Table 3.
Overall summary of adverse events (ITT population)
| Category | Patients (N = 25), n (%) |
|---|---|
| Adverse events | 25 (100) |
| Any AE related* to study intervention | 24 (96) |
| Any AE ≥ grade 3 | 24 (96) |
| AE grade 3 hematologic† | 21 (84) |
| AE grade 3 nonhematologic† | 23 (92) |
| AE grade 4 hematologic† | 23 (92) |
| AE grade 4 nonhematologic† | 7 (28) |
| Any AE related* to study intervention and ≥grade 3 | 21 (84) |
| Serious adverse events | 13 (52) |
| Any SAE related* to study intervention | 7 (28) |
| Any SAE ≥ grade 3 | 12 (48) |
| Any SAE related* to study intervention and ≥grade 3 | 7 (28) |
| Any SAEs with fatal outcome | 0 |
Observation period: administration of high-dose melphalan (day –2) to end of intervention phase. AEs were coded using MedDRA Version 20.0.
SAE, serious AE.
*
Defined (by the investigator) as definitely related, probably related, possibly related, or unlikely related to T-cell infusion.
†
Hematologic AEs were defined as blood system disorders or investigations involving an increase/decrease in blood cells; nonhematologic AEs were defined as all other system/organ class terms.