Table 2. AEs Variable . Cohort 1 (2.0 ×... | American Society of Hematology

Table 2.

AEs

Variable	Cohort 1 (2.0 × 10¹¹ vg/kg)		Cohort 2 (1.0 × 10¹² vg/kg)				Cohort 3 (3.0 × 10¹² vg/kg)
Participant no.	1	2	3	4	5	8	6	7
AE possibly related to BAX 335, n	1	6	0	0	0	2	1	0
SAE unrelated* to BAX 335, n	1	NA	0	2	0	1	0	0
AEs possibly related to BAX 335, description (severity)	Tiredness (mild)	Feeling flushed (mild) Headache (mild) Influenza-like symptoms (mild) Ankle swelling (mild) Fatigue (moderate) Elevated liver enzyme levels (moderate)	NA	NA	NA	High blood pressure (mild) Left arm abscess (moderate)	Elevated liver enzyme levels (mild)	NA
SAEs unrelated* to BAX 335, description (severity)	Exercise-induced rhabdomyolysis (severe)	NA	NA	Bacterial infection of right tonsil (moderate)Tonsillar hemorrhage (moderate)	NA	Tonsillar carcinoma (severe)	NA	NA

Variable	Cohort 1 (2.0 × 10¹¹ vg/kg)		Cohort 2 (1.0 × 10¹² vg/kg)				Cohort 3 (3.0 × 10¹² vg/kg)
Participant no.	1	2	3	4	5	8	6	7
AE possibly related to BAX 335, n	1	6	0	0	0	2	1	0
SAE unrelated* to BAX 335, n	1	NA	0	2	0	1	0	0
AEs possibly related to BAX 335, description (severity)	Tiredness (mild)	Feeling flushed (mild) Headache (mild) Influenza-like symptoms (mild) Ankle swelling (mild) Fatigue (moderate) Elevated liver enzyme levels (moderate)	NA	NA	NA	High blood pressure (mild) Left arm abscess (moderate)	Elevated liver enzyme levels (mild)	NA
SAEs unrelated* to BAX 335, description (severity)	Exercise-induced rhabdomyolysis (severe)	NA	NA	Bacterial infection of right tonsil (moderate)Tonsillar hemorrhage (moderate)	NA	Tonsillar carcinoma (severe)	NA	NA

NA, not applicable.

No SAEs were considered related to BAX 335 treatment.