Table 2.
Summary of Secondary Efficacy Outcomes at Week 8, Intent-to-Treat Population
| CGI-S | N | Adjusted mean change (SE) | Difference in adjusted means (placebo active) | 95% CI | p |
|---|---|---|---|---|---|
| Placebo | 102 | −1.49 (0.11) | |||
| Desvenlafaxine low exposure | 105 | −1.51 (0.11) | 0.015 | −0.29, 0.32 | 0.923 |
| Desvenlafaxine high exposure | 106 | −1.65 (0.11) | 0.161 | −0.14, 0.47 | 0.302 |
| CGI-Ia | N | Very much improved (%) | Much improved (%) | Minimally improved (%) | No change (%) | CMH test p-value |
|---|---|---|---|---|---|---|
| Placebo | 102 | 22 (21.6) | 35 (34.3) | 29 (28.4) | 16 (15.7) | |
| Desvenlafaxine low exposure | 105 | 20 (19.0) | 39 (37.1) | 26 (24.8) | 19 (18.1) | 0.696 |
| Desvenlafaxine high exposure | 106 | 27 (25.5) | 39 (36.8) | 23 (21.7) | 16 (15.1) | 0.462 |
| CGI-I responseb | Proportion responders | % | Adjusted odds ratio | Wald 95% CI | p |
|---|---|---|---|---|---|
| Placebo | 57/102 | 55.9 | |||
| Desvenlafaxine low exposure | 59/105 | 56.2 | 0.97 | 0.56, 1.69 | 0.925 |
| Desvenlafaxine high exposure | 66/106 | 62.3 | 0.76 | 0.44, 1.33 | 0.342 |
a
CGI-I scored as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; 7, very much worse; 1 patient in each desvenlafaxine group scored 5 at week 8 and no patient scored 6 or 7 at week 8.
b
CGI-I response was defined as CGI-I score of 1 (very much improved) or 2 (much improved).
CGI-I, Clinical Global Impressions-Improvement; CGI-S, Clinical Global Impressions-Severity; CI, confidence interval; CMH, Cochran-Mantel-Haenszel; SE, standard error.