Table 2.

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.