Table 1. Thrombocytopenia and DDAB... | American Society of Hematology

Table 1.

Thrombocytopenia and DDAB status in clinical trials of roxifiban

Subject no.	Nadir platelet count, ×10³/μL	Day of thrombocytopenia	DDABs prior to treatment	DDABs at time of thrombocytopenia
Retrospective testing for DDABs
304	15	4	No sample	No sample
503	122	3	No sample	No sample
10 205^*	47	3	No	No
10 403^*	79	2	Yes	Yes
307^†	BQL	11	Yes	Yes
330^†	59	16	No	Yes
55 202^*	35	13	Yes	Yes
58 204^*	5	14	Yes	Yes

Prospective testing for DDABs
99016	2	14	Yes	Yes
21013	8	11	No	Yes

Subject no.	Nadir platelet count, ×10³/μL	Day of thrombocytopenia	DDABs prior to treatment	DDABs at time of thrombocytopenia
Retrospective testing for DDABs
304	15	4	No sample	No sample
503	122	3	No sample	No sample
10 205^*	47	3	No	No
10 403^*	79	2	Yes	Yes
307^†	BQL	11	Yes	Yes
330^†	59	16	No	Yes
55 202^*	35	13	Yes	Yes
58 204^*	5	14	Yes	Yes

Prospective testing for DDABs
99016	2	14	Yes	Yes
21013	8	11	No	Yes

Thrombocytopenia is defined as platelet number below 90 000/μL or reduction by more than 50% compared with the predose specimen.

Nadir indicates platelet count per microliter during thrombocytopenia; day, earliest time point thrombocytopenia definition was met; no, DDAB concentration below the medical decision limit; yes, DDAB concentration above the medical decision limit; and BQL, below quantifiable limits.

Thrombocytopenia cases during a PAD clinical trial. The remainder of the cases were derived from CAD clinical trials.

†

These patients have been described previously.13

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