Treatment of Alzheimer's Disease subjects with expanded non-genetically modified autologous natural killer cells (SNK01): a phase I study

Table 2 Summary of treatment-emergent adverse events by Severity and by Treatment Cohort – Safety Population

System Organ Class (SOC) Preferred Term (PT)	Cohort 1 N = 4		Cohort 2 N = 4		Cohort 3 N = 3		All subjects N = 11
System Organ Class (SOC) Preferred Term (PT)	Gr ≤ 2 n (%)	Gr ≥ 3 n (%)	Gr ≤ 2 n (%)	Gr ≥ 3 n (%)	Gr ≤ 2 n (%)	Gr ≥ 3 n (%)	Gr ≤ 2 n (%)	Gr ≥ 3 n (%)
Subjects with at least one TEAE	3 (75.0)	0	4 (100)	1 (25.0)	2 (66.7)	0	9 (81.8)	1 (9.1)
General disorders and administration site conditions	3 (75.0)	0	4 (100)	1 (25.0)	2 (66.7)	0	9 (81.8)	1 (9.1)
Puncture site pain	2 (50.0)	0	3 (75.0)	0	2 (66.7)	0	7 (63.6)	0
Vessel puncture site pain	0	0	3 (75.0)	0	1 (33.3)	0	4 (36.4)	0
Localised oedema	1 (25.0)	0	0	0	0	0	1 (9.1)	0
Multiple organ dysfunction syndrome	0	0	0	1 (25.0)	0	0	0	1 (9.1)
Blood and lymphatic system disorders	0	0	2 (50.0)	0	2 (66.7)	0	4 (36.4)	0
Anaemia	0	0	2 (50.0)	0	2 (66.7)	0	4 (36.4)	0
Vascular disorders	0	0	2 (50.0)	0	0	0	2 (18.2)	0
Hypertension	0	0	2 (50.0)	0	0	0	2 (18.2)	0
Nervous system disorders	0	0	1 (25.0)	0	1 (33.3)	0	2 (18.2)	0
Lethargy	0	0	1 (25.0)	0	0	0	1 (9.1)	0
Somnolence	0	0	1 (25.0)	0	0	0	1 (9.1)	0
Headache	0	0	0	0	1 (33.3)	0	1 (9.1)
Infections and infestations	1 (25.0)	0	0	1 (25.0)	0	0	1 (9.1)	1 (9.1)
Urinary tract infection	1 (25.0)	0	0	0	0	0	1 (9.1)	0
Sepsis	0	0	0	1 (25.0)	0	0	0	1 (9.1)
Skin and subcutaneous tissue disorders	0	0	0	1 (25.0)	0	0	0	1 (9.1)
Decubitus ulcer	0	0	0	1 (25.0)	0	0	0	1 (9.1)
Skin ulcer	0	0	0	1 (25.0)	0	0	0	1 (9.1)

N Number of subjects in the analysis population
Percentages are based on N. TEAEs are defined as AEs not present before the start of SNK01-related procedures, or AEs present before and worsened after the first session of SNK01 treatment. If a partially missing date or time of onset allows the possibility that an AE may be a TEAE it will be assumed that it is a TEAE. SOCs and Preferred Terms (PTs) are sorted in descending order for All Subjects, Cohort 1, Cohort 2, and Cohort 3 respectively. Subjects are counted once within each level of summarization (System Organ Class and Preferred Term)

ISSN: 1758-9193