Table 2

Adverse events ≥grade 3 and their relation to treatment for individual patients

PatientRelated to
ID(S)AE termGradeChemoTILIFNa
Cohort 1 without IFNa
P1*Neutrophil count decreased3YESy/n
Platelet count decreased3YESNO
White cell count decreased (pan cytopenia)3YESNO
Lymphocyte count decreased3YESy/n
P2Neutrophil count decreased3YESNO
P3Neutrophil count decreased4YESNO
White cell count decreased3YESNO
P4Neutrophil count decreased3YESNO
P5Neutrophil count decreased3YESNO
Upper respiratory infection3NONO.
P12Neutrophil count decreased4YESNO
P13Neutrophil count decreased3YESNO
P14Neutrophil count decreased3YESNO
P15Neutrophil count decreased3YESNO
P16Neutrophil count decreased4YESNO
Cohort two with IFNa
P9Platelet count decreased3YESy/ny/n
White cell count decreased (pancytopenia)3YESy/nNO
Neutrophil count decreased4YESy/ny/n
P10Neutrophil count decreased4YESy/ny/n
White cell count decreased3YESNOy/n
Platelet count decreased3y/nNOy/n
Other general; malaise with PD3NONONO
  • All grade 3 or more (S)AEs and their relation to therapy according to CTCAE V.4.03 are given. (S)AEs grade 4 are in bold. Relatedness to therapy: YES; definitely related, NO; definitely not related and y/n; possibly related. ‘–‘=not applicable.

  • *P1 and P8 grossly deviated from treatment schedule and were only evaluated for safety/feasibility.

  • CTCAE, Common Terminology Criteria for Adverse Events; PD, progressive disease; (S)AE, (serious) adverse events.