Trial Outcomes & Findings for Envarsus in Delayed Graft Function (E-DGF) (NCT NCT03864926)

Last Updated: 2023-07-20

Results Overview

The primary endpoint of the study will be the length of time between first dialysis and last dialysis after kidney transplant (duration of DGF).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

up to 3 months post transplant

Results posted on

2023-07-20

Participant Flow

Participants were recruited from the University of Wisconsin Hospital and Clinics between March 2019 and April 2022.

Participant milestones

Participant milestones
Measure	Standard of Care Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients. Dosage was clinically determined, dose form was oral tablets, and SOC tacrolimus was twice daily	Experimental Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day. Envarsus XR, a calcineurin-inhibitor immunosuppressant, is available for oral administration as extended-release tablets containing the equivalent of 0.75 mg, 1 mg, or 4 mg of anhydrous tacrolimus USP. Inactive ingredients include hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF. Tacrolimus is the active ingredient in ENVARSUS XR. Dosage was clinically determined, dose form was oral tablets, and experimental envarsus was once daily
Overall Study STARTED	50	50
Overall Study COMPLETED	50	48
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients. Dosage was clinically determined, dose form was oral tablets, and SOC tacrolimus was twice daily	Experimental Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day. Envarsus XR, a calcineurin-inhibitor immunosuppressant, is available for oral administration as extended-release tablets containing the equivalent of 0.75 mg, 1 mg, or 4 mg of anhydrous tacrolimus USP. Inactive ingredients include hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF. Tacrolimus is the active ingredient in ENVARSUS XR. Dosage was clinically determined, dose form was oral tablets, and experimental envarsus was once daily
Overall Study Death	0	2

Baseline Characteristics

Envarsus in Delayed Graft Function (E-DGF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=50 Participants Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.	Experimental n=50 Participants Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day.	Total n=100 Participants Total of all reporting groups
Age, Customized 30-39 years	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Age, Customized 40-49 years	8 Participants n=99 Participants	11 Participants n=107 Participants	19 Participants n=206 Participants
Age, Customized 50-59 years	21 Participants n=99 Participants	10 Participants n=107 Participants	31 Participants n=206 Participants
Age, Customized 60-69 years	12 Participants n=99 Participants	17 Participants n=107 Participants	29 Participants n=206 Participants
Age, Customized 70-79 years	4 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Female	19 Participants n=99 Participants	12 Participants n=107 Participants	31 Participants n=206 Participants
Sex: Female, Male Male	31 Participants n=99 Participants	38 Participants n=107 Participants	69 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=99 Participants	45 Participants n=107 Participants	92 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	15 Participants n=99 Participants	15 Participants n=107 Participants	30 Participants n=206 Participants
Race (NIH/OMB) White	29 Participants n=99 Participants	32 Participants n=107 Participants	61 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	50 Participants n=99 Participants	50 Participants n=107 Participants	100 Participants n=206 Participants

PRIMARY outcome

Timeframe: up to 3 months post transplant

Population: 2 patients in SOC and 1 patient in Experimental groups were excluded in analysis due to patients having primary nonfunction of the graft

The primary endpoint of the study will be the length of time between first dialysis and last dialysis after kidney transplant (duration of DGF).

Outcome measures

Outcome measures
Measure	Standard of Care n=48 Participants Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.	Experimental n=49 Participants Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day.
Number of Days Needed to Recover From Delayed Graft Function (DGF)	14.0 days Interval 7.5 to 21.0	15.0 days Interval 9.0 to 20.0

SECONDARY outcome

Timeframe: up to 3 months post transplant

The secondary endpoint will be number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.

Outcome measures

Outcome measures
Measure	Standard of Care n=48 Participants Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.	Experimental n=49 Participants Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day.
Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF	4.0 dose adjustments Interval 3.0 to 6.0	3.0 dose adjustments Interval 2.0 to 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 3 months post transplant

Number of participants having adverse event will be reported. Adverse events includes the events such as: infections, malignancies, hematological complications including leukopenia, anemia, and thrombocytopenia, cardiovascular complications and events, neuropathy, tremors, gastrointestinal symptoms, uncontrolled hypertension, serious electrolytes abnormalities and immunosuppression-related adverse effects.

Outcome measures

Outcome measures
Measure	Standard of Care n=50 Participants Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.	Experimental n=50 Participants Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day.
Number of Participants Experiencing Related Adverse Events	50 Participants	48 Participants

Adverse Events

Standard of Care

Serious events: 23 serious events

Other events: 50 other events

Deaths: 0 deaths

Experimental

Serious events: 26 serious events

Other events: 50 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Sandesh Parajuli, MD, MBBS

University of Wisconsin Hospital and Clinics

Phone: (608) 265-0152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Standard of Care n=50 participants at risk Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.	Experimental n=50 participants at risk Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day.
Blood and lymphatic system disorders Neutropenia	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Blood and lymphatic system disorders Other	4.0% 2/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	4.0% 2/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Cardiac disorders Atrial Fibrillation	6.0% 3/50 • Number of events 4 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Cardiac disorders Other	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	4.0% 2/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Gastrointestinal disorders Diarrhea	4.0% 2/50 • Number of events 3 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	6.0% 3/50 • Number of events 3 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Gastrointestinal disorders Nausea	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	4.0% 2/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Gastrointestinal disorders Vomiting	4.0% 2/50 • Number of events 3 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	4.0% 2/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Gastrointestinal disorders Other	8.0% 4/50 • Number of events 4 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	6.0% 3/50 • Number of events 3 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
General disorders Edema	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
General disorders Other	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	8.0% 4/50 • Number of events 4 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Hepatobiliary disorders Common bile duct stone	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Infections and infestations C.Difficile	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Infections and infestations COVID-19	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Infections and infestations Surgical Site Infection	4.0% 2/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Infections and infestations Infections and Infestations - Other	10.0% 5/50 • Number of events 6 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	4.0% 2/50 • Number of events 3 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Infections and infestations Urinary tract infection	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Injury, poisoning and procedural complications Incisional dehiscence	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Injury, poisoning and procedural complications Other	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	6.0% 3/50 • Number of events 4 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Metabolism and nutrition disorders Hyperglycemia	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Musculoskeletal and connective tissue disorders Other	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Nervous system disorders Other	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 3 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Surgical and medical procedures fluid collection around kidney transplant	12.0% 6/50 • Number of events 6 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	10.0% 5/50 • Number of events 5 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Renal and urinary disorders Hydronephrosis	2.0% 1/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Renal and urinary disorders Other	4.0% 2/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	8.0% 4/50 • Number of events 4 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.0% 2/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	8.0% 4/50 • Number of events 4 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Respiratory, thoracic and mediastinal disorders Other	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	8.0% 4/50 • Number of events 4 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Vascular disorders Other	4.0% 2/50 • Number of events 3 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Vascular disorders Hematoma	4.0% 2/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	12.0% 6/50 • Number of events 6 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Vascular disorders Hypotension	2.0% 1/50 • Number of events 1 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.
Vascular disorders Hypertension	0.00% 0/50 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.	2.0% 1/50 • Number of events 2 • up to 3 months The occurrence of an Adverse Event or Serious Adverse Event may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor.