. 2017 Jun 1;27(3):121–129. doi: 10.1089/nat.2016.0650

Table 4.

Incidence of Confirmed Postbaseline Platelet Reductions with Mipomersen Treatment

	Total phase 3 RCT		6-Month phase 3 RCT		1-Year phase 3 RCT
Post-BSLN platelet counts Confirmed,^a n (%)	Placebo total	MIPO total	Placebo	MIPO	Placebo	MIPO
n^b	221	433	121	249	100	184
LLN-100 K/μL	6 (2.7)	27 (6.2)	5 (4.1)	16 (6.4)	1 (1.0)	11 (6.0)
<100–75 K/μL	0 (0)	1 (0.2)	0 (0)	0 (0)	0 (0)	1 (0.5)
<75–50 K/μL	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
<50–25 K/μL	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
<25 K/μL	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)

^{^a}

Confirmed was defined as a consecutive (next) abnormal laboratory value after the initial observation. If there was no consecutive test to confirm, then the initial observation was presumed confirmed.

^{^b}

Number of subjects with normal BSLN platelet counts and with post-BSLN values. Lowest confirmed category was reported for each subject.

MIPO, mipomersen; RCT, randomized placebo-controlled trial.