | 1 |
| Breast cancer* (SAE) | 1 |
| Headache† | 9 |
| Neutropenia‡ | 5 |
| Pneumonia | 1 |
| Sinusitis | 1 |
| Rhinitis/pharyngitis | 7 |
| Bronchitis | 1 |
| Herpes labialis | 1 |
| Oral aphtosis | 1 |
| Urinary tract infection | 2 |
| Gastroenteritis/diarrhoea | 2 |
| Scleroderma | 1 |
*Outside the study period: 15 months after enrolment in the trial (3 months after the last infusion).
†Headache at the end of the infusion.
‡Mild, transient, no infections between 1000 and 1500.
SAE, serious adverse event.