Varicella zoster immune globulin (human) (VARIZIG) in immunocompromised patients: a subgroup analysis for safety and outcomes from a large, expanded-access program

Gans, Hayley; Chemaly, Roy F.

doi:10.1186/s12879-020-05656-6

Table 4 Safety in immunocompromised children

From: Varicella zoster immune globulin (human) (VARIZIG) in immunocompromised patients: a subgroup analysis for safety and outcomes from a large, expanded-access program

Preferred term	Type of immune-compromising condition, n (%)
Preferred term	All (n = 263)	Primary immunodeficiency^a (n = 13)	Oncologic immunodeficiency^b (n = 152)	Solid organ transplant^c (n = 36)	Hematopoietic cell transplant^d (n = 17)	Other^e (n = 45)
AEs
Participants, n (%)	90 (34)	5 (38)	62 (41)	9 (25)	4 (24)	10 (22)
Total AEs, n	402	15	318	22	30	17
Total related AEs, n	53	7	32^f	6	4	4
Related AEs occurring in > 1 participant^g, n (%)
Injection site pain	5 (2)	2 (15)	2 (1)	1 (6)	0	0
Headache	2 (0.8)	1 (8)	0	0	1 (6)	0
Diarrhea	2 (0.8)	0	0	1 (6)	1 (6)	0
Serious AEs
Participants, n (%)	42 (16)	3 (23)	28 (18)	5 (14)	2 (12)	4 (9)
Total serious AEs, n	93	6	68	5	7	7
Total related serious AEs, n	1	0	1	0	0	0
All related serious AEs, n (%)
Serum sickness	1 (0.4)	0	1 (0.6)	0	0	0
Deaths, n (%)^h	5 (2)	0	3 (2)	0	1 (6)	1 (3)

^aIncludes participants with primary immunodeficiencies (e.g. cell-mediated immune deficiency, combined immunodeficiency, DiGeorge syndrome, histiocytosis, HIV infection/AIDS, immunodeficiency common variable, lymphoproliferative disorder, myelodysplastic syndrome, ulcerative colitis, Wiskott-Aldrich syndrome)
^bIncludes participants with oncologic immunodeficiencies
^cIncludes participants who have undergone SOT and are taking anti-rejection medication
^dIncludes participants who have undergone HCT
^eIncludes participants with other immunocompromising conditions (e.g. adrenoleukodystrophy, anemia, aplasia pure red cell, asthma, chronic granulomatous disease, Evan’s syndrome, focal segmental glomerulosclerosis, Goodpasture’s syndrome, Henoch-Schönlein purpura nephritis, hypoplastic left heart syndrome, juvenile-onset arthritis, McKusick-Kaufman syndrome, lupus nephritis, nephrotic syndrome, ornithine transcarbamylase deficiency, polyarteritis nodosa, premature baby, thrombocytopenia, uveitis)
^fOne participant experienced 26 AEs, all of which were considered “conditionally” related to treatment, in that it is unclear how the participant’s underlying condition and treatment for that condition could have been involved in the causality of the reported AEs
^gRelated AEs occurring in one person each included: abdominal pain, arthritis reactive, aspartate aminotransferase, aspartate aminotransferase increased, blood lactate dehydrogenase, cough, fatigue, hemoglobin decreased, hyperglycemia, hypocalcemia, hypomagnesemia, hyponatremia, injection site hematoma, injection site swelling, insomnia, malaise, platelet count decreased, pyrexia, rash erythematous, serum sickness, urticaria, white blood cell count decreased
^hDeaths were due to acute myeloid leukemia, cardiac failure congestive, intracranial hemorrhage, neuroblastoma, and renal failure

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ISSN: 1471-2334

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