Table 4.
TEAEs leading to study discontinuation
| Treatment group | Dose type | Preferred term | Intensity | Outcome | Causality | SAE? |
|---|---|---|---|---|---|---|
| 0.5 g/kg | Induction | Autoimmune hepatitis | Moderate | Not resolved | Not related | No |
| 2.0 g/kg | Induction | Fibrin D dimer increased | Mild | Unknown | Unlikely | No |
| 0.5 g/kg | Maintenance | Osteonecrosis | Moderate | Not resolved | Unlikely | Yes |
| 2.0 g/kg | Maintenance | Encephalitis | Severe | Fatal | Not related | Yes |
| 1.0 g/kg |
Maintenance Maintenance |
Dermatitis allergic Urinary tract infection |
Moderate Moderate |
Resolved Resolved |
Probable Not related |
No No |
SAE serious adverse event, TEAE treatment-emergent adverse event