AT PATIENT LEVEL Sample Clauses

AT PATIENT LEVEL. 10.1.1 Decision to slow down or stop NI-0501 infusion due to systemic reaction During the infusion of NI-0501, any significant change compared to pre-infusion values in xxxxx xxxxx, such as those listed below, should trigger appropriate immediate care: • Sudden and sustained increase or paradoxical decrease of heart rate (duration of more than 1 minute) compared to pre-infusion value • Respiratory rate abnormality (significant change compared to measure prior to infusion) • Blood pressure drop or peak compared to the value prior to infusion for at least 2 consecutive measurements • Significant skin modifications (change in color or abundant sweating) • Sustained (an episode of more than 3 minutes duration or more than 3 episodes of shorter duration i.e. 1 minute) oxygen desaturation (below 90%) The decision to slow down the infusion will be taken by the physician in the event of any of the above mentioned occurrences. The decision to stop the infusion will be based on the evolution of patient status after appropriate symptomatic measures, e.g. oxygenation, and upon physician’s own medical judgment. All changes in infusion rate will be recorded in the eCRF: each time with a rate modification as well as end of the premature or delayed termination of the infusion.
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