Trial Outcomes & Findings for Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant (NCT NCT01666951)
NCT ID: NCT01666951
Last Updated: 2015-07-07
Results Overview
The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
1 days
Results posted on
2015-07-07
Participant Flow
Participant milestones
| Measure |
LCP-Tacro
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
LCP-Tacro
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Overall Study
Not dosed
|
1
|
1
|
Baseline Characteristics
Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant
Baseline characteristics by cohort
| Measure |
LCP-Tacro
n=17 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=17 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
Total
n=34 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
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 13.92 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 11.49 • n=7 Participants
|
49.0 years
STANDARD_DEVIATION 12.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 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
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Outcome measures
| Measure |
LCP-Tacro
n=14 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=12 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
|
382.72 ng*hr/mL
Standard Deviation 233.84
|
147.82 ng*hr/mL
Standard Deviation 85.31
|
PRIMARY outcome
Timeframe: 14 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Outcome measures
| Measure |
LCP-Tacro
n=14 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=12 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
|
371.43 ng*hr/mL
Standard Deviation 133.85
|
244.63 ng*hr/mL
Standard Deviation 66.92
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.
Outcome measures
| Measure |
LCP-Tacro
n=14 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=12 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation
|
357.39 ng*hr/mL
Standard Deviation 146.64
|
205.79 ng*hr/mL
Standard Deviation 36.25
|
PRIMARY outcome
Timeframe: 1 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.
Outcome measures
| Measure |
LCP-Tacro
n=14 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=12 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Cmax
|
32.68 ng/mL
Standard Deviation 20.51
|
12.97 ng/mL
Standard Deviation 7.08
|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
C24
|
13.32 ng/mL
Standard Deviation 8.89
|
5.72 ng/mL
Standard Deviation 5.28
|
PRIMARY outcome
Timeframe: 14 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.
Outcome measures
| Measure |
LCP-Tacro
n=12 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=14 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Cmax
|
30.08 ng/mL
Standard Deviation 14.27
|
18.98 ng/mL
Standard Deviation 6.59
|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
C24
|
9.11 ng/mL
Standard Deviation 2.86
|
7.54 ng/mL
Standard Deviation 2.50
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.
Outcome measures
| Measure |
LCP-Tacro
n=12 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=14 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
Cmax
|
32.51 ng/mL
Standard Deviation 18.74
|
17.38 ng/mL
Standard Deviation 4.07
|
|
Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation
C24
|
9.31 ng/mL
Standard Deviation 3.44
|
6.75 ng/mL
Standard Deviation 2.22
|
PRIMARY outcome
Timeframe: 1 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.
Outcome measures
| Measure |
LCP-Tacro
n=14 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=12 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
|
11.26 hour
Standard Deviation 7.49
|
7.39 hour
Standard Deviation 6.37
|
PRIMARY outcome
Timeframe: 14 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.
Outcome measures
| Measure |
LCP-Tacro
n=14 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=12 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
|
7.03 hour
Standard Deviation 5.69
|
5.03 hour
Standard Deviation 5.81
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.
Outcome measures
| Measure |
LCP-Tacro
n=14 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=12 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation
|
5.69 hour
Standard Deviation 4.11
|
7.69 hour
Standard Deviation 6.87
|
PRIMARY outcome
Timeframe: 14 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.
Outcome measures
| Measure |
LCP-Tacro
n=14 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=12 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
|
126.86 Percentage of fluctuation
Standard Deviation 57.65
|
114.73 Percentage of fluctuation
Standard Deviation 52.36
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.
The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.
Outcome measures
| Measure |
LCP-Tacro
n=14 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=12 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation
|
144.78 Percentage of fluctuation
Standard Deviation 84.63
|
131.4 Percentage of fluctuation
Standard Deviation 75.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 daysPopulation: 18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
Outcome measures
| Measure |
LCP-Tacro
n=8 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=10 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
Daytime SBP
|
140.96 mmHg
Standard Deviation 10,311
|
131.54 mmHg
Standard Deviation 13.835
|
|
Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
Nighttime SBP
|
140.69 mmHg
Standard Deviation 9.147
|
133.38 mmHg
Standard Deviation 17.875
|
|
Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.
Overnight SBP
|
140.80 mmHg
Standard Deviation 10.347
|
132.54 mmHg
Standard Deviation 18.127
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.
Outcome measures
| Measure |
LCP-Tacro
n=8 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=10 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
Daytime SBP
|
139.05 mmHg
Standard Deviation 14.722
|
130.84 mmHg
Standard Deviation 15.754
|
|
Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
Nighttime SBP
|
137.18 mmHg
Standard Deviation 13.283
|
129.09 mmHg
Standard Deviation 16.447
|
|
Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.
Overnight SBP
|
136.11 mmHg
Standard Deviation 13.539
|
127.70 mmHg
Standard Deviation 16.599
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 daysPopulation: 18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.
Outcome measures
| Measure |
LCP-Tacro
n=8 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=10 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
Night:Day ratio SBP
|
0.99 ratio
Standard Deviation 0.035
|
1.01 ratio
Standard Deviation 0.057
|
|
Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.
Overnight:Day Ratio SBP
|
1.00 ratio
Standard Deviation 0.053
|
1.01 ratio
Standard Deviation 0.057
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.
At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.
Outcome measures
| Measure |
LCP-Tacro
n=8 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=10 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
Night:Day ratio SBP
|
0.99 ratio
Standard Deviation 0.035
|
0.98 ratio
Standard Deviation 0.067
|
|
Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.
Overnight:Day Ratio SBP
|
0.99 ratio
Standard Deviation 0.064
|
0.98 ratio
Standard Deviation 0.067
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysThe efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.
Outcome measures
| Measure |
LCP-Tacro
n=18 Participants
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=16 Participants
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
All-cause mortality
|
0 participants
|
0 participants
|
|
Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
Graft Failure
|
0 participants
|
0 participants
|
|
Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
BPAR
|
2 participants
|
0 participants
|
|
Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.
Lost to follow up
|
0 participants
|
0 participants
|
Adverse Events
LCP-Tacro
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Prograf
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCP-Tacro
n=17 participants at risk
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=17 participants at risk
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Cardiac disorders
Atrial Fibrilation
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Immune system disorders
Kidney transplant rejection
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Pelvic Abscess
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Wound infection
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Renal and urinary disorders
Renal INjury
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
Other adverse events
| Measure |
LCP-Tacro
n=17 participants at risk
LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)
LCP-Tacro tablets: Tacrolimus
|
Prograf
n=17 participants at risk
Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)
Prograf: Tacrolimus
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Cardiac disorders
Angina pectoris
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Cardiac disorders
Atrial fibrilation
|
5.9%
1/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Cardiac disorders
Palpitations
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Cardiac disorders
Sinus Tachycardia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Cardiac disorders
Tachycardia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Eye disorders
Uveitis
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Constipation
|
35.3%
6/17 • Number of events 6 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
41.2%
7/17 • Number of events 7 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Flatulence
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
17.6%
3/17 • Number of events 4 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
General disorders
Catheter site realted reaction
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
General disorders
Exercise tolerance decreased
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
General disorders
Fatigue
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
General disorders
Hyperthermia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
General disorders
Oedema
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
General disorders
Oedema peripheral
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Immune system disorders
Kidney transplant rejection
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Oral Candidiasis
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Pelvic abscess
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Vulvovaginal myotic infection
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Infections and infestations
Wound infection
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.9%
1/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Investigations
Blood creatinine increased
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Investigations
Blood pressure increased
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Investigations
Drug level increased
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Investigations
Polyomavirus test positive
|
5.9%
1/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Investigations
Vitamin D decreased
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Investigations
Weight decreased
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Fluid overload
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
17.6%
3/17 • Number of events 4 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Metabolism and nutrition disorders
Vimatin D deficiency
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Nervous system disorders
Paraesthesia
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Nervous system disorders
Tremor
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Psychiatric disorders
Anxiety
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Psychiatric disorders
Insomnia
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Renal and urinary disorders
Haematuria
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Nervous system disorders
Perinephric effusion
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Renal and urinary disorders
Renal injury
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Reproductive system and breast disorders
Penile pain
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Vascular disorders
Flushing
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • Number of events 3 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 2 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
0.00%
0/17 • Adverse events were collected from start of study drug and until 30 days after last dose of study drug for at total of 2 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER