Trial Outcomes & Findings for Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation. (NCT NCT01936519)
NCT ID: NCT01936519
Last Updated: 2021-01-29
Results Overview
Renal Function was assessed by 24 hr urine collection creatinine clearance measured (mL/min). 24 Hr urine collection was assessed at baseline, 6 months, 1 year, and 2 years post transplant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
6 months, 1 year, and 2 years
Results posted on
2021-01-29
Participant Flow
Participant milestones
| Measure |
Calcineurin Inhibitor and Mycophenolic Acid
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus and Mycophenolic Acid
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
Baseline characteristics by cohort
| Measure |
Calcineurin Inhibitor and Mycophenolic Acid
n=12 Participants
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus and Mycophenolic Acid
n=12 Participants
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
55.1 years
n=5 Participants
|
56.5 years
n=7 Participants
|
55.79 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Serum Creatinine
|
1.3 mg/dL
n=5 Participants
|
1.23 mg/dL
n=7 Participants
|
1.26 mg/dL
n=5 Participants
|
|
Cockcroft Gault Creatinine Clearance
|
78.11 ml/min
n=5 Participants
|
85.15 ml/min
n=7 Participants
|
81.63 ml/min
n=5 Participants
|
|
Modification of Diet in Renal Disease (MDRD) Clearance
|
61.24 mL/min/1.73 m^2
n=5 Participants
|
69.91 mL/min/1.73 m^2
n=7 Participants
|
65.58 mL/min/1.73 m^2
n=5 Participants
|
|
24 Hour Urine Creatinine Clearance
|
64 mL/min/1.73m2
n=5 Participants
|
59.25 mL/min/1.73m2
n=7 Participants
|
61.63 mL/min/1.73m2
n=5 Participants
|
|
Iothalamate Clearance
|
60.60 ml/min
n=5 Participants
|
58.10 ml/min
n=7 Participants
|
59.35 ml/min
n=5 Participants
|
|
24hr Urine Protein
|
0.2 g/24hrs
n=5 Participants
|
0.19 g/24hrs
n=7 Participants
|
0.1925 g/24hrs
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months, 1 year, and 2 yearsRenal Function was assessed by 24 hr urine collection creatinine clearance measured (mL/min). 24 Hr urine collection was assessed at baseline, 6 months, 1 year, and 2 years post transplant.
Outcome measures
| Measure |
Calcineurin Inhibitor With Mycophenolic Acid
n=11 Participants
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus With Mycophenolic Acid
n=8 Participants
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
|---|---|---|
|
Renal Function as Measured by 24 Hour Urine Creatinine Clearance
24hr Urine Creatinine Clearance at 6 months
|
68.09 mL/min
Standard Deviation 30.08
|
70.75 mL/min
Standard Deviation 29.03
|
|
Renal Function as Measured by 24 Hour Urine Creatinine Clearance
24hr Urine Creatinine Clearance at 1 year
|
68.09 mL/min
Standard Deviation 28.91
|
86.8 mL/min
Standard Deviation 29.34
|
|
Renal Function as Measured by 24 Hour Urine Creatinine Clearance
24hr Urine Creatinine Clearance at 2 years
|
61.54 mL/min
Standard Deviation 27.5
|
90.63 mL/min
Standard Deviation 30.05
|
PRIMARY outcome
Timeframe: 6 months, 1 year, and 2 yearsSerum creatinine levels were assessed at 6 months, 1 year, and 2 years post transplant
Outcome measures
| Measure |
Calcineurin Inhibitor With Mycophenolic Acid
n=11 Participants
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus With Mycophenolic Acid
n=8 Participants
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
|---|---|---|
|
Renal Function as Measured by Serum Creatinine Level
Serum Creatinine at 6 months
|
1.29 mg/dL
Standard Deviation 0.43
|
1.02 mg/dL
Standard Deviation 0.24
|
|
Renal Function as Measured by Serum Creatinine Level
Serum Creatinine at 1 year
|
1.29 mg/dL
Standard Deviation 0.38
|
0.95 mg/dL
Standard Deviation 0.25
|
|
Renal Function as Measured by Serum Creatinine Level
Serum Creatinine at 2 years
|
1.51 mg/dL
Standard Deviation 0.69
|
0.95 mg/dL
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: 6 months, 1 year, and 2 yearsThe Cockcroft-Gault formula for estimating creatinine clearance was determined at 6 months, 1 year, and 2 years post transplant
Outcome measures
| Measure |
Calcineurin Inhibitor With Mycophenolic Acid
n=11 Participants
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus With Mycophenolic Acid
n=8 Participants
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
|---|---|---|
|
Renal Function as Measured by Cockcroft Gault Creatinine Clearance
Cockcroft Gault Creatinine Clearance at 6 months
|
79.84 mL/min/1.73m2
Standard Deviation 29.29
|
100.17 mL/min/1.73m2
Standard Deviation 45.39
|
|
Renal Function as Measured by Cockcroft Gault Creatinine Clearance
Cockcroft Gault Creatinine Clearance at 1 year
|
86.84 mL/min/1.73m2
Standard Deviation 37.17
|
113.47 mL/min/1.73m2
Standard Deviation 60.76
|
|
Renal Function as Measured by Cockcroft Gault Creatinine Clearance
Cockcroft Gault Creatinine Clearance at 2 years
|
80.85 mL/min/1.73m2
Standard Deviation 28.57
|
108.16 mL/min/1.73m2
Standard Deviation 60.1
|
PRIMARY outcome
Timeframe: 6 months, 1 year, and 2 yearsModification of Diet in Renal Disease (MDRD) estimated Glomerular Filtration Rate (eGFR) was assessed at 6 months, 1 year, and 2 years post transplant.
Outcome measures
| Measure |
Calcineurin Inhibitor With Mycophenolic Acid
n=11 Participants
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus With Mycophenolic Acid
n=8 Participants
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
|---|---|---|
|
Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR)
MDRD eGFR at 6 months
|
62.18 mL/min/1.73 m2
Standard Deviation 22.51
|
81.27 mL/min/1.73 m2
Standard Deviation 31.30
|
|
Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR)
MDRD eGFR at 1 year
|
60.63 mL/min/1.73 m2
Standard Deviation 19.68
|
88.01 mL/min/1.73 m2
Standard Deviation 34.08
|
|
Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR)
MDRD eGFR at 2 years
|
53.29 mL/min/1.73 m2
Standard Deviation 17.58
|
87.37 mL/min/1.73 m2
Standard Deviation 32.09
|
PRIMARY outcome
Timeframe: 6 months, 1 year, and 2 yearsIothalamate Clearance was assessed at 6 months, 1 year, and 2 years post transplant.
Outcome measures
| Measure |
Calcineurin Inhibitor With Mycophenolic Acid
n=11 Participants
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus With Mycophenolic Acid
n=8 Participants
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
|---|---|---|
|
Renal Function as Measured by Iothalamate Clearance
Iothalamate Clearance at 6 months
|
67.99 mL/min/1.73m2
Standard Deviation 39.23
|
74.23 mL/min/1.73m2
Standard Deviation 31.30
|
|
Renal Function as Measured by Iothalamate Clearance
Iothalamate Clearance at 1 year
|
66.65 mL/min/1.73m2
Standard Deviation 32.69
|
104.01 mL/min/1.73m2
Standard Deviation 43
|
|
Renal Function as Measured by Iothalamate Clearance
Iothalamate Clearance at 2 years
|
57.19 mL/min/1.73m2
Standard Deviation 24.75
|
79.41 mL/min/1.73m2
Standard Deviation 27.71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsPopulation: SNP source: rs776746 = CYP3A5 gene; rs1045642, rs1128503 and rs2032582 = ABCB1 (MDR1) gene, and rs35599367=Cyp4A4\*22 gene.
A blood sample was obtained from recipients and donors to measure gene polymorphism effects on metabolism of calcineurin inhibitor and everolimus. The polymorphisms are represented as the number of SNP occurrences for the CYP3A5, ABCB1 (MDR1) gene, and CYP4A4\*22 genes.
Outcome measures
| Measure |
Calcineurin Inhibitor With Mycophenolic Acid
n=11 Participants
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus With Mycophenolic Acid
n=11 Participants
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
|---|---|---|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Recipient Genotypes : rs776746 (CYP3A5 gene)
|
11 Participants
|
11 Participants
|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Recipient Genotypes : rs1045642 (ABCB1 gene)
|
6 Participants
|
6 Participants
|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Recipient Genotypes : rs1128503 (ABCB1 gene)
|
7 Participants
|
8 Participants
|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Recipient Genotypes : rs2032582 (ABCB1 gene)
|
1 Participants
|
0 Participants
|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Recipient Genotypes : rs35599367 (CYP4A4*22 gene)
|
1 Participants
|
1 Participants
|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Donor Genotypes : rs776746 (CYP3A5 gene)
|
3 Participants
|
0 Participants
|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Donor Genotypes : rs1045642 (ABCB1 gene)
|
1 Participants
|
5 Participants
|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Donor Genotypes : rs1128503 (ABCB1 gene)
|
0 Participants
|
0 Participants
|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Donor Genotypes : rs2032582 (ABCB1 gene)
|
0 Participants
|
0 Participants
|
|
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
Donor Genotypes : rs35599367 (Cyp4A4*22)
|
0 Participants
|
1 Participants
|
Adverse Events
Calcineurin Inhibitor and Mycophenolic Acid
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Everolimus and Mycophenolic Acid
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Calcineurin Inhibitor and Mycophenolic Acid
n=12 participants at risk
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus and Mycophenolic Acid
n=12 participants at risk
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
|---|---|---|
|
Vascular disorders
Hepatic Artery Thrombosis
|
0.00%
0/12 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Calcineurin Inhibitor and Mycophenolic Acid
n=12 participants at risk
Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
|
Everolimus and Mycophenolic Acid
n=12 participants at risk
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm A: Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
|
|---|---|---|
|
Immune system disorders
Leukopenia
|
58.3%
7/12 • Number of events 7 • 2 years
|
75.0%
9/12 • Number of events 9 • 2 years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
58.3%
7/12 • Number of events 7 • 2 years
|
75.0%
9/12 • Number of events 9 • 2 years
|
|
Immune system disorders
Cellular Rejection
|
8.3%
1/12 • Number of events 1 • 2 years
|
25.0%
3/12 • Number of events 3 • 2 years
|
|
Immune system disorders
antibody mediated rejection
|
8.3%
1/12 • Number of events 1 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Infections and infestations
Cytomegalovirus Infection
|
50.0%
6/12 • Number of events 6 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/12 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Infections and infestations
Minor Infection
|
25.0%
3/12 • Number of events 3 • 2 years
|
41.7%
5/12 • Number of events 5 • 2 years
|
|
Infections and infestations
Dental Infection
|
0.00%
0/12 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Infections and infestations
Clostridium Difficile
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Infections and infestations
Herpes Simplex & Zoster
|
8.3%
1/12 • Number of events 1 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Cardiac disorders
Supraventricular Tachycardia
|
8.3%
1/12 • Number of events 1 • 2 years
|
25.0%
3/12 • Number of events 3 • 2 years
|
|
General disorders
Hypertension
|
33.3%
4/12 • Number of events 4 • 2 years
|
25.0%
3/12 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/12 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Nervous system disorders
Depression
|
8.3%
1/12 • Number of events 1 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Nervous system disorders
Temor
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Nervous system disorders
Insomnia
|
0.00%
0/12 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Nervous system disorders
Mental status changes
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/12 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Anemia
|
8.3%
1/12 • Number of events 1 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Gout
|
8.3%
1/12 • Number of events 1 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
41.7%
5/12 • Number of events 5 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
1/12 • Number of events 1 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • Number of events 1 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
hyperglycemia
|
16.7%
2/12 • Number of events 2 • 2 years
|
0.00%
0/12 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
3/12 • Number of events 3 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Fluid retention
|
8.3%
1/12 • Number of events 1 • 2 years
|
16.7%
2/12 • Number of events 2 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin cancer
|
16.7%
2/12 • Number of events 2 • 2 years
|
0.00%
0/12 • 2 years
|
|
Metabolism and nutrition disorders
Hepatic Steatosis
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Reproductive system and breast disorders
Low Serum Testosterone Level
|
25.0%
3/12 • Number of events 3 • 2 years
|
41.7%
5/12 • Number of events 5 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Emesis
|
16.7%
2/12 • Number of events 2 • 2 years
|
0.00%
0/12 • 2 years
|
|
Gastrointestinal disorders
Upper Gastrointestinal bleed
|
8.3%
1/12 • Number of events 1 • 2 years
|
0.00%
0/12 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • Number of events 3 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/12 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/12 • 2 years
|
8.3%
1/12 • Number of events 1 • 2 years
|
Additional Information
Dr Zakiyah Kadry
Penn State Milton S Hershey Medical Center
Phone: 717 531 5921
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place