Table 5.
Overview of TEAEs at 36 mo
| TEAEs | Treated patients (N = 80), n (%) | Number of events |
|---|---|---|
| Patients with TEAEs | ||
| Any | 80 (100.0) | 2446 |
| Drug relateda | 24 (30.0) | 83 |
| Not drug relateda | 56 (70.0) | 2363 |
| Mild | 1 (1.3) | 1441 |
| Moderate | 30 (37.5) | 847 |
| Severe | 49 (61.3) | 158 |
| Patients with SAEs (fatal and nonfatal) | ||
| Any | 70 (87.5) | 338 |
| Drug relateda | 5 (6.3) | 9 |
| Not drug relateda | 65 (81.3) | 329 |
| Patients with a confirmed clinically significant infectionb | 65 (81.3) | 354 |
| Deaths | 6 (7.5) | |
SAE, serious adverse event; TEAE, treatment‐emergent adverse event.
a
Drug‐related events are defined as those judged by the investigator to be possibly, probably, or definitely related to the study drug. Events that are judged by the investigator to be unlikely to be related or unrelated to study drug were defined as not drug‐related events.
b
Results include clinically significant for cytomegalovirus, BK virus, and encapsulated bacterial, fungal, and aspergillus infection confirmed by culture, biopsy, genomic, or serologic findings that required hospitalization or anti‐infective treatment, or otherwise deemed significant by the investigator.