Trial Outcomes & Findings for Envarsus XR in African American Renal Transplant Recipients (NCT NCT02956005)
NCT ID: NCT02956005
Last Updated: 2020-03-24
Results Overview
Data not collected - study terminated prematurely when PI left institution.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
1 year
Results posted on
2020-03-24
Participant Flow
Participant milestones
| Measure |
Envarsus
Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL
ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Envarsus
Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL
ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant
|
|---|---|
|
Overall Study
Not eligible
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
12
|
Baseline Characteristics
Envarsus XR in African American Renal Transplant Recipients
Baseline characteristics by cohort
| Measure |
Envarsus
n=18 Participants
Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL
ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Analysis not completed - PI left institution
Data not collected - study terminated prematurely when PI left institution.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: PI left institution - Analysis not completed
Data not collected - study terminated prematurely when PI left institution.
Outcome measures
Outcome data not reported
Adverse Events
Envarsus
Serious events: 10 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Envarsus
n=18 participants at risk
Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL
ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant
|
|---|---|
|
Injury, poisoning and procedural complications
Acute Kidney Injury
|
22.2%
4/18 • Number of events 4 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Acute Hypoxic Respiratory Failure
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Vascular disorders
Hypertension Urgency
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Musculoskeletal and connective tissue disorders
Muscle Tremor
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Psychiatric disorders
Disorientation
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Renal and urinary disorders
Delayed Graft Function
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Infections and infestations
Wound Infection
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver Resection of HCC
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Renal and urinary disorders
Acute Kidney Failure
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Investigations
Elevated Creatinine
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Infections and infestations
Flu
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
Other adverse events
| Measure |
Envarsus
n=18 participants at risk
Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL
ENVARSUS®: ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant
|
|---|---|
|
Vascular disorders
Hypertension
|
38.9%
7/18 • Number of events 7 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Vascular disorders
Worsening Hypertension
|
27.8%
5/18 • Number of events 5 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
6/18 • Number of events 6 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Worsening Anemia
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Renal and urinary disorders
Delayed Graft Function
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Renal and urinary disorders
Slow Graft Function
|
33.3%
6/18 • Number of events 6 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Cardiac disorders
Myocardial Infarction
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Endocrine disorders
Hyperparathyroidism
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Vascular disorders
Coronary Artery Disease
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Endocrine disorders
Diabetes
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Infections and infestations
CMV
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Infections and infestations
BK Viremia
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Renal and urinary disorders
Hematuria
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Cardiac disorders
Chest Pain
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Injury, poisoning and procedural complications
Incisional Pain
|
22.2%
4/18 • Number of events 4 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
General disorders
Weakness/Fatiugue
|
22.2%
4/18 • Number of events 5 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
38.9%
7/18 • Number of events 7 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Pancytopenia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
27.8%
5/18 • Number of events 5 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Endocrine disorders
Secondary Hyperparathyroidism
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Nausea/Emesis
|
33.3%
6/18 • Number of events 6 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Renal and urinary disorders
Urinary Retention
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Reproductive system and breast disorders
Genital Ulcer
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Nervous system disorders
Neurological Symptoms
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
General disorders
Edema
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Acidosis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Injury, poisoning and procedural complications
Seroma
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Investigations
Hypercholesterolemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Hypovolemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Endocrine disorders
Hyperglycemia
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
27.8%
5/18 • Number of events 5 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Ileus
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Immune system disorders
DSA
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Vascular disorders
Elevated intra-operative blood pressure
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Injury, poisoning and procedural complications
Acute Kidney Injury
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Renal and urinary disorders
Frequent Urination
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Renal and urinary disorders
Burning after Urination
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Injury, poisoning and procedural complications
Wound Tear
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Injury, poisoning and procedural complications
Improper Wound Healing
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Investigations
Elevated Creatinine
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Cardiac disorders
Tachycardia
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Injury, poisoning and procedural complications
Transplant Adhesion
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Vascular disorders
Hematoma
|
5.6%
1/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
General disorders
Abdominal Pain
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Hemolytic Syndrome
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Blood and lymphatic system disorders
Chronic Anticoagulation
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Gastrointestinal disorders
GERD
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Infections and infestations
Bacteremia
|
5.6%
1/18 • Number of events 2 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Infections and infestations
HCV
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Lack of appetite
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the time the patient received the first dose until study completion (12 months) or withdrawal, whichever occurred first
No difference from clinicaltrials.gov definition
|
Additional Information
Alexander Gilbert
MedStar Georgetown Transplant Institute
Phone: 202-444-0621
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place