Clinical Safety and Immunogenicity of Tumor-Targeted, Plant-Made Id-KLH Conjugate Vaccines for Follicular Lymphoma

Table 3

Summary of adverse events reported during the vaccination phase of the study.

	Maximum CBER/NCI CTC grade by patient
	Total (related)	Grade 1	Grade 2	Grade 3	Grade 4
Local injection reactions	109 (96)	57	36	12	4
Systemic symptoms	140 (85)	61	71	8	0
Infections	11 (0)	2	9	0	0
Musculoskeletal	127 (81)	58	62	7	0
Gastrointestinal	42 (14)	30	11	1	0
Neurologic	7 ()	1	4	2	0
Other	7 (0)	2	5	0	0
Total	443 (278)	211	198	30 (20)	4 ( )

Total number of adverse events (AE) by category reported throughout the study regardless of attribution. Numbers in parenthesis indicate AE that were possibly, probably, or definitely related to vaccination. Study safety objectives are defined by the frequency of vaccination-related grade 3–5 AE. No grade 5 AE occurred.