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 |
| 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.