Adverse events ≥grade 3 and their relation to treatment for individual patients
| Patient | Related to | ||||
| ID | (S)AE term | Grade | Chemo | TIL | IFNa |
| Cohort 1 without IFNa | |||||
| P1* | Neutrophil count decreased | 3 | YES | y/n | – |
| Platelet count decreased | 3 | YES | NO | – | |
| White cell count decreased (pan cytopenia) | 3 | YES | NO | – | |
| Lymphocyte count decreased | 3 | YES | y/n | – | |
| Anemia | 3 | y/n | y/n | – | |
| Nausea | 3 | y/n | NO | – | |
| P2 | Neutrophil count decreased | 3 | YES | NO | – |
| P3 | Neutrophil count decreased | 4 | YES | NO | – |
| White cell count decreased | 3 | YES | NO | – | |
| P4 | Neutrophil count decreased | 3 | YES | NO | – |
| P5 | Neutrophil count decreased | 3 | YES | NO | – |
| Upper respiratory infection | 3 | NO | NO | . | |
| P6 | Vomiting | 3 | y/n | NO | – |
| Diarrhea | 3 | YES | NO | – | |
| P7 | None | – | – | – | – |
| P11 | None | – | – | – | – |
| P12 | Neutrophil count decreased | 4 | YES | NO | – |
| P13 | Neutrophil count decreased | 3 | YES | NO | – |
| P14 | Neutrophil count decreased | 3 | YES | NO | – |
| P15 | Neutrophil count decreased | 3 | YES | NO | – |
| P16 | Neutrophil count decreased | 4 | YES | NO | – |
| Cohort two with IFNa | |||||
| P8* | None | – | – | – | – |
| P9 | Platelet count decreased | 3 | YES | y/n | y/n |
| White cell count decreased (pancytopenia) | 3 | YES | y/n | NO | |
| Neutrophil count decreased | 4 | YES | y/n | y/n | |
| P10 | Neutrophil count decreased | 4 | YES | y/n | y/n |
| White cell count decreased | 3 | YES | NO | y/n | |
| Platelet count decreased | 3 | y/n | NO | y/n | |
| Other general; malaise with PD | 3 | NO | NO | NO | |
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.