Table 3.

Overall summary of adverse events (ITT population)

CategoryPatients (N = 25), n (%)
Adverse events25 (100)
 Any AE related* to study intervention24 (96)
 Any AE ≥ grade 324 (96)
 AE grade 3 hematologic21 (84)
 AE grade 3 nonhematologic23 (92)
 AE grade 4 hematologic23 (92)
 AE grade 4 nonhematologic7 (28)
 Any AE related* to study intervention and ≥grade 321 (84)
Serious adverse events13 (52)
 Any SAE related* to study intervention7 (28)
 Any SAE ≥ grade 312 (48)
 Any SAE related* to study intervention and ≥grade 37 (28)
 Any SAEs with fatal outcome0
  • 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.