Trial Outcomes & Findings for Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients (NCT NCT02014103)
NCT ID: NCT02014103
Last Updated: 2024-10-15
Results Overview
Report the geometric mean and 95% confidence interval for AUC 0-12hr (ng\*hr/ml) for each formulation in expressor and non expressor transplant recipients
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Expressors
Subjects with at least one \*1 allele of CYP3A5
|
Non-expressors
Subjects homozygous for the \*3 CYP3A5 allele
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
|
Overall Study
Did Receive Allocated Intervention
|
34
|
36
|
|
Overall Study
Discontinued Intervention
|
6
|
5
|
|
Overall Study
Number Subjects Receiving Accord
|
34
|
34
|
|
Overall Study
Number Subjects Receiving Astellas
|
32
|
33
|
|
Overall Study
Number Subjects Receiving Dr. Reddy
|
34
|
33
|
|
Overall Study
Number Subjects Receiving Mylan
|
32
|
34
|
|
Overall Study
Number Subjects Receiving Panacea
|
33
|
33
|
|
Overall Study
Number Subjects Receiving Sandoz
|
34
|
32
|
|
Overall Study
Excluded From Analysis
|
2
|
4
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
Expressors
Subjects with at least one \*1 allele of CYP3A5
|
Non-expressors
Subjects homozygous for the \*3 CYP3A5 allele
|
|---|---|---|
|
Overall Study
Protocol Violation
|
7
|
7
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost venous access
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients
Baseline characteristics by cohort
| Measure |
Expressors
n=26 Participants
Subjects with at least one \*1 allele of CYP3A5
|
Non-expressors
n=27 Participants
Subjects homozygous for the \*3 CYP3A5 allele
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
n=5 Participants
|
57 years
n=7 Participants
|
56.25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
40 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
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.Report the geometric mean and 95% confidence interval for AUC 0-12hr (ng\*hr/ml) for each formulation in expressor and non expressor transplant recipients
Outcome measures
| Measure |
Expressors
n=26 Participants
Subjects with at least one \*1 allele of CYP3A5
|
Non-expressors
n=27 Participants
Subjects homozygous for the \*3 CYP3A5 allele
|
Dr. Reddys
Subjects receiving the Dr Reddy formulation
|
Mylan
Subjects receiving the Mylan formulation
|
Panacea
Subjects receiving the Panacea formulation
|
Sandoz
Subjects receiving the Sandoz formulation
|
|---|---|---|---|---|---|---|
|
Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Accord
|
112.35 ng*hr/ml
Interval 95.83 to 131.72
|
92.37 ng*hr/ml
Interval 81.14 to 105.15
|
—
|
—
|
—
|
—
|
|
Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Astellas
|
97.04 ng*hr/ml
Interval 82.77 to 113.77
|
84.16 ng*hr/ml
Interval 73.93 to 95.81
|
—
|
—
|
—
|
—
|
|
Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Dr. Reddys
|
110.63 ng*hr/ml
Interval 85.83 to 117.98
|
83.96 ng*hr/ml
Interval 73.75 to 95.58
|
—
|
—
|
—
|
—
|
|
Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Mylan
|
96.83 ng*hr/ml
Interval 82.59 to 113.53
|
85.53 ng*hr/ml
Interval 75.13 to 97.37
|
—
|
—
|
—
|
—
|
|
Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Panacea
|
100.58 ng*hr/ml
Interval 85.79 to 117.92
|
89.38 ng*hr/ml
Interval 78.51 to 101.75
|
—
|
—
|
—
|
—
|
|
Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Sandoz
|
98.68 ng*hr/ml
Interval 84.17 to 115.7
|
87.60 ng*hr/ml
Interval 76.95 to 99.73
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.Report the geometric mean and 95% confidence interval for Cmax (ng/ml) for each formulation in expressor and non expressor transplant recipients
Outcome measures
| Measure |
Expressors
n=26 Participants
Subjects with at least one \*1 allele of CYP3A5
|
Non-expressors
n=27 Participants
Subjects homozygous for the \*3 CYP3A5 allele
|
Dr. Reddys
Subjects receiving the Dr Reddy formulation
|
Mylan
Subjects receiving the Mylan formulation
|
Panacea
Subjects receiving the Panacea formulation
|
Sandoz
Subjects receiving the Sandoz formulation
|
|---|---|---|---|---|---|---|
|
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Accord
|
21.72 ng/ml
Interval 17.43 to 27.07
|
15.07 ng/ml
Interval 13.02 to 17.44
|
—
|
—
|
—
|
—
|
|
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Astellas
|
15.31 ng/ml
Interval 12.29 to 19.07
|
13.34 ng/ml
Interval 11.53 to 15.44
|
—
|
—
|
—
|
—
|
|
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Dr. Reddys
|
15.94 ng/ml
Interval 12.79 to 19.86
|
13.58 ng/ml
Interval 11.73 to 15.71
|
—
|
—
|
—
|
—
|
|
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Mylan
|
17.76 ng/ml
Interval 14.26 to 22.13
|
15.15 ng/ml
Interval 13.09 to 17.53
|
—
|
—
|
—
|
—
|
|
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Panacea
|
16.67 ng/ml
Interval 13.38 to 20.78
|
13.23 ng/ml
Interval 11.43 to 15.31
|
—
|
—
|
—
|
—
|
|
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Sandoz
|
14.40 ng/ml
Interval 11.56 to 17.94
|
12.75 ng/ml
Interval 11.02 to 14.76
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at baseline and weekly for 6 weeks at each pharmacokinetic profilePopulation: Participants in the PK population with available data
Conduct safety lab testing specific to transplanted organ function and clinical assessments for adverse events.
Outcome measures
| Measure |
Expressors
n=53 Participants
Subjects with at least one \*1 allele of CYP3A5
|
Non-expressors
n=53 Participants
Subjects homozygous for the \*3 CYP3A5 allele
|
Dr. Reddys
n=53 Participants
Subjects receiving the Dr Reddy formulation
|
Mylan
n=53 Participants
Subjects receiving the Mylan formulation
|
Panacea
n=53 Participants
Subjects receiving the Panacea formulation
|
Sandoz
n=53 Participants
Subjects receiving the Sandoz formulation
|
|---|---|---|---|---|---|---|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
All cause mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Total Other Adverse Events (not including Serious)
|
22 Participants
|
14 Participants
|
20 Participants
|
22 Participants
|
23 Participants
|
13 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Nervous system
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Blood and Lymphatic system
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Cardiac
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Ear and labyrinth
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Metabolism and Nutrition
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Gastrointestinal
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Respiratory, thoracic, and mediastinal
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Musculoskeletal and connective tissue
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Reproductive system and breast disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Infections and infestations
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Skin and subcutaneous tissue
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Psychiatric
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Vascular
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Investigations
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Renal and urinary
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Allergies
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Eye Disorder
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
Endocrine
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Compare the Safety and Efficacy of Each Tacrolimus Formulation in Stable Transplant Subjects
General disorders and administrative site conditions
|
4 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Accord
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Astellas
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Dr. Reddys
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Mylan
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Panacea
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Sandoz
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Accord
n=53 participants at risk
Subjects receiving the Accord formulation
|
Astellas
n=53 participants at risk
Subjects receiving the Astellas formulation
|
Dr. Reddys
n=53 participants at risk
Subjects receiving the Dr Reddy formulation
|
Mylan
n=53 participants at risk
Subjects receiving the Mylan formulation
|
Panacea
n=53 participants at risk
Subjects receiving the Panacea formulation
|
Sandoz
n=53 participants at risk
Subjects receiving the Sandoz formulation
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Anxiety, tremor
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
7.5%
4/53 • Number of events 7 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
7.5%
4/53 • Number of events 4 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Blood and lymphatic system disorders
leukopenia, thrombocytopenia
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Cardiac disorders
hypertension, tachycardia
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Ear and labyrinth disorders
ear erythemia
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Metabolism and nutrition disorders
dehydration, hyperkalemia
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
7.5%
4/53 • Number of events 4 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Gastrointestinal disorders
nausea, vomitting, diarhea
|
7.5%
4/53 • Number of events 4 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Musculoskeletal and connective tissue disorders
muscle aches
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Infections and infestations
respiratory tract infections
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Psychiatric disorders
depression
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Vascular disorders
lost venous access
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Investigations
study related issues
|
7.5%
4/53 • Number of events 4 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Renal and urinary disorders
difficult urinating
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
9.4%
5/53 • Number of events 5 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
General disorders
allergies
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Eye disorders
eye redness, itching
|
3.8%
2/53 • Number of events 2 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
Endocrine disorders
hyperglycemia
|
1.9%
1/53 • Number of events 1 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
0.00%
0/53 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
|
General disorders
administrative issues
|
7.5%
4/53 • Number of events 7 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
5.7%
3/53 • Number of events 3 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
5.7%
3/53 • Number of events 4 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
13.2%
7/53 • Number of events 7 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
5.7%
3/53 • Number of events 3 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
3.8%
2/53 • Number of events 4 • Data was collected during the 6 week period enrolled in the pharmacokinetic study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place