187 Hydrocortisone as an intervention (RCT) 6 The median delta PedsQL score (n = 41) was −14 points (IQR −24 to −4) during hydrocortisone and −15 points (−26 to −7) during placebo, a difference which was not statistically significant (Figure 4c, Supplemental Tables 4 and 7). The delta distress thermometer score (n = 40) was 2 (IQR 1–4) during ‘dexamethasone only’ and the hydrocortisone and placebo courses, no difference between hydrocortisone and placebo in reducing parental distress was found (Figure 4d, Supplemental Tables 4 and 8). Adverse Events All adverse events (AEs) are depicted in Supplemental Table 9. Overall, adverse events were usually minor (grade 1 or 2) and equally divided between hydrocortisone and placebo periods. Most serious adverse events (SAEs) were scored as being related to leukemia treatment (Supplemental Table 10). However, one patient left the study during the third study course due to abnormal behavior (CTCAE grade 2). The mother described that her daughter became angry, delusional and associative after starting study medication. Therefore, after 2.5 days, her study medication was discontinued, her behavior normalized, and deblinding took place for this patient. The study medication was hydrocortisone, and the episode was reported as an SAE, possibly related to the study medication.
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