Trial Outcomes & Findings for A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients. (NCT NCT00717314)
NCT ID: NCT00717314
Last Updated: 2014-09-29
Results Overview
The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
87 participants
Primary outcome timeframe
Week 52
Results posted on
2014-09-29
Participant Flow
Participant milestones
| Measure |
Mycophenolate Mofetil (MMF), 50% Calcineurin Inhibitor (CNI)
Participants received MMF capsules, 1.5 to 2.0 grams (g), orally (PO), twice daily (BID) up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50 percent (%) through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
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|---|---|---|
|
Overall Study
STARTED
|
43
|
44
|
|
Overall Study
COMPLETED
|
37
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
| Measure |
Mycophenolate Mofetil (MMF), 50% Calcineurin Inhibitor (CNI)
Participants received MMF capsules, 1.5 to 2.0 grams (g), orally (PO), twice daily (BID) up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50 percent (%) through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
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|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
Baseline characteristics by cohort
| Measure |
MMF, 50% CNI
n=37 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=34 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: PP population
The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.
Outcome measures
| Measure |
MMF, 50% CNI
n=37 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=34 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
|---|---|---|
|
Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%
|
5.4 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: PP population
Graft loss was defined for this protocol as re-transplantion or death.
Outcome measures
| Measure |
MMF, 50% CNI
n=37 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=34 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
|---|---|---|
|
Percentage of Participants With Graft Loss or Death at Week 52
Graft loss
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Graft Loss or Death at Week 52
Death
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 52Population: PP population
BPAR was graded according to Banff criteria.
Outcome measures
| Measure |
MMF, 50% CNI
n=37 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=34 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
|---|---|---|
|
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52
|
0.0 percentage of participants
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 16, 28, and 40Population: PP population; number (n) = number of participants assessed for the specified parameter at a given visit.
Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) \[(140 minus (-) age in years) multiplied by (\*) (weight in kilograms (kg)\] divided by \[72 \* serum creatinine in milligrams per deciliter (mg/dL)\]. For adult females, creatinine clearance in mL/min = 0.85 \* \[(140 - age in years) \* (weight in kg)\] divided by (72 \* serum creatinine in mg/dL).
Outcome measures
| Measure |
MMF, 50% CNI
n=37 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=34 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
|---|---|---|
|
Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])
Baseline (n=36,31)
|
1.385 mL/min
Standard Deviation 3.433
|
2.250 mL/min
Standard Deviation 4.469
|
|
Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])
Change at Week 16 (n=37,33)
|
4.884 mL/min
Standard Deviation 6.016
|
5.629 mL/min
Standard Deviation 8.825
|
|
Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])
Change at Week 28 (n=34,33)
|
5.333 mL/min
Standard Deviation 9.365
|
4.560 mL/min
Standard Deviation 8.325
|
|
Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])
Change at Week 40 (n=35,27)
|
6.131 mL/min
Standard Deviation 9.148
|
4.125 mL/min
Standard Deviation 10.802
|
SECONDARY outcome
Timeframe: Week 52Population: PP population; number (n) = number of participants assessed for the specified parameter at a given visit.
Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = \[(140 - age in years) \* (weight in kg\] divided by \[72 \* serum creatinine in mg/dL\]. For adult females, creatinine clearance in mL/min = 0.85 \* \[(140 - age in years) \* (weight in kg)\] divided by (72 \* serum creatinine in mg/dL).
Outcome measures
| Measure |
MMF, 50% CNI
n=37 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=34 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
|---|---|---|
|
Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52
|
6.551 mL/min
Interval 2.85 to 10.253
|
6.442 mL/min
Interval 2.575 to 10.309
|
SECONDARY outcome
Timeframe: Weeks 16, 28, 40, and 52Population: PP population
Creatinine clearance was calculated using the Cockcroft and Gault formula.
Outcome measures
| Measure |
MMF, 50% CNI
n=37 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=34 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
|---|---|---|
|
Percentage Change in Creatinine Clearance From Baseline
Week 16 (n=37,33)
|
10.38 percentage change from baseline
Standard Deviation 13.97
|
8.72 percentage change from baseline
Standard Deviation 13.45
|
|
Percentage Change in Creatinine Clearance From Baseline
Week 28 (n=34,33)
|
11.45 percentage change from baseline
Standard Deviation 19.87
|
7.51 percentage change from baseline
Standard Deviation 12.53
|
|
Percentage Change in Creatinine Clearance From Baseline
Week 40 (n=35,27)
|
12.37 percentage change from baseline
Standard Deviation 19.14
|
7.03 percentage change from baseline
Standard Deviation 17.86
|
|
Percentage Change in Creatinine Clearance From Baseline
Week 52 (n=37,34)
|
10.17 percentage change from baseline
Standard Deviation 20.63
|
11.51 percentage change from baseline
Standard Deviation 16.20
|
SECONDARY outcome
Timeframe: Week 52Population: PP population
The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization.
Outcome measures
| Measure |
MMF, 50% CNI
n=37 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=34 Participants
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
|---|---|---|
|
Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52
|
8.1 percentage of participants
|
8.8 percentage of participants
|
Adverse Events
MMF, 50% CNI
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
MMF, 75% CNI
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MMF, 50% CNI
n=43 participants at risk
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=40 participants at risk
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
|---|---|---|
|
Infections and infestations
Lung Infection
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Immune system disorders
Acute rejection
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Biliiary tract infection
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Recurrent hepatitis B virus
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Nervous system disorders
Hepatic cancer bladder metastasis
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
Other adverse events
| Measure |
MMF, 50% CNI
n=43 participants at risk
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to 50% through Week 52. The dosage of CNI was reduced to 25% of the dose at entry within the first week, and to 50% of the dose at entry within the first 2 weeks. This 50% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
MMF, 75% CNI
n=40 participants at risk
Participants received MMF capsules, 1.5 to 2.0 g, PO, BID up to Week 52. Participants also received a CNI (at discretion of investigator) at a reduced dosage of up to at least 75% through Week 52. The dosage of CNI was reduced to 50% of the dose at entry within the first 2 weeks, and to at least 75% of the dose at entry within the following 2 weeks. This 75% reduced CNI dose was to be continued through Week 52. Corticosteroids were administered per documented center practice throughout the study with a goal of reducing steroid dose to 0 by 13 weeks post-transplant.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
10.0%
4/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
White blood cell count decreased
|
9.3%
4/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
7.5%
3/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Blood creatinine increased
|
4.7%
2/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
5.0%
2/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Blood urine present
|
4.7%
2/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Blood glucose increased
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Gamma-glutamytransferase increased
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Glucose urine present
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Neutrophil cound decreased
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Red blood cell count decreased
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Weight decreased
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Urine leukocyte esterase positive
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Protein urine present
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
2/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
5.0%
2/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
2/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Gastroenteritis
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Lung infection
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
2/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
4.7%
2/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.7%
2/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Hepatobiliary disorders
Perihepatic discomfort
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
General disorders
Asthenia
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
General disorders
Pyrexia
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Nervous system disorders
Headache
|
2.3%
1/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/43 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
2.5%
1/40 • Adverse events (AEs) were reported at throughout the 52 weeks of the study. Serious AEs (SAEs) were to be reported up to 30 days after stopping the treatment or during the follow-up period; related SAEs should have continued to be reported.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER