Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

To determine the incidence of any treatment emergent AE; using using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Targeted toxicities include hypotension; skin rash. These will be coded at all timepoints by both the clinician and the clinical trial manager in terms of causality.[CTCAE v5.0 will be completed and assessed daily until the patient is no longer on trial; that is 7 days or until discharge; whichever is longer. The primary endpoint will be assessed days 1-7; but in this study all time points will be assessed during analysis.];Incidence of Blood Pressure toxicity; defined as systolic BP readings < 100mmHg that do not return to baseline within 24 hours will be measured as per standard local hospital practice (digital or manual sphygmomanometer); and required to be measured at least daily (once in 24 hours).[The incidence will be assessed daily until patient no longer on trial; that is 7 days or until discharge; whichever is longer. The primary endpoint will be assessed days 1-7; but in this study all time points will be assessed during analysis.]

To determine the incidence of any treatment emergent AE; using using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Targeted toxicities include hypotension; skin rash. These will be coded at all timepoints by both the clinician and the clinical trial manager in terms of causality.[CTCAE v5.0 will be completed and assessed daily until the patient is no longer on trial; that is 7 days or until discharge; whichever is longer. The primary endpoint will be assessed days 1-7; but in this study all time points will be assessed during analysis.];Incidence of Blood Pressure toxicity; defined as systolic BP readings < 100mmHg that do not return to baseline within 24 hours will be measured as per standard local hospital practice (digital or manual sphygmomanometer); and required to be measured at least daily (once in 24 hours).[The incidence will be assessed daily until patient no longer on trial; that is 7 days or until discharge; whichever is longer. The primary endpoint will be assessed days 1-7; but in this study all time points will be assessed during analysis.]