Figure 1.

Detailed flow diagram for the cohort.

Abbreviations: HRQL, health-related quality of life; PedsQLTM, Pediatric Quality of Life Inventory; FSII-R, Stein-Jessop Functional Status Scale; N, total number of patients with available, adequate, change from baseline survey data at a particular time point; CFB, change from baseline; PSD-HRQL, persistent, severe deterioration of HRQL below baseline, specifically, HRQL scores (PedsQLTM or FSII-R) persisting > 25% below the baseline HRQL assessment at follow-up; D, cumulative deaths among the entire LAPSE clinical cohort (n=389). Seven of the 35 patients who died in the hospital did so after the Day 28 study time point. Two subjects where discharged from the hospital alive before Day 28, but died later during the Day 28 time point interval; ΣPSD-HRQL, total patients with persistent, severe deterioration of HRQL below baseline from PedsQLTM or FSII-R cohorts.

1 No clinical data was available due to early family-initiated withdrawal from the study or refusal to complete HRQL surveys.

2 Families never initiated a survey, even the baseline survey, or surveys were inadequately completed and could not be used for analysis.