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Table 4 Laboratory findings to be reported to the sponsor within a maximum of 7 days

From: Prevention of Morbidity in sickle cell disease - qualitative outcomes, pain and quality of life in a randomised cross-over pilot trial of overnight supplementary oxygen and auto-adjusting continuous positive airways pressure (POMS2a): study protocol for a randomised controlled trial

Variables

Measurement level that may be consider as adverse events

Haemoglobin

Fall of > 20 g/l from baseline is significant

Reticulocytes

10–100 x 109 fall < 10 × 109 is significant

Lactate dehydrogenase

Increase of > 1.5 x from baseline is significant.

Bilirubin

Increase of > 1.5 x from baseline is significant

Creatinine

Increase of > 1.5 from baseline is significant

Erythropoeitin

Fall of > 50 % from baseline is significant

Oximetry

Decrease in baseline oximetry of > 3 % from baseline