Table 5.

Summary of Adverse Events in Patients Who Did and Those Who Did Not Receive Primary Prophylaxis with Granulocyte Colony-Stimulating Factor.

Events	A+AVD (N = 662)		ABVD (N = 659)
	No (N = 579)	Yes (N = 83)	No (N = 616)	Yes (N = 43)
		number (percent)
Febrile neutropenia during treatment	119 (21)	9 (11)	49 (8)	3 (7)
Any neutropenia*	425 (73)	29 (35)	352 (57)	9 (21)
Neutropenia grade ≥3*	406 (70)	24 (29)	309 (50)	8 (19)
Grade ≥3 adverse event	502 (87)	47 (57)	414 (67)	20 (47)
Infections and infestations (SOC)	322 (56)	39 (47)	312 (51)	19 (44)
Grade ≥3 infections and infestations (SOC)	107 (18)	9 (11)	63 (10)	3 (7)
Serious adverse event	257 (44)	27 (33)	171 (28)	7 (16)
Serious adverse events of febrile neutropenia, neutropenia, sepsis, neutropenic sepsis, pyrexia, or infections and infestations (SOC)	190 (33)	20 (24)	107 (17)	4 (9)
Deaths during treatment†	8 (1)	1 (1)‡	12 (2)	1 (2)

^*Neutropenia and neutropenia grade 3 or higher (neutrophil count <1000 per cubic millimeter) include the preferred terms of “neutropenia” and “neutrophil count decreased.” SOC denotes system organ class for the noted event.

^†Death during treatment is a death that occurred within 30 days after the last dose of frontline therapy.

^‡The patient in the A+AVD group who had G-CSF primary prophylaxis received G-CSF for treatment of neutropenia, which occurred before day 5.