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Table 1 Incidence of AEs during the AOM 400 maintenance phase

From: Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study

AE, n (%)

De novo, n = 379

Rollover, n = 85

Total, N = 464

TEAEs

323 (85.2)

51 (60.0)

374 (80.6)

Serious TEAEs

27 (7.1)

3 (3.5)

30 (6.5)

Nonserious TEAEs

318 (83.9)

49 (57.6)

367 (79.1)

Severe TEAEs

39 (10.3)

2 (2.4)

41 (8.8)

Discontinued AOM 400 due to TEAEs

44 (11.6)

3 (3.5)

47 (10.1)

Discontinued AOM 400 due to AE/death

45 (11.9)

3 (3.5)

48 (10.3)

Deaths

1 (0.3)

0

1 (0.2)

  1. AE adverse event, AOM 400 aripiprazole once-monthly 400 mg, TEAE treatment-emergent AE