Table 1 Overview of TEAEs for the safety analysis period

From: Pepinemab antibody blockade of SEMA4D in early Huntington’s disease: a randomized, placebo-controlled, phase 2 trial

Category

Cohort B1, n = 179

Cohort B2, n = 86

Cohort B, overall n = 265

PBO, n = 87

PEPI, n = 92

PBO, n = 45

PEPI, n = 41

PBO, n = 132

PEPI, n = 133

Subjects with ≥1 TEAE, n (%)a

82 (94%)

84 (91%)

41 (91%)

41 (100%)

123 (93%)

125 (94%)

Probably or definitely relatedb

10 (11%)

16 (17%)

9 (20%)

17 (41%)

19 (14%)

33 (25%)

Study drug discontinuation

2 (2%)

5 (5%)

1 (2%)

0

3 (2%)

5 (4%)

Serious TEAE

8 (9%)

4 (4%)

4 (9%)

2 (5%)

12 (9%)

6 (5%)

Probably/definitely relatedb

0

0

0

0

0

0

Grade ≥3 TEAEc

14 (16%)

17 (18%)

6 (13%)

8 (20%)

20 (15%)

25 (19%)

  1. Column header counts are the number of subjects in the safety population; TEAEs are those that occurred during the safety analysis period with onset on or after the date of the first exposure to study drug (PEPI or PBO).
  2. aSubjects are counted at most once in each cell, regardless of the number of events they may have had; denominators are the number of subjects in the safety population, unless otherwise specified.
  3. bRelatedness to study drug is defined as any of attribution of probable or definite as reported by the investigator.
  4. cGrade ≥3 refers to any severe, life-threatening or fatal event.
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