Table 3. Severe AEs reported Patient .... | American Society of Hematology

Table 3.

Severe AEs reported

Patient	Days after first VST infusion	Grade	Caused by infusion	Event
1	54	4	Unlikely	Mycobacterium tuberculosis (pulmonary, blood) with sclerosing peritonitis*
6	12	3	Unlikely	Enterococcus faecalis bacteremia (blood/Hickman catheter)
	31	3	Unlikely	Escherichia coli UTI, Rhinovirus RTI
	50	3	Unlikely	Bacillus spp bacteremia
	89	4	Unlikely	aGVHD skin, liver, gut (overall grade IV)*
8	15	3	Unlikely	Aspergillus spp (pulmonary)
9	31, 40, 165	3	Unlikely	Febrile, no organism identified
10	0	3	Unlikely	Febrile, S epidermidis sepsis
11	60	3	Unlikely	Bloody diarrhea, cultures PCR negative
	85	3	Unlikely	Suspected infected central venous catheter; no organism isolated
13	39	4	Unlikely	Progressive pulmonary infiltrate and fibrosis†
	76	3	Unlikely	BK virus hemorrhagic cystitis
	105	5	Unlikely	Pulmonary veno-occlusive disease, severe pulmonary hypertension*
	131	3	Unlikely	Bilateral lower limb DVTs
16	131	3	Unlikely	Chronic gastritis, CMV negative
17	157	3	Unlikely	Pseudomonas aeruginosa vulval lesions
20	189	3	Unlikely	Fracture neck of femur
21	1	3	Unlikely	S epidermidis bacteremia (blood, Hickman catheter)
22	25	3	Unlikely	Acute renal failure, hypercalcemia
	71	5	Unlikely	Pseudomonas aeruginosa pneumonia (BAL, sputum)*
23	94	3	Unlikely	Clostridium difficile colitis
26	4	3	Unlikely	BK virus hemorrhagic cystitis
	27	3	Unlikely	Cryptogenic organizing pneumonia
	57	4	Possible	LFT derangement in context of weaning from immunosuppression, suspected acute liver GVHD (stage 4)*
	75	3	Unlikely	Escherichia coli and carbapenem-resistant Enterobacteriaceae sepsis
	78	5	Possible	Biopsy-proven acute gut GVHD (stage 4, overall grade 4 with liver)*
30	8	3	Unlikely	Infective exacerbation of COPD, cultures negative

Patient	Days after first VST infusion	Grade	Caused by infusion	Event
1	54	4	Unlikely	Mycobacterium tuberculosis (pulmonary, blood) with sclerosing peritonitis*
6	12	3	Unlikely	Enterococcus faecalis bacteremia (blood/Hickman catheter)
	31	3	Unlikely	Escherichia coli UTI, Rhinovirus RTI
	50	3	Unlikely	Bacillus spp bacteremia
	89	4	Unlikely	aGVHD skin, liver, gut (overall grade IV)*
8	15	3	Unlikely	Aspergillus spp (pulmonary)
9	31, 40, 165	3	Unlikely	Febrile, no organism identified
10	0	3	Unlikely	Febrile, S epidermidis sepsis
11	60	3	Unlikely	Bloody diarrhea, cultures PCR negative
	85	3	Unlikely	Suspected infected central venous catheter; no organism isolated
13	39	4	Unlikely	Progressive pulmonary infiltrate and fibrosis†
	76	3	Unlikely	BK virus hemorrhagic cystitis
	105	5	Unlikely	Pulmonary veno-occlusive disease, severe pulmonary hypertension*
	131	3	Unlikely	Bilateral lower limb DVTs
16	131	3	Unlikely	Chronic gastritis, CMV negative
17	157	3	Unlikely	Pseudomonas aeruginosa vulval lesions
20	189	3	Unlikely	Fracture neck of femur
21	1	3	Unlikely	S epidermidis bacteremia (blood, Hickman catheter)
22	25	3	Unlikely	Acute renal failure, hypercalcemia
	71	5	Unlikely	Pseudomonas aeruginosa pneumonia (BAL, sputum)*
23	94	3	Unlikely	Clostridium difficile colitis
26	4	3	Unlikely	BK virus hemorrhagic cystitis
	27	3	Unlikely	Cryptogenic organizing pneumonia
	57	4	Possible	LFT derangement in context of weaning from immunosuppression, suspected acute liver GVHD (stage 4)*
	75	3	Unlikely	Escherichia coli and carbapenem-resistant Enterobacteriaceae sepsis
	78	5	Possible	Biopsy-proven acute gut GVHD (stage 4, overall grade 4 with liver)*
30	8	3	Unlikely	Infective exacerbation of COPD, cultures negative

BAL, bronchoalveolar lavage; COPD, chronic obstructive pulmonary disease; DVT, deep venous thrombosis; RTI, respiratory tract infection; UTI, urinary tract infection.

Contributed to death.

†

CMV detected but below level of quantification on broncho-alveolar lavage.

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