Equipercentile linking is used to examine extrapolation (a) from CGI-S to PANSS severity ratings and (b) from CGI-I to PANSS percentage change (n = 2698). Linking is conducted at baseline and after 2, 4, 6 and 8 weeks of treatment from ITT clinical trial participants with schizophrenia.
Across weeks 2, 4, 6 and 8, being considered x2018;not illx2019; according to the CGI-S corresponded to PANSS scores of 31x2013;2. The relationship between the CGI-S and the PANSS followed an increasing trend, such that x2018;very mildx2019; corresponded with 41x2013;7, x2018;mildx2019; corresponded with 55x2013;62, x2018;moderatex2019; corresponded with 71x2013;7, x2018;markedx2019; corresponded with 88x2013;94, x2018;severex2019; corresponded with 105x2013;110, and x2018;extremely severex2019; corresponded with 126x2013;134. The relationship between CGI-I ratings and percentage change followed a linear trend, such that x2018;very much improvedx2019; corresponded to PANSS percentage change scores from 79 to 75, x2018;much improvedx2019; corresponded with 45 to 49, x2018;minimally improvedx2019; corresponded with 21 to 23, x2018;unchangedx2019; corresponded with 2 to 3, x2018;minimally worsex2019; corresponded with − 15 to − 20, x2018;much worsex2019; corresponded with − 44 to − 51. Generally, within the trials the cut-off ranges identified overlapped within around 10 points of those found in the pooled analysis.
Despite trial heterogeneity, the results support the extrapolation from the CGI-I to PANSS percentage change. Extrapolation of the CGI-S to the PANSS is observed, except in the case of severe symptomatology which is rare. Collectively, the results support the extrapolation between the PANSS and CGI.
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