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Body weight expressed as percentage change from baseline was calculated at the end of the study period (or earlier in the event of earlier death).
The average percentage change from baseline was calculated at each post-baseline evaluation visit.
BCVA and CRT were reviewed for 6 months, and the change from baseline was calculated at each follow-up visit.
Mean change in visual acuity from baseline was calculated at the first and second year of the study.
The group mean score for standard care midwives in the personal burnout subscale at baseline was calculated at 50, indicating that as a group, midwives working in standard care were close to burnout according to the CBI.
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The variable 'PFI' at baseline was calculated as time between last dose of prior platinum and progression before the start of protocol therapy (either PLD or trabectedin/PLD).
Respondents exceeding the diagnostic threshold value at the baseline time point (depressive symptoms at baseline were calculated at day 14) were excluded from this analysis.
Summary statistics of absolute scores of the PRO end points and their changes from baseline were calculated at each assessment time point for the two treatments.
For both BASDAI and spine pain, the number and percentage of patients achieving ≥15%, ≥30 %, ≥50, and ≥70% improvement from bandline were calculated at Weeks 2, 4, and 6 and these values were used to determine the corresponding NNTs.
Statistical analyses of clinical data were performed using SAS software (Version 6 09; SAS Institute Inc ,Cary, NC, USA).Walking distance, LVEF, and cardiothoracic ratio were measured at baseline, and changes from baseline were calculated at each subsequent time point (walking distance, Days 8 and 30; LVEF and cardiothoracic ratio, Day 30).
For each patient the difference in FMD at 6 month and baseline was calculated (FMD value at 6 months − FMD value at baseline).
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