Trial Outcomes & Findings for Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily. (NCT NCT01962922)
NCT ID: NCT01962922
Last Updated: 2018-06-06
Results Overview
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
Day 7
Results posted on
2018-06-06
Participant Flow
25 November 2013 (first patient enrolled) to 09-Mar-2015 (last patient completed initial pharmacokinetics \[PK\] portion of the study, the 'PK Cross-over' period), approximately 16 months enrolled from 3 US medical centers:University of Pennsylvania;University of Illinois at Chicago;Washington School of Medicine
Participant milestones
| Measure |
Sequence 1
•Sequence I: (n=27) Patients will continue on twice-daily IR-Tac capsules on Days 1-7 (24-hour PK profile on Day 7), then patients are switched to Envarsus XR tablets (at a dose 15% lower than their Tac - IR doses) on Day 8. PK on day 14 and 21.
Patients in sequence 1 are on Envarsus XR at Day 21. Patient may continue on extension up to a total of 6 months.
|
Sequence 2
• Sequence II: (n=23) 1 Patients receive Envarsus XR tablets (at 15% lower dose than their IR-Tac dose) on Days 1-7 (24-hour PK profile on Day 7), then patients are switched back to twice-daily Tac - IR treatment beginning on Day 8. PK on days 14 and 21.
Patients in sequence 2 are on Tac - IR at Day 21. Patient have option of continuing in extension portion of the study on Tac - IR for up to 6 months.
|
|---|---|---|
|
PK Portion Day 7
STARTED
|
27
|
23
|
|
PK Portion Day 7
COMPLETED
|
23
|
23
|
|
PK Portion Day 7
NOT COMPLETED
|
4
|
0
|
|
PK Portion Day 14
STARTED
|
23
|
23
|
|
PK Portion Day 14
COMPLETED
|
23
|
23
|
|
PK Portion Day 14
NOT COMPLETED
|
0
|
0
|
|
PK Portion Day 21
STARTED
|
23
|
23
|
|
PK Portion Day 21
COMPLETED
|
23
|
23
|
|
PK Portion Day 21
NOT COMPLETED
|
0
|
0
|
|
Extendion Portion (up to Month 6)
STARTED
|
23
|
23
|
|
Extendion Portion (up to Month 6)
COMPLETED
|
18
|
20
|
|
Extendion Portion (up to Month 6)
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Sequence 1
•Sequence I: (n=27) Patients will continue on twice-daily IR-Tac capsules on Days 1-7 (24-hour PK profile on Day 7), then patients are switched to Envarsus XR tablets (at a dose 15% lower than their Tac - IR doses) on Day 8. PK on day 14 and 21.
Patients in sequence 1 are on Envarsus XR at Day 21. Patient may continue on extension up to a total of 6 months.
|
Sequence 2
• Sequence II: (n=23) 1 Patients receive Envarsus XR tablets (at 15% lower dose than their IR-Tac dose) on Days 1-7 (24-hour PK profile on Day 7), then patients are switched back to twice-daily Tac - IR treatment beginning on Day 8. PK on days 14 and 21.
Patients in sequence 2 are on Tac - IR at Day 21. Patient have option of continuing in extension portion of the study on Tac - IR for up to 6 months.
|
|---|---|---|
|
PK Portion Day 7
Withdrawal by Subject
|
3
|
0
|
|
PK Portion Day 7
non-compliance
|
1
|
0
|
|
Extendion Portion (up to Month 6)
no longer wished to participate in study
|
4
|
3
|
|
Extendion Portion (up to Month 6)
Physician Decision
|
1
|
0
|
Baseline Characteristics
Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.
Baseline characteristics by cohort
| Measure |
Sequence I
n=27 Participants
Sequence I IR-Tac→Envarsus XR (N = 27)
|
Sequence II
n=23 Participants
Sequence II Envarsus XR→IR-Tac (N = 23)
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
23 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: For this outcome measure the PK population N=46 was used.
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Outcome measures
| Measure |
Envarsus XR
n=23 Participants
Tacrolimus tablets once daily.
|
Tacrolimus - IR
n=23 Participants
Tacrolimus capsules twice daily.
|
|---|---|---|
|
Evaluation of AUC(0-24) for Envarsus XR and IR-Tac
|
251.9 ng*hr/mL
Standard Deviation 77.78
|
247.9 ng*hr/mL
Standard Deviation 102.33
|
PRIMARY outcome
Timeframe: Day 7Population: For this outcome measuure the Protocol PK population of N = 46 was used.
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Outcome measures
| Measure |
Envarsus XR
n=23 Participants
Tacrolimus tablets once daily.
|
Tacrolimus - IR
n=23 Participants
Tacrolimus capsules twice daily.
|
|---|---|---|
|
Evaluation of C(Max) for Envarsus XR and IR-Tac
|
16.53 ng/mL
Standard Deviation 5.464
|
26.84 ng/mL
Standard Deviation 13.296
|
PRIMARY outcome
Timeframe: Day 7Population: For this outcome measure the Protocol PK population N= 46 was used.
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Outcome measures
| Measure |
Envarsus XR
n=23 Participants
Tacrolimus tablets once daily.
|
Tacrolimus - IR
n=23 Participants
Tacrolimus capsules twice daily.
|
|---|---|---|
|
Evaluation of C(Min) for Envarsus XR and IR-Tac
|
7.51 ng/mL
Standard Deviation 2.487
|
7.06 ng/mL
Standard Deviation 2.843
|
PRIMARY outcome
Timeframe: Day 14Population: For this outcome measure the PK population N=46 was used
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Outcome measures
| Measure |
Envarsus XR
n=23 Participants
Tacrolimus tablets once daily.
|
Tacrolimus - IR
n=23 Participants
Tacrolimus capsules twice daily.
|
|---|---|---|
|
Evaluation of AUC(0-24) for Envarsus XR and IR-Tac
|
293.3 ng*hr/mL
Standard Deviation 124.40
|
225.7 ng*hr/mL
Standard Deviation 56.27
|
PRIMARY outcome
Timeframe: Day 14Population: For this outcome measuure the Protocol PK population of N = 46 was used.
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Outcome measures
| Measure |
Envarsus XR
n=23 Participants
Tacrolimus tablets once daily.
|
Tacrolimus - IR
n=23 Participants
Tacrolimus capsules twice daily.
|
|---|---|---|
|
Evaluation of C(Max) for Envarsus XR and IR-Tac
|
20.83 ng/mL
Standard Deviation 9.265
|
26.31 ng/mL
Standard Deviation 13.296
|
PRIMARY outcome
Timeframe: Day 14Population: For this outcome measuure the Protocol PK population N= 46 was used.
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours
Outcome measures
| Measure |
Envarsus XR
n=23 Participants
Tacrolimus tablets once daily.
|
Tacrolimus - IR
n=23 Participants
Tacrolimus capsules twice daily.
|
|---|---|---|
|
Evaluation of C(Min) for Envarsus XR and IR-Tac
|
8.34 ng/mL
Standard Deviation 3.769
|
6.46 ng/mL
Standard Deviation 1.692
|
PRIMARY outcome
Timeframe: Day 21Population: For this outcome measure the PK population N=46 was used.
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Outcome measures
| Measure |
Envarsus XR
n=23 Participants
Tacrolimus tablets once daily.
|
Tacrolimus - IR
n=23 Participants
Tacrolimus capsules twice daily.
|
|---|---|---|
|
Evaluation of AUC(0-24) for Envarsus XR and IR-Tac
|
289.3 ng*hr/mL
Standard Deviation 111.79
|
230.3 ng*hr/mL
Standard Deviation 53.83
|
PRIMARY outcome
Timeframe: Day 21Population: For this outcome measuure the Protocol PK population of N = 46 was used.
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Outcome measures
| Measure |
Envarsus XR
n=23 Participants
Tacrolimus tablets once daily.
|
Tacrolimus - IR
n=23 Participants
Tacrolimus capsules twice daily.
|
|---|---|---|
|
Evaluation of C(Max) for Envarsus XR and IR-Tac
|
19.71 ng/mL
Standard Deviation 8.387
|
26.31 ng/mL
Standard Deviation 7.871
|
PRIMARY outcome
Timeframe: Day 21Population: For this outcome measure the Protocol PK population N= 46 was used.
Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.
Outcome measures
| Measure |
Envarsus XR
n=23 Participants
Tacrolimus tablets once daily.
|
Tacrolimus - IR
n=23 Participants
Tacrolimus capsules twice daily.
|
|---|---|---|
|
Evaluation of C(Min) for Envarsus XR and IR-Tac
|
8.01 ng/mL
Standard Deviation 3.281
|
6.62 ng/mL
Standard Deviation 1.692
|
Adverse Events
Envarsus XR
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Tacrolimus - IR
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Envarsus XR
n=50 participants at risk
Tacrolimus extended release
|
Tacrolimus - IR
n=50 participants at risk
brand IR tacrolimus
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Infections and infestations
Otitis Media
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Renal and urinary disorders
Acute renal failure
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
Other adverse events
| Measure |
Envarsus XR
n=50 participants at risk
Tacrolimus extended release
|
Tacrolimus - IR
n=50 participants at risk
brand IR tacrolimus
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
10.0%
5/50 • Number of events 5 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Investigations
Blood creatinine increased
|
14.0%
7/50 • Number of events 8 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
8.0%
4/50 • Number of events 4 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Investigations
Glomerular filtration rate decreased
|
10.0%
5/50 • Number of events 5 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
2.0%
1/50 • Number of events 1 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/50 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
6.0%
3/50 • Number of events 3 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • Number of events 3 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
10.0%
5/50 • Number of events 7 • Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.
Adverse events are associated with the treatment the patient is on at the onset date of the adverse event and not the portion of the study (e.g. PK or extention portion). The below figures are cumulative for the entire study participation start of study through 6 month extension.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has no objection to publication of the results of the Study by Site based on information collected or generated by Site; provided, however, that such publication must not precede the primary manuscript (unless no such multi-site publication is completed within twelve (12) months following the completion of the Study or unless Sponsor notifies Site in writing that no such multi- center publication shall be made).
- Publication restrictions are in place
Restriction type: OTHER