Patients with:
|
Total sample N = 761
|
OM N = 186
|
LM N = 152
|
AM N = 216
|
OLC N = 47
|
OAC N = 68
|
OC N = 48
|
OMS N = 44
|
---|
N
|
%
|
N
|
%
|
N
|
%
|
N
|
%
|
N
|
%
|
N
|
%
|
N
|
%
|
N
|
%
|
---|
Any TEAE
|
113
|
14.9
|
21
|
11.3
|
27
|
17.8
|
31
|
14.4
|
9
|
19.2
|
8
|
11.8
|
7
|
14.6
|
10
|
22.7
|
Related TEAE
|
78
|
10.3
|
14
|
7.5
|
19
|
12.5
|
23
|
10.7
|
6
|
12.8
|
6
|
8.8
|
3
|
6.3
|
7
|
15.9
|
Any SAE
|
8
|
1.1
|
0
|
0.0
|
3
|
2.0
|
1
|
0.5
|
1
|
2.1
|
0
|
0.0
|
2
|
4.2
|
1
|
2.3
|
Related SAE
|
1
|
0.1
|
0
|
0.0
|
1
|
0.7
|
0
|
0.0
|
0
|
0.0
|
0
|
0.0
|
0
|
0.0
|
0
|
0.0
|
TEAE leading to discontinuation
|
7
|
0.9
|
0
|
0.0
|
2
|
1.3
|
1
|
0.5
|
1
|
2.1
|
0
|
0.0
|
2
|
4.2
|
1
|
2.3
|
Lethal outcome
|
4
|
0.5
|
0
|
0.0
|
0
|
0.0
|
1
|
0.5
|
1
|
2.1
|
0
|
0.0
|
2
|
4.2
|
0
|
0.0
|
- Abbreviations: N number of patients, OM Olanzapine monotherapy, LM Lithium monotherapy, AM Anticonvulsive monotherapy, OLC Olanzapine/lithium combination therapy, OAC Olanzapine/anticonvulsive combination therapy, OC Other combinations of mood-stabilizers, OMS Other mood stabilizing therapy, TEAE treatment emergent adverse events, SAE serious adverse events.