Adverse events and outcomes
| MedDRA code | Patients | Severity (mild/moderate/severe/life-threatening) | Seriousness (nonserious/serious) | First 3 months after infusion | Outcome at 12 months | |
| Bronchitis | 10006451 | 8 (61.5) | 8/0/0/0 | 8/0 | 5 | Resolved |
| IPF clinical progression or worsening without hospitalisation | 10067761 | 5 (38.5) | 0/3/2/0 | 5/0 | 1 | 4 IPF progression 1 lung transplant |
| IPF worsening with hospitalisation (2 patients) | 10067761 10054112 | 3 (23.1)# | 0/2/1/0 | 0/3 | 1 | 1 death |
| Fever and/or dyspnoea after infusion | 10013968 10037660 | 3 (23.1) | 1/2/0/0 | 3/0 | 3 | Resolved |
| Upper respiratory tract infection/sinusitis | 10046309 | 2 (15.4) | 2/0/0/0 | 2/0 | 2 | Resolved |
| Flu-like syndrome | 10022004 | 2 (15.4) | 2/0/0/0 | 2/0 | 6 | Resolved |
| Acute gastroenteritis | 10066762 | 1 (7.7) | 1/0/0/0 | 1/0 | 1 | Resolved |
| Skin lesion | 10040882 | 1 (7.7) | 1/0/0/0 | 1/0 | 1 | Resolved |
| Legionella pneumonia with hospitalisation | 10035718 | 1 (7.7) | 0/0/0/1 | 0/1 | 0 | 1 death |
| Abdominal pain, weight decreased, and general deterioration | 10000081 10000159 10049438 | 1 (7.7) | 0/1/0/0 | 1/0 | 1 | 1 death |
| Prostate adenocarcinoma | 10060862 | 1 (7.7) | 0/1/0/0 | 0/1 | 0 | On treatment |
| Small cell lung cancer | 10041067 | 1 (7.7) | 1/0/0/0 | 0/1 | 0 | On treatment |
| Radiotherapy side-effects with hospitalisation (prostate cancer treatment) | 10037759 | 1 (7.7) | 0/1/0/0 | 1/0 | 0 | Resolved |
Data are presented as n (%) or n. MedDRA: Medical Dictionary for Regulatory Activities; IPF: idiopathic pulmonary fibrosis. #: one patient was hospitalised twice during a 2-month period.