Table 3.
Incidence rates of adverse events of interest
| Patients with event | Incidence rate | ||
|---|---|---|---|
| n | % | Number of events per 100 patient-years | |
| Any AE | 116 | 95.9 | |
| Any IAR | 109 | 90.1 | |
| Any AE excluding IARs | 65 | 53.7 | 33.1 |
| Any AE leading to treatment discontinuation | 6a | 5.0 | |
| Any serious AE | 39 | 32.2 | |
| Any serious IAR | 15 | 12.4 | |
| Any SAE excluding IARs | 28 | 23.1 | 10.2 |
| Death | 2 | 1.7 | 0.6 |
| Any infection event | 30 | 24.8 | 11.8 |
| Serious infection event | 10 | 8.3 | 3.4 |
| Any autoimmune AE | 37 | 30.6 | 13.8 |
| Autoimmune thyroid event | 32 | 26.4 | 11.8 |
| Serious autoimmune thyroid event | 5 | 4.1 | 1.6 |
| ITP | 2 | 1.7 | 0.6 |
| Acute acalculous cholecystitis | 3 | 2.5 | 1.0 |
| Malignant disease | 4 | 3.3 | 1.3 |
AE adverse event, IAR infusion-associated reaction, SAE serious adverse event, ITP immune thrombocytopenic purpura
aIn addition, two patients (1.7%) discontinued due to lymphopenia, which we did not regard as an adverse event