Trial Outcomes & Findings for Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia (NCT NCT03852537)

NCT ID: NCT03852537

Last Updated: 2021-09-16

Results Overview

Number of eligible subjects to adhered to the timely initiation and daily corticosteroid treatment according to ESICM/Society of Critical Care Medicine SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 44 participants
• Primary outcome timeframe: Within 30 days of enrollment in study.
• Results posted on: 2021-09-16

Participant Flow

Participant milestones

Measure	Usual Care Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Overall Study STARTED	23	21
Overall Study COMPLETED	23	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia

Baseline characteristics by cohort

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.	Total n=44 Participants Total of all reporting groups
Age, Continuous	60.0 years n=5 Participants	59.0 years n=7 Participants	60.0 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	21 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 days of enrollment in study.

Number of eligible subjects to adhered to the timely initiation and daily corticosteroid treatment according to ESICM/Society of Critical Care Medicine SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing	20 Participants	19 Participants

SECONDARY outcome

Timeframe: 90 days

Number of subject deaths

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Mortality	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Number of subjects to need high flow nasal cannula oxygen

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Need for High Flow Nasal Cannula Oxygen	7 Participants	4 Participants

SECONDARY outcome

Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Assessed by the number of participants that required noninvasive mechanical ventilation.

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Need for Noninvasive Mechanical Ventilation	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Assessed by the number of participants that required invasive mechanical ventilation.

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Need for Invasive Mechanical Ventilation	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Measured daily for approximately 5 days

Organ failures measured by Sequential Organ Failure Assessment (SOFA). The overall score is based on 6 sub-scores respiratory system, neurologic system, cardiovascular system, hepatic system, coagulation, and renal system using an overall scale of 0-24, which 0=no organ failure, 24=complete organ failure.

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Organ Failure Day 5	3.0 score on a scale Interval 2.0 to 5.0	5.5 score on a scale Interval 3.0 to 8.0
Organ Failure Day 1	3.0 score on a scale Interval 3.0 to 6.0	7.0 score on a scale Interval 4.0 to 9.0
Organ Failure Day 2	3.0 score on a scale Interval 3.0 to 3.0	3.0 score on a scale Interval 2.0 to 6.0
Organ Failure Day 3	3.0 score on a scale Interval 3.0 to 4.0	3.0 score on a scale Interval 2.0 to 5.5
Organ Failure Day 4	3.0 score on a scale Interval 3.0 to 5.0	3.0 score on a scale Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Number of participants who develop arrhythmias identified by electrocardiogram or echocardiogram.

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
New Onset Cardiac Arrhythmias	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to day +14 following study enrollment.

Population: Data were missing for 8 subjects in the usual care arm and 4 subjects in the biomarker-adjusted steroid dosing arm.

Number of participants with evidence of myocardial injury determined by daily troponin peak and /or new diagnosis of Left Ventricular (LV) dysfunction (LVEF <40%) or new diagnosis of cor pulmonale

Outcome measures

Measure	Usual Care n=15 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=17 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Myocardial Injury	8 Participants	10 Participants

SECONDARY outcome

Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Number of subjects with new and/or worsening right ventricle (RV)/left ventricle (LV) dysfunction

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Cardiovascular Dysfunction	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to day +5 following study enrollment.

Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration.

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Occurrence of Hyperglycemia	11 Participants	18 Participants

SECONDARY outcome

Timeframe: Up to day +5 following study enrollment.

Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium.

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Occurrence of Delirium	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to day +14 following study enrollment.

Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued.

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Occurrence of Secondary Infection	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Number of subjects admitted to the ICU

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
ICU Admission	10 Participants	5 Participants

SECONDARY outcome

Timeframe: Within hospitalization or 30 days of study enrollment (whichever is sooner)

Number of days subjects did not require oxygen assistance.

Outcome measures

Measure	Usual Care n=23 Participants Corticosteroid use and dosing determined by the patient's primary team for standard of care. Usual Care: Corticosteroid use and dosing determined by the patients treatment team for standard of care.	Biomarker-adjusted Steroid Dosing n=21 Participants Individualized, biomarker concordant steroid use: dosing, titration and duration according to CRP level. This is a predetermined dosing table that adjusts dose of steroid by CRP level. Specifically: if CRP \< 50 mmol/L: discontinue steroid; if CRP is between 51-100 mmol/L: 0.5 mg methylprednisolone (or dose equivalent of oral prednisone); if CRP is between 101-150 mmol/L: 0.75 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level is between 151-200 mmol/L: 1 mg/kg methylprednisolone (or dose equivalent of oral prednisone); if CRP level \> 200 mmol/L: 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone). Methylprednisolone: Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
Oxygen-free Days	21.0 days Interval 17.0 to 25.0	24.0 days Interval 22.0 to 25.5

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Biomarker-adjusted Steroid Dosing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hemang Yadav, MBBS, MS

Mayo Clinic

Phone: 507-266-3958

Email: Yadav.Hemang@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place