Trial Outcomes & Findings for Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients (NCT NCT00772148)
NCT ID: NCT00772148
Last Updated: 2015-06-25
Results Overview
The pharmacokinetic parameters (Cmax and Cmin) were evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
14 days
Results posted on
2015-06-25
Participant Flow
Participant milestones
| Measure |
LCP-Tacro
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Pharmacokinetic Phase (14 Days)
STARTED
|
29
|
29
|
|
Pharmacokinetic Phase (14 Days)
COMPLETED
|
21
|
23
|
|
Pharmacokinetic Phase (14 Days)
NOT COMPLETED
|
8
|
6
|
|
Maintenance Phase (Week 52)
STARTED
|
21
|
23
|
|
Maintenance Phase (Week 52)
COMPLETED
|
17
|
18
|
|
Maintenance Phase (Week 52)
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
LCP-Tacro
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Pharmacokinetic Phase (14 Days)
Adverse Event
|
3
|
1
|
|
Pharmacokinetic Phase (14 Days)
Withdrawal by Subject
|
3
|
5
|
|
Pharmacokinetic Phase (14 Days)
Administrative/other
|
2
|
0
|
|
Maintenance Phase (Week 52)
Death
|
2
|
2
|
|
Maintenance Phase (Week 52)
Adverse Event
|
1
|
0
|
|
Maintenance Phase (Week 52)
Withdrawal by Subject
|
0
|
1
|
|
Maintenance Phase (Week 52)
Administrative/other
|
1
|
2
|
Baseline Characteristics
Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
Baseline characteristics by cohort
| Measure |
LCP-Tacro
n=29 Participants
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
n=29 Participants
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 7.27 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 9.78 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 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
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)
The pharmacokinetic parameters (Cmax and Cmin) were evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.
Outcome measures
| Measure |
LCP-Tacro
n=21 Participants
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
n=23 Participants
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.
Cmax
|
21.30 ng/mL
Standard Deviation 9.93
|
22.95 ng/mL
Standard Deviation 14.57
|
|
Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.
Cmin
|
7.41 ng/mL
Standard Deviation 4.17
|
7.56 ng/mL
Standard Deviation 2.64
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)
The pharmacokinetic parameter (AUC, 0 to 24 hours post dose) was evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.
Outcome measures
| Measure |
LCP-Tacro
n=21 Participants
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
n=23 Participants
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Pharmacokinetics (AUC0-24) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.
|
279.59 ng/mL*hr
Standard Deviation 139.86
|
241.22 ng/mL*hr
Standard Deviation 79.90
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.
Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.
Outcome measures
| Measure |
LCP-Tacro
n=29 Participants
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
n=28 Participants
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.
|
13.79 percentage of patients
|
32.14 percentage of patients
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.
Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.
Outcome measures
| Measure |
LCP-Tacro
n=29 Participants
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
n=28 Participants
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.
|
78.26 percentage of patients
|
75 percentage of patients
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.
Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.
Outcome measures
| Measure |
LCP-Tacro
n=29 Participants
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
n=28 Participants
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.
|
85.71 percentage of patients
|
91.3 percentage of patients
|
SECONDARY outcome
Timeframe: 360 daysNumber of patients who died was compared between the two groups during the study.
Outcome measures
| Measure |
LCP-Tacro
n=29 Participants
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
n=29 Participants
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Number of Participants Who Died Within the 360 Days.
|
2 participants
|
2 participants
|
Adverse Events
LCP-Tacro
Serious events: 17 serious events
Other events: 29 other events
Deaths: 0 deaths
Prograf (Tacrolimus)
Serious events: 10 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LCP-Tacro
n=29 participants at risk
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
n=29 participants at risk
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Cardiac disorders
Cardio-resiratory arrest
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Cardiac disorders
Ventricular dysfunction
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Abdominla pain
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
General disorders
Infusion site extravasation
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
General disorders
Pain
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Hepatobiliary disorders
Cholangitis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Aspargillosis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Cytomegalovirus gastroenteritis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Cytomegalovirus infection
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Gastroenteritis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Hepatitis C
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Peritonitis Bacterial
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Sepsis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Woound infection
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Investigations
Hepatic enzyme increased
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Investigations
Hepatitis C RNA positive
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Investigations
Liver function test abnormal
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hyprglycaemia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bule duct cancer recurrent
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Nervous system disorders
Aphasia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Renal and urinary disorders
Renal Failure Acute
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
Other adverse events
| Measure |
LCP-Tacro
n=29 participants at risk
LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK)
LCP -Tacro: LCP-Tacro tablets will be administered orally once daily in the morning starting at 0.07 - 0.11 mg/kg. The starting dose for African-American patients will be 0.09 - 0.13 mg/kg. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other Names:Tacrolimus modified-release LCP-Tacro™ tablets (0.5 mg, 1 mg, 2 mg, 5 mg)
|
Prograf (Tacrolimus)
n=29 participants at risk
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Prograf: Oral Prograf capsules will be administered starting at 0.10 - 0.15 mg/kg per day in two equally divided morning and evening doses. Subsequent doses of each study drug will be adjusted to maintain target whole blood tacrolimus trough levels of 5 - 20 ng/mL.
Other name: tacrolimus Prograf® capsules (0.5 mg, 1 mg, 5 mg)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.0%
9/29 • Number of events 13 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
31.0%
9/29 • Number of events 9 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Eye disorders
Vission blurred
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.2%
5/29 • Number of events 11 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Ascites
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Constipation
|
34.5%
10/29 • Number of events 10 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
24.1%
7/29 • Number of events 7 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
44.8%
13/29 • Number of events 17 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
37.9%
11/29 • Number of events 11 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Flatulence
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Gastrooesophageal refluc syndrome
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Nausea
|
31.0%
9/29 • Number of events 11 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
44.8%
13/29 • Number of events 13 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
4/29 • Number of events 7 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
17.2%
5/29 • Number of events 7 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
General disorders
Asthenia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
General disorders
Fatigue
|
27.6%
8/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
General disorders
Generalised oedema
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
General disorders
Oedema
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
General disorders
Oedema peripheral
|
37.9%
11/29 • Number of events 14 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
34.5%
10/29 • Number of events 10 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
General disorders
Pain
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
General disorders
Pyrexia
|
17.2%
5/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Hepatobiliary disorders
Cholangitis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Hepatobiliary disorders
Jaundice
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Immune system disorders
Liver transplant rejection
|
24.1%
7/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Hepatitis C
|
31.0%
9/29 • Number of events 9 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
27.6%
8/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Peritonitis bacterial
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Sinusitis
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
13.8%
4/29 • Number of events 6 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Biliary anastomosis complication
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Complications of transplanted liver
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
3.4%
1/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.3%
3/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
27.6%
8/29 • Number of events 9 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
13.8%
4/29 • Number of events 7 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
13.8%
4/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Investigations
Blood creatinine increased
|
17.2%
5/29 • Number of events 7 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Investigations
Blood glucose increased
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Investigations
Hepatic enzyme increased
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Investigations
Liver function test abnormal
|
13.8%
4/29 • Number of events 6 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Investigations
Transaminases incrreased
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Decreased apetite
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Fluid overload
|
24.1%
7/29 • Number of events 7 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
17.2%
5/29 • Number of events 6 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
27.6%
8/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
27.6%
8/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
27.6%
8/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
34.5%
10/29 • Number of events 12 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.7%
6/29 • Number of events 6 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
24.1%
7/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Nervous system disorders
Dizziness
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Nervous system disorders
Headache
|
34.5%
10/29 • Number of events 10 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
37.9%
11/29 • Number of events 12 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
1/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Nervous system disorders
Paraesthesia
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Nervous system disorders
Tremor
|
27.6%
8/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
34.5%
10/29 • Number of events 11 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Psychiatric disorders
Agitation
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Pregnancy, puerperium and perinatal conditions
Anxiety
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Pregnancy, puerperium and perinatal conditions
Confusional state
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Pregnancy, puerperium and perinatal conditions
Depression
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Pregnancy, puerperium and perinatal conditions
Insomnia
|
27.6%
8/29 • Number of events 8 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
20.7%
6/29 • Number of events 6 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Renal and urinary disorders
Proteinurea
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Renal and urinary disorders
Renal failure
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Renal and urinary disorders
Renal failure acure
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
1/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.2%
5/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
10.3%
3/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheesing
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.3%
3/29 • Number of events 5 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Surgical and medical procedures
Post procedural drainage
|
6.9%
2/29 • Number of events 7 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
3.4%
1/29 • Number of events 4 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Vascular disorders
Hypertension
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
24.1%
7/29 • Number of events 7 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/29 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from date of first dose and until 30 days after last dose of study drug. For completing patients the collection time frame was 13 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER