Presentation is loading. Please wait.

Presentation is loading. Please wait.

ITT populations EASTERN: n=216 WESTERN: n=234 Randomized to asenapine and received  1 treatment EASTERN: n=241 WESTERN: n=244 Randomized to olanzapine.

Similar presentations


Presentation on theme: "ITT populations EASTERN: n=216 WESTERN: n=234 Randomized to asenapine and received  1 treatment EASTERN: n=241 WESTERN: n=244 Randomized to olanzapine."— Presentation transcript:

1 ITT populations EASTERN: n=216 WESTERN: n=234 Randomized to asenapine and received  1 treatment EASTERN: n=241 WESTERN: n=244 Randomized to olanzapine and received  1 treatment EASTERN: n=240 WESTERN: n=224 EASTERN WESTERN Discontinuations 85 (35.3%) 123 (50.4%) AEs* 36 (14.9%) 42 (17.2%) Worsening symptoms 22 (9.1%) 25 (10.2%) Other 14 (5.8%) 17 (7.0%) Lack of efficacy 7 (2.9%) 12 (4.9%) Withdrew consent 31 (12.9%) 32 (13.1%) Lost to follow-up 4 (1.7%) 12 (4.9%) Other 7 (2.9%) 25 (10.2%) Completed 26-weeks of treatment EASTERN: n=156 (64.7%) WESTERN: n=121 (49.6%) ITT populations EASTERN: n=217 WESTERN: n=218 Screened subjects EASTERN (N=576) WESTERN (N=803) ITT populations EASTERN: n=122 WESTERN: n=83 Entered 26-week extension and received  1 treatment EASTERN: n=134 WESTERN: n=86 and 85 Entered 26-week extension and received  1 treatment EASTERN: n=172 WESTERN: n=110 Completed 52 weeks of treatment † EASTERN: n=113 (84.3%) WESTERN: n=57 (66.3%) ITT populations EASTERN: n=157 WESTERN: n=110 Completed 26 weeks of treatment EASTERN: n=193 (80.4%) WESTERN: n=143 (63.8%) Completed 52 weeks of treatment † EASTERN: n=153 (89.0%) WESTERN: n=89 (80.9%) 26-Week Core Studies 26-Week Extension Studies EASTERN WESTERN Discontinuations 47 (19.6%) 81 (36.2%) AEs* 18 (7.5%) 30 (13.4%) Worsening symptoms 6 (2.5%) 16 (7.1%) Other 12 (5.0%) 14 (6.3%) Lack of efficacy 5 (2.1%) 7 (3.1%) Withdrew consent 19 (7.9%) 26 (11.6%) Lost to follow-up 1 (0.4%) 5 (2.2%) Other 4 (1.7%) 13 (5.8%) Excluded, nonrandomized EASTERN (n=95) WESTERN (n=335) EASTERN WESTERN Discontinuations 21 (15.7%) 29 (33.7%) AEs* 10 (7.5%) 7 (8.1%) Worsening symptoms 5 (3.7%) 5 (5.8%) Other 5 (3.7%) 2 (2.3%) Lack of efficacy 0 (0.0%) 2 (2.3%) Withdrew consent 3 (2.2%) 3 (3.5%) Lost to follow-up 0 (0.0%) 1 (1.2%) Other 8 (6.0%) 16 (18.6%) EASTERN WESTERN Discontinuations 19 (11.0%) 21 (19.1%) AEs* 7 (4.1%) 4 (3.6%) Worsening symptoms 3 (1.7%) 1 (0.9%) Other 4 (2.3%) 3 (2.7%) Lack of efficacy 0 (0.0%) 2 (1.8%) Withdrew consent 9 (5.2%) 5 (4.5%) Lost to follow-up 0 (0.0%) 0 (0.0%) Other 3 (1.7%) 10 (9.1%) Supplementary Figure A Disposition of subjects. AE=adverse events; ITT=intent-to-treat populations (received  1 dose of study medication and had  1 post-baseline primary efficacy assessment). *Discontinuations due to AEs based on end-of-treatment disposition forms; compare to Table 4, showing discontinuations due to AEs based on AE reporting forms. (If the subject’s condition remained the same within the scope of the illness, it was documented as ‘Lack of efficacy’ as reason for discontinuation and not documented as an AE or AE as a reason for discontinuation. If the subject’s condition worsened outside the scope of their illness, it was documented as an AE or AE as a reason for discontinuation.) † Based on number of subjects entering the respective extension study. Countries in which these studies were conducted: EH studies (Australia, the Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russia, South Africa, Spain, Sweden, and the United Kingdom); WH studies (Brazil, Canada, Chile, Mexico, and the United States).


Download ppt "ITT populations EASTERN: n=216 WESTERN: n=234 Randomized to asenapine and received  1 treatment EASTERN: n=241 WESTERN: n=244 Randomized to olanzapine."

Similar presentations


Ads by Google