All data, except for the PK parameters, were collected using an electronic data collection system (Viedoc) and analyzed by Intellim (Tokyo, Japan), an independent CRO. The primary full analysis set (FAS) included all patients who had completed 14 days of administration of the test drug. The population included in the safety analysis were all patients who received at least 1 day of administration of the test drug. Changes in Mayo scores, Lichtiger index, MES, fecal calprotectin, and FIT, as well as dose of steroid, were analyzed using unpaired t test and analysis of variance (ANOVA) followed by Fisher’s multiple comparison test. The clinical remission rate and response rate were analyzed using chi-square analysis. The significant level for each test was 5%. All analyses were performed using SAS version 9.3 (SAS Institute, Cary, NC, USA). The Cmax and Tmax values were obtained directly from the data, while the AUC was calculated using the Phoenix WinNonlin software 6·1 (Pharsight, CA, USA). All data are shown as mean ± standard deviation (SD).
Phoenix winnonlin software 6 1
Manufactured by Pharsight
Sourced in United States
Phoenix WinNonlin software 6.1 is a data analysis software developed by Pharsight. It is used for the analysis of pharmacokinetic and pharmacodynamic data.
Automatically generated - may contain errors
Lab products found in correlation
2 protocols using phoenix winnonlin software 6 1
1
Efficacy and Safety of Novel Ulcerative Colitis Treatment
2
Evaluating Novel Crohn's Disease Treatment
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All data, except for data that were processed at the Bozo Research Centre, were collected using an electronic data collection system (cubeCDMS) and analyzed by Intellim (Tokyo, Japan), an independent contract research organization. All 24 patients completed the 7‐day administration of the test drug; thus, all patients were included in the primary full analysis set (FAS) and the safety analysis. Changes in CDAI, SESCD, fecal calprotectin, FIT, and CRP were analyzed using an unpaired t‐test and analysis of variance (ANOVA), followed by Fisher's multiple comparison test. Clinical response rates were analyzed using chi‐square analysis and Fisher's exact test. The changes in CDAI from 0 to 24 weeks were analyzed using a mixed‐effects model. The significance level for each test was set at 5%. All analyses were performed using SAS version 9.3 (SAS Institute, Cary, NC, USA). The Cmax and Tmax values were obtained directly from the data, while the AUC was calculated using the Phoenix WinNonlin software 6.1 (Pharsight, CA, USA). All data are shown as mean ± standard deviation (SD).
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