|
Outcome
|
Frequency of significant outcomes1MMRM LOCF_ANCOVA
|
P-value lower with MMRM LOCF_ANCOVA
|
Outcome significant with MMRM but not LOCF_ANCOVA
|
Outcome significant with LOCF_ANCOVA but not MMRM
|
|---|
|
HAMD
17
| | | | | | |
|
Total score
|
9\12
|
6\12
|
9\12
|
1\12
|
3\12
|
0\12
|
|
Core subscale
|
9\12
|
8\12
|
5\12
|
3\12
|
2\12
|
1\12
|
|
Maier subscale
|
10\12
|
9\12
|
6\12
|
2\12
|
2\12
|
1\12
|
|
Anxiety subscale
|
6\12
|
5\12
|
7\12
|
3\12
|
2\12
|
1\12
|
|
Retardation subscale
|
8\12
|
6\12
|
6\12
|
3\12
|
4\12
|
2\12
|
|
Sleep subscale
|
1\12
|
1\12
|
10\12
|
2\12
|
0\12
|
0\12
|
|
MADRS Total score
|
5\10
|
3\10
|
7\10
|
2\10
|
2\10
|
0\10
|
|
HAMA Total score
|
3\10
|
3\10
|
4\10
|
5\10
|
0\10
|
0\10
|
|
CGI-Severity
|
6\12
|
6\12
|
8\12
|
2\12
|
0\12
|
0\12
|
|
CGI-Improvement
|
1\2
|
1\2
|
2\2
|
0\2
|
0\2
|
0\2
|
|
PGI-Improvement
|
9\12
|
7\12
|
8\12
|
2\12
|
2\12
|
0\12
|
|
Somatic Symptom Inventory
| | | | | | |
|
26-item Average score
|
2\10
|
2\10
|
7\10
|
3\10
|
0\10
|
0\10
|
|
28-item Average score
|
3\10
|
2\10
|
7\10
|
3\10
|
1\10
|
0\10
|
|
VAS Pain Severity
| | | | | | |
|
Overall pain
|
3\10
|
4\10
|
2\10
|
8\10
|
1\10
|
2\10
|
|
Headaches
|
1\10
|
0\10
|
5\10
|
5\10
|
1\10
|
0\10
|
|
Back pain
|
2\10
|
2\10
|
6\10
|
4\10
|
1\10
|
1\10
|
|
Shoulder pain
|
2\10
|
1\10
|
3\10
|
6\10
|
2\10
|
1\10
|
|
Daily activities
|
1\10
|
0\10
|
2\10
|
8\10
|
1\10
|
0\10
|
|
Pain while awake
|
2\10
|
2\10
|
5\10
|
5\10
|
1\10
|
1\10
|
|
QLDS Total score
|
1\4
|
2/4
|
1\4
|
2\4
|
0\4
|
1\4
|
|
Totals
|
84\202
|
70\202
|
110\202
|
69\202
|
25\202
|
11\202
|
- 1. Some of the eight trials included more than one dose arm. Therefore, an individual outcome could be assessed in as many as 12 comparisons with placebo.
