Table 1.
Visit | Mean PANSS-FSNS change from baseline (n) at the 1st instance of minimal improvement [1] | Mean PANSS-FSNS change from baseline (n) at the last recorded unchanged status [2] | MCID1 [1] | MCID2 [1]-[2] | SD of [1] and [2] | LSMD (95% CI) | P-value |
---|---|---|---|---|---|---|---|
Overall | −3.8 (365) |
−2.3 | −3.8 (18.5%) |
−1.5 (7.3%) |
2.5 | 1.7 (1.1, 2.3) |
<0.0001 |
PANSS-FSNS, Positive and Negative Syndrome Scale-Factor Score for Negative Symptoms; n, number of events; CGI-I, Clinical Global Impression—Improvement; MCID1 and MCID2, Minimum clinically important differences according to the definitions in the text; SD, Standard deviation; LSMD, Least-square mean difference between [1] and [2], as estimated by MMRM, with corresponding 95% confidence limits. Please also note that for the computation of % changes from baseline the value of 7 was subtracted from the observed baseline severity (i.e., 27.6) since the minimum value of the PANSS-FSNS factor is 7 (i.e., the symptoms on all seven constituting items of the factor are rated as “Absent”).