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Resource Profile: NonComparativeEvidence - Examples

Page standards status: Trial-use

Maturity Level: 1

Lloyd: StructureDefinition-non-comparative-evidence.html;Resource Profile;Resource

Examples for the non-comparative-evidence Profile.

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Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration for Glucagon Nasal Powder in NCT03421379

Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379

Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379

Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379

PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379

PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379

Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379

Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379

PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379

PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379

PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379

PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379

Change in Mean Systolic Blood Pressure at 12 weeks for QUARTET LDQT in NCT03640312

Change in Mean Systolic Blood Pressure at 12 weeks for Candesartan in NCT03640312

Mean Systolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312

Mean Systolic Blood Pressure at 6 weeks for Candesartan in NCT03640312

Change in Mean Diastolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312

Change in Mean Diastolic Blood Pressure at 6 weeks for Candesartan in NCT03640312

Mean Diastolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312

Mean Diastolic Blood Pressure at 6 weeks for Candesartan in NCT03640312

Proportion of Patients With Hypertension Control at 6 and 12 weeks - 6 weeks for QUARTET LDQT in NCT03640312

Proportion of Patients With Hypertension Control at 6 and 12 weeks - 6 weeks for Candesartan in NCT03640312

Proportion of Patients With Hypertension Control at 6 and 12 weeks - 12 weeks for QUARTET LDQT in NCT03640312

Proportion of Patients With Hypertension Control at 6 and 12 weeks - 12 weeks for Candesartan in NCT03640312

Number of Patients Requiring Step up Treatment at 6 weeks for QUARTET LDQT in NCT03640312

Number of Patients Requiring Step up Treatment at 6 weeks for Candesartan in NCT03640312

Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks for QUARTET LDQT in NCT03640312

Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks for Candesartan in NCT03640312

Medication Adherence at 12 weeks for QUARTET LDQT in NCT03640312

Medication Adherence at 12 weeks for Candesartan in NCT03640312

Health-related Quality of Life at 12 weeks - Change in Physical Health T score (PROMIS) for QUARTET LDQT in NCT03640312

Health-related Quality of Life at 12 weeks - Change in Physical Health T score (PROMIS) for Candesartan in NCT03640312

Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for QUARTET LDQT in NCT03640312

Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for Candesartan in NCT03640312

Change in Mean Systolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312

Change in Mean Systolic Blood Pressure at 6 weeks for Candesartan in NCT03640312

Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312

Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for Candesartan in NCT03640312

Percentage of Participants With Potentially Related Adverse Events at 12 weeks for QUARTET LDQT in NCT03640312

Percentage of Participants With Potentially Related Adverse Events at 12 weeks for Candesartan in NCT03640312

Rate of Adverse Events of Special Interest at 12 weeks for QUARTET LDQT in NCT03640312

Rate of Adverse Events of Special Interest at 12 weeks for Candesartan in NCT03640312

Mean Change in Serum Potassium at 12 weeks for QUARTET LDQT in NCT03640312

Mean Change in Serum Potassium at 12 weeks for Candesartan in NCT03640312

Mean Change in Serum Sodium at 12 weeks for QUARTET LDQT in NCT03640312

Mean Change in Serum Sodium at 12 weeks for Candesartan in NCT03640312

Mean Change in Blood Urea Nitrogen at 12 weeks for QUARTET LDQT in NCT03640312

Mean Change in Blood Urea Nitrogen at 12 weeks for Candesartan in NCT03640312

Mean Change in Serum Creatinine at 12 weeks for QUARTET LDQT in NCT03640312

Mean Change in Serum Creatinine at 12 weeks for Candesartan in NCT03640312

Evidence for Results for Medication Adherence at 12 weeks in QUARTET USA Trial Quadpill group