Table 1. Case characteristics,... | American Society of Hematology

Table 1.

Case characteristics, definition, and related criteria for acute hemoglobinemia or hemoglobinuria

						Acute hemoglobinemia or hemoglobinuria case definition (and related) criteria
Case no.	Age, y	Sex	FDA received initial report	Indication for anti-D IGIV	Dose, μg/kg	Acute*	Hemoglobinemia†	Hemoglobinuria‡	MD assessment§
1	12	M	May 1999	ITP	50	—∥	—¶	Yes	Yes
2	85	M	Aug 1999	ITP	50	Yes	Yes	Yes	Yes
3	75	M	Aug 2002	ITP	48	Yes	—¶	Yes	Yes
4	25	F	Sep 2003	ITP	50	—∥	—¶	Yes	Yes
5	71	F	Sep 2004	ITP	75	Yes	—¶	Yes	Yes
6	67	M	Oct 2004	ITP	51	Yes	—¶	Yes	Yes

						Acute hemoglobinemia or hemoglobinuria case definition (and related) criteria
Case no.	Age, y	Sex	FDA received initial report	Indication for anti-D IGIV	Dose, μg/kg	Acute*	Hemoglobinemia†	Hemoglobinuria‡	MD assessment§
1	12	M	May 1999	ITP	50	—∥	—¶	Yes	Yes
2	85	M	Aug 1999	ITP	50	Yes	Yes	Yes	Yes
3	75	M	Aug 2002	ITP	48	Yes	—¶	Yes	Yes
4	25	F	Sep 2003	ITP	50	—∥	—¶	Yes	Yes
5	71	F	Sep 2004	ITP	75	Yes	—¶	Yes	Yes
6	67	M	Oct 2004	ITP	51	Yes	—¶	Yes	Yes

— indicates no information available.

Signs or symptoms within 4 hours of anti-D IGIV administration.

†

Increased serum hemoglobin level or anecdotal report of “visibly red serum” (or similar terms).

‡

Positive urine reagent strip test for blood and urinary sediment with fewer RBCs than would correspond to degree of positivity of reagent strip or anecdotal report of “tea-colored urine” (or similar terms).

Attending or consulting physician assessment that hemoglobinemia or hemoglobinuria occurred.

∥

Exact time of onset indeterminate due to incomplete medical history.

Relevant laboratory test results not available or not optimally timed.

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