Table 6 Summary of unexpected adverse... | American Society of Hematology

Table 6

Summary of unexpected adverse events occurring within 30 days of T-cell infusion

Pt. no.	Infection cohort	Days since first infusion	Description of adverse event	Severity	Relationship to VST therapy	Center expected	Medical monitor- determined, unexpected grade 3-5 adverse events
16	EBV	40	TMA	3: Severe	3 - Possible	2 - No	Yes
24	EBV	19	Chronic cough	2: Moderate	3 - Possible	2 - No	No
24	EBV	28	TMA/hypoxia	4: Life threatening	3 - Possible	2 - No	Yes
47	EBV	1	Elevated lipase	3: Severe	3 - Possible	2 - No	Yes
47	EBV	1	Hemorrhage, gastrointestinal	3: Severe	3 - Possible	2 - No	Yes
61	CMV	28	Grade 4 neutropenia	3: Severe	1 - Unrelated	2 - No	Yes
76	AdV	6	Hemorrhagic cystitis	3: Severe	1 - Unrelated	2 - No	Yes
86	AdV	0	Anaphylaxis	4: Life threatening	2 - Unlikely	2 - No	Yes

Pt. no.	Infection cohort	Days since first infusion	Description of adverse event	Severity	Relationship to VST therapy	Center expected	Medical monitor- determined, unexpected grade 3-5 adverse events
16	EBV	40	TMA	3: Severe	3 - Possible	2 - No	Yes
24	EBV	19	Chronic cough	2: Moderate	3 - Possible	2 - No	No
24	EBV	28	TMA/hypoxia	4: Life threatening	3 - Possible	2 - No	Yes
47	EBV	1	Elevated lipase	3: Severe	3 - Possible	2 - No	Yes
47	EBV	1	Hemorrhage, gastrointestinal	3: Severe	3 - Possible	2 - No	Yes
61	CMV	28	Grade 4 neutropenia	3: Severe	1 - Unrelated	2 - No	Yes
76	AdV	6	Hemorrhagic cystitis	3: Severe	1 - Unrelated	2 - No	Yes
86	AdV	0	Anaphylaxis	4: Life threatening	2 - Unlikely	2 - No	Yes

TMA, thrombotic microangiopathy.