Absolute neutrophil count less than 0.5×10(9)/L and Liver transaminases >8 times the upper limit of the normal range are exclusion criteria for Baricitinib. If patients are within range at the start of treatment but deviate from this range during treatment, would we withdraw the treatment?

No this does not automatically require the study drug to be stopped. The stopping criteria are:

•     Serious Adverse Event related to the study drug

•     Allergic reaction to IMP

•     Decision from the attending ICU physician that the study drug should be discontinued on safety grounds.

•     If the investigator considers that a participant’s health will be compromised due to adverse events or concomitant illness that develop after entering the study.

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