Trial Outcomes & Findings for A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation (NCT NCT00372229)
NCT ID: NCT00372229
Last Updated: 2020-03-11
Results Overview
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
299 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2020-03-11
Participant Flow
342 participants were screened, and 43 participants were not randomized. Central randomization stratified by study center and by induction immunosuppression with polyclonal antibodies, such as such as antithymocyte globuline (ATG), anti-lymphocyte globulin (ALG), or Muromonab-CD3 was performed.
Participant milestones
| Measure |
Valganciclovir Cytomegalovirus (CMV) Prophylaxis
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
Pre-emptive CMV Therapy
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
|---|---|---|
|
Study Phase
STARTED
|
148
|
151
|
|
Study Phase
COMPLETED
|
117
|
122
|
|
Study Phase
NOT COMPLETED
|
31
|
29
|
|
Follow-Up Phase
STARTED
|
117
|
122
|
|
Follow-Up Phase
COMPLETED
|
71
|
70
|
|
Follow-Up Phase
NOT COMPLETED
|
46
|
52
|
Reasons for withdrawal
| Measure |
Valganciclovir Cytomegalovirus (CMV) Prophylaxis
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
Pre-emptive CMV Therapy
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
|---|---|---|
|
Study Phase
Death
|
3
|
2
|
|
Study Phase
Reason not specified
|
3
|
2
|
|
Study Phase
Lost to Follow-up
|
3
|
3
|
|
Follow-Up Phase
Graft loss
|
8
|
7
|
|
Follow-Up Phase
Consent withdrawn
|
13
|
19
|
|
Study Phase
Graft loss
|
0
|
3
|
|
Study Phase
Protocol Violation
|
3
|
4
|
|
Study Phase
Consent withdrawn
|
16
|
14
|
|
Study Phase
Refused treatment/did not cooperate
|
3
|
1
|
|
Follow-Up Phase
Refused treatment/did not cooperate
|
0
|
1
|
|
Follow-Up Phase
Adverse event/intercurrent illness
|
1
|
0
|
|
Follow-Up Phase
Death
|
9
|
12
|
|
Follow-Up Phase
Administrative
|
1
|
0
|
|
Follow-Up Phase
Reason not specified
|
2
|
3
|
|
Follow-Up Phase
Lost to Follow-up
|
12
|
10
|
Baseline Characteristics
A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
Baseline characteristics by cohort
| Measure |
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.18 years
STANDARD_DEVIATION 13.463 • n=5 Participants
|
54.24 years
STANDARD_DEVIATION 11.906 • n=7 Participants
|
52.73 years
STANDARD_DEVIATION 12.771 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months
|
42.6 percentage of participants
Interval 33.9 to 51.3
|
14.1 percentage of participants
Interval 7.0 to 21.1
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced \>50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid \[DNA\] by immunostaining or hybridization, respectively), cerebral spinal fluid \[CSF\]) and/or relevant symptoms or signs of organ dysfunction.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease
|
16.9 percentage of participants
Interval 10.3 to 23.6
|
5.6 percentage of participants
Interval 1.4 to 9.8
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. Urine proteomic pattern was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Urine Proteomic Pattern at Month 12
|
0.1452 units on a scale
Standard Error 0.1006
|
-0.1057 units on a scale
Standard Error 0.1538
|
PRIMARY outcome
Timeframe: Up to 84 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants. Descriptive analysis only.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Graft Loss at Month 84
|
8.61 percentage of participants
|
7.43 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced \>50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With CMV Syndrome Within 12 Months
|
14.6 percentage of participants
Interval 8.7 to 20.6
|
5.6 percentage of participants
Interval 1.6 to 9.7
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
CMV tissue invasive disease was defined as viremia: PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid \[DNA\] by immunostaining or hybridization, respectively), cerebral spinal fluid \[CSF\]) and/or relevant symptoms or signs of organ dysfunction.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months
|
3.6 percentage of participants
Interval 0.5 to 6.8
|
3.3 percentage of participants
Interval 0.1 to 6.4
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Viremia was defined as plasma PCR ≥ 400 copies/ml.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Time to Occurrence of First Viremia Within 12 Months
|
NA days
Interval 160.0 to
Median and upper confidence limit were not reached.
|
NA days
Median and confidence limits were not reached.
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Time-weighted area under the curve (AUC) of the polymerase chain reaction (PCR). Viremia was defined as plasma PCR ≥ 400 copies/ml.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Viral Burden at Viremia
|
3765.8 copies/ml*days
Standard Deviation 8480.521
|
5309.83 copies/ml*days
Standard Deviation 14355.836
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Creatinine clearance was estimated using the Cockcroft-Gault formula.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Creatinine Clearance at Month 12
|
61.3 millilitre(s)/minute
Standard Deviation 22.24
|
61.1 millilitre(s)/minute
Standard Deviation 23.30
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months
|
13.2 percentage of participants
|
18.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Days of Hospitalization
|
32 days
Interval 0.0 to 221.0
|
26.5 days
Interval 0.0 to 258.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Relationship Between Proteomics Pattern and Graft Survival
CMV:Visit 6: With Graft Loss (n=1, 4)
|
-0.300 score on a scale
Standard Deviation 0.7616
|
-0.500 score on a scale
Standard Deviation NA
Only one participant had data.
|
|
Relationship Between Proteomics Pattern and Graft Survival
CMV:Visit 6: Without Graft Loss (n=112, 110)
|
-0.007 score on a scale
Standard Deviation 0.8984
|
0.000 score on a scale
Standard Deviation 0.9535
|
|
Relationship Between Proteomics Pattern and Graft Survival
CMV:Visit 13: Without Graft Loss (n=102, 109)
|
-0.048 score on a scale
Standard Deviation 0.7614
|
0.036 score on a scale
Standard Deviation 0.7976
|
|
Relationship Between Proteomics Pattern and Graft Survival
CMV:Visit 15: With Graft Loss (n=2, 0)
|
—
|
0.100 score on a scale
Standard Deviation 0.7071
|
|
Relationship Between Proteomics Pattern and Graft Survival
CKD273:Visit 6: With Graft Loss (n=1, 4)
|
0.800 score on a scale
Standard Deviation 0.2944
|
0.400 score on a scale
Standard Deviation NA
Only one participant had data.
|
|
Relationship Between Proteomics Pattern and Graft Survival
CKD273:Visit 6: Without Graft Loss (n=112, 110)
|
0.379 score on a scale
Standard Deviation 0.3499
|
0.371 score on a scale
Standard Deviation 0.3578
|
|
Relationship Between Proteomics Pattern and Graft Survival
CKD273:Visit 13: With Graft Loss (n=0, 1)
|
0.500 score on a scale
Standard Deviation NA
Only one participant had data.
|
—
|
|
Relationship Between Proteomics Pattern and Graft Survival
CKD273:Visit 13: Without Graft Loss (n=102, 109)
|
0.293 score on a scale
Standard Deviation 0.3648
|
0.258 score on a scale
Standard Deviation 0.3719
|
|
Relationship Between Proteomics Pattern and Graft Survival
CKD273:Visit 15: With Graft Loss (n=2, 0)
|
—
|
0.600 score on a scale
Standard Deviation 0.5657
|
|
Relationship Between Proteomics Pattern and Graft Survival
CKD273:Visit 15: Without Graft Loss (n=104, 102)
|
0.326 score on a scale
Standard Deviation 0.3618
|
0.270 score on a scale
Standard Deviation 0.3793
|
|
Relationship Between Proteomics Pattern and Graft Survival
CMV:Visit 13: With Graft Loss (n=0, 1)
|
-0.300 score on a scale
Standard Deviation NA
Only one participant had data.
|
—
|
|
Relationship Between Proteomics Pattern and Graft Survival
CMV:Visit 15: Without Graft Loss (n=104, 102)
|
-0.068 score on a scale
Standard Deviation 0.7081
|
-0.076 score on a scale
Standard Deviation 0.6922
|
|
Relationship Between Proteomics Pattern and Graft Survival
Nephropathy:Visit 6: With Graft Loss (n=1, 4)
|
1.100 score on a scale
Standard Deviation 0.9933
|
-0.500 score on a scale
Standard Deviation NA
Only one participant had data.
|
|
Relationship Between Proteomics Pattern and Graft Survival
Nephropathy:Visit 6:Without Graft Loss (n=112,110)
|
0.086 score on a scale
Standard Deviation 1.0489
|
0.107 score on a scale
Standard Deviation 1.1784
|
|
Relationship Between Proteomics Pattern and Graft Survival
Nephropathy:Visit 13: With Graft Loss (n=0, 1)
|
-0.800 score on a scale
Standard Deviation NA
Only one participant had data.
|
—
|
|
Relationship Between Proteomics Pattern and Graft Survival
Nephropathy:Visit 13:Without Graft Loss(n=102,109)
|
0.008 score on a scale
Standard Deviation 1.0848
|
-0.050 score on a scale
Standard Deviation 1.0624
|
|
Relationship Between Proteomics Pattern and Graft Survival
Nephropathy:Visit 15: With Graft Loss (n=2, 0)
|
—
|
1.350 score on a scale
Standard Deviation 2.8991
|
|
Relationship Between Proteomics Pattern and Graft Survival
Nephropathy:Visit15: Without Graft Loss(n=104,102)
|
0.102 score on a scale
Standard Deviation 1.1221
|
-0.007 score on a scale
Standard Deviation 0.8535
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273, CMV, and nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Relationship Between Proteomics Pattern and Participant Survival
Nephropathy:Visit 6: Did not Survive (n=2, 1)
|
-0.100 score on a scale
Standard Deviation NA
Only one participant had data.
|
0.150 score on a scale
Standard Deviation 0.0707
|
|
Relationship Between Proteomics Pattern and Participant Survival
Nephropathy:Visit 6: Survived (n=111, 113)
|
0.124 score on a scale
Standard Deviation 1.0640
|
0.101 score on a scale
Standard Deviation 1.1851
|
|
Relationship Between Proteomics Pattern and Participant Survival
CKD273:Visit 6: Did not Survive (n=2, 1)
|
0.500 score on a scale
Standard Deviation NA
Only one participant had data.
|
0.400 score on a scale
Standard Deviation 0.1414
|
|
Relationship Between Proteomics Pattern and Participant Survival
CKD273:Visit 6: Survived (n=111, 113)
|
0.393 score on a scale
Standard Deviation 0.3570
|
0.371 score on a scale
Standard Deviation 0.3591
|
|
Relationship Between Proteomics Pattern and Participant Survival
CKD273:Visit 13: Did not Survive (n=1, 1)
|
0.500 score on a scale
Standard Deviation NA
Only one participant had data.
|
0.700 score on a scale
Standard Deviation NA
Only one participant had data.
|
|
Relationship Between Proteomics Pattern and Participant Survival
CKD273:Visit 13: Survived (n=101, 109)
|
0.293 score on a scale
Standard Deviation 0.3648
|
0.253 score on a scale
Standard Deviation 0.3711
|
|
Relationship Between Proteomics Pattern and Participant Survival
CKD273:Visit 15: Survived (n=106, 102)
|
0.326 score on a scale
Standard Deviation 0.3618
|
0.276 score on a scale
Standard Deviation 0.3824
|
|
Relationship Between Proteomics Pattern and Participant Survival
CMV:Visit 6: Did not Survive (n=2, 1)
|
-0.900 score on a scale
Standard Deviation NA
Only one participant had data.
|
1.150 score on a scale
Standard Deviation 1.3435
|
|
Relationship Between Proteomics Pattern and Participant Survival
CMV:Visit 6: Survived (n=111, 113)
|
-0.010 score on a scale
Standard Deviation 0.8927
|
-0.025 score on a scale
Standard Deviation 0.9374
|
|
Relationship Between Proteomics Pattern and Participant Survival
CMV:Visit 13: Did not Survive (n=1, 1)
|
-0.300 score on a scale
Standard Deviation NA
Only one participant had data.
|
0.400 score on a scale
Standard Deviation NA
Only one participant had data.
|
|
Relationship Between Proteomics Pattern and Participant Survival
CMV:Visit 13: Survived (n=101, 109)
|
-0.048 score on a scale
Standard Deviation 0.7614
|
0.033 score on a scale
Standard Deviation 0.8008
|
|
Relationship Between Proteomics Pattern and Participant Survival
CMV:Visit 15: Survived (n=106, 102)
|
-0.068 score on a scale
Standard Deviation 0.7081
|
-0.073 score on a scale
Standard Deviation 0.6894
|
|
Relationship Between Proteomics Pattern and Participant Survival
Nephropathy:Visit 13: Did not Survive (n=1, 1)
|
-0.800 score on a scale
Standard Deviation NA
Only one participant had data.
|
1.800 score on a scale
Standard Deviation NA
Only one participant had data.
|
|
Relationship Between Proteomics Pattern and Participant Survival
Nephropathy:Visit 13: Survived (n=101, 109)
|
0.008 score on a scale
Standard Deviation 1.0848
|
-0.068 score on a scale
Standard Deviation 1.0514
|
|
Relationship Between Proteomics Pattern and Participant Survival
Nephropathy:Visit 15: Survived (n=106, 102)
|
0.102 score on a scale
Standard Deviation 1.1221
|
0.019 score on a scale
Standard Deviation 0.9105
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CKD273 was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Proteomics Parameter: CKD273
Visit 6 (n=113, 114)
|
0.394 score on a scale
Standard Deviation 0.3556
|
0.372 score on a scale
Standard Deviation 0.3562
|
|
Proteomics Parameter: CKD273
Visit 13 (n=102, 110)
|
0.295 score on a scale
Standard Deviation 0.3637
|
0.258 score on a scale
Standard Deviation 0.3719
|
|
Proteomics Parameter: CKD273
Visit 15 (n=106, 102)
|
0.326 score on a scale
Standard Deviation 0.3618
|
0.276 score on a scale
Standard Deviation 0.3824
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of CMV was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Proteomics Parameter: CMV
Visit 13 (n=102, 110)
|
-0.05 score on a scale
Standard Deviation 0.7583
|
0.036 score on a scale
Standard Deviation 0.7976
|
|
Proteomics Parameter: CMV
Visit 6 (n=113, 114)
|
-0.018 score on a scale
Standard Deviation 0.8927
|
-0.004 score on a scale
Standard Deviation 0.9504
|
|
Proteomics Parameter: CMV
Visit 15 (n=106, 102)
|
-0.068 score on a scale
Standard Deviation 0.7081
|
-0.073 score on a scale
Standard Deviation 0.6894
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
Proteomics is the complete set of proteins expressed by an organism, tissue, or cell. The proteomics of nephropathy was measured on a scale between -1, indicating no graft alteration, and +1, indicating graft alteration.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Proteomics Parameter: Nephropathy
Visit 6 (n=113, 114)
|
0.122 score on a scale
Standard Deviation 1.0595
|
0.102 score on a scale
Standard Deviation 1.1745
|
|
Proteomics Parameter: Nephropathy
Visit 13 (n=102, 110)
|
0.001 score on a scale
Standard Deviation 1.0826
|
-0.05 score on a scale
Standard Deviation 1.0624
|
|
Proteomics Parameter: Nephropathy
Visit 15 (n=106, 102)
|
0.102 score on a scale
Standard Deviation 1.1221
|
0.019 score on a scale
Standard Deviation 0.9105
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants Surviving at Month 12
|
98.7 percentage of participants
|
98 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Graft Survival at Month 12
|
96.0 percentage of participants
|
98.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Leukopenia: white blood cell (WBC) of \< 3,500/microlitre (μL) and \< 1,000/μL
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Leukopenia Within 12 Months
|
26.5 percentage of participants
|
35.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Neutropenia: absolute neutrophil count (ANC) \< 750/μL within 12 months.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Neutropenia Within 12 Months
|
12.6 percentage of participants
|
16.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Any Opportunistic Infection Within 12 Months
|
37.7 percentage of participants
|
31.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Post-Transplant Diabetes Mellitus
Month 6
|
1.3 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Post-Transplant Diabetes Mellitus
Month 12
|
0.7 percentage of participants
|
3.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis.
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=82 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=17 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment
|
18.3 percentage of participants
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Viremia (active CMV Infection) was defined as PCR ≥ 400 copies/ml.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
84 months
|
60 Participants
|
17 Participants
|
|
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
24 months
|
59 Participants
|
16 Participants
|
|
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
36 months
|
59 Participants
|
16 Participants
|
|
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
48 months
|
59 Participants
|
16 Participants
|
|
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
60 months
|
59 Participants
|
16 Participants
|
|
Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84
72 months
|
60 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced \>50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid \[DNA\] by immunostaining or hybridization, respectively), cerebral spinal fluid \[CSF\]) and/or relevant symptoms or signs of organ dysfunction.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
60 months
|
24 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
24 months
|
23 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
36 months
|
23 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
48 months
|
23 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
72 months
|
24 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84
84 months
|
24 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced \>50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN).
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
24 months
|
20 Participants
|
7 Participants
|
|
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
36 months
|
20 Participants
|
7 Participants
|
|
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
48 months
|
20 Participants
|
7 Participants
|
|
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
60 months
|
21 Participants
|
7 Participants
|
|
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
72 months
|
21 Participants
|
7 Participants
|
|
Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84
84 months
|
21 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid \[DNA\] by immunostaining or hybridization, respectively), cerebral spinal fluid \[CSF\]) and/or relevant symptoms or signs of organ dysfunction.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
36 months
|
5 Participants
|
4 Participants
|
|
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
60 months
|
5 Participants
|
4 Participants
|
|
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
72 months
|
5 Participants
|
4 Participants
|
|
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
24 months
|
5 Participants
|
4 Participants
|
|
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
48 months
|
5 Participants
|
4 Participants
|
|
Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84
84 months
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
24 months
|
59 Participants
|
16 Participants
|
|
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
36 months
|
59 Participants
|
16 Participants
|
|
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
48 months
|
59 Participants
|
16 Participants
|
|
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
60 months
|
59 Participants
|
16 Participants
|
|
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
72 months
|
60 Participants
|
17 Participants
|
|
Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84
84 months
|
60 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
CMV disease comprises the two components of CMV syndrome as well as CMV tissue invasive disease. CMV syndrome was defined as viremia according to plasma PCR ≥ 400 copies/ml and at least one of the following signs: fever of ≥38 °C; new or increased malaise (malaise defined as normal activity reduced \>50%; cannot work or unable to care for self; leukopenia on 2 successive measurements separated by at least 24 hours thrombocytopenia; elevation of hepatic transaminases (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to at least 2 x upper limit of normal (ULN). CMV tissue invasive disease was defined as viremia according plasma PCR ≥ 400 copies/ml and clinical evidence of localized CMV infection (CMV inclusion cells or in situ detection of CMV antigen or deoxyribonucleic acid \[DNA\] by immunostaining or hybridization, respectively), cerebral spinal fluid \[CSF\]) and/or relevant symptoms or signs of organ dysfunction.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
24 months
|
23 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
36 months
|
23 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
48 months
|
23 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
60 months
|
24 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
72 months
|
24 Participants
|
7 Participants
|
|
Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84
84 months
|
24 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
24 months
|
94.70 percentage of participants
|
97.97 percentage of participants
|
|
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
36 months
|
94.04 percentage of participants
|
95.95 percentage of participants
|
|
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
48 months
|
93.38 percentage of participants
|
94.59 percentage of participants
|
|
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
60 months
|
92.05 percentage of participants
|
92.57 percentage of participants
|
|
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
72 months
|
89.40 percentage of participants
|
90.54 percentage of participants
|
|
Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84
84 months
|
88.74 percentage of participants
|
90.54 percentage of participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants Who Died From Months 24 to Month 84
24 months
|
8 Participants
|
3 Participants
|
|
Number of Participants Who Died From Months 24 to Month 84
36 months
|
9 Participants
|
6 Participants
|
|
Number of Participants Who Died From Months 24 to Month 84
48 months
|
10 Participants
|
8 Participants
|
|
Number of Participants Who Died From Months 24 to Month 84
60 months
|
12 Participants
|
11 Participants
|
|
Number of Participants Who Died From Months 24 to Month 84
72 months
|
16 Participants
|
14 Participants
|
|
Number of Participants Who Died From Months 24 to Month 84
84 months
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
24 months
|
94.70 percentage of participants
|
97.30 percentage of participants
|
|
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
36 months
|
93.38 percentage of participants
|
97.30 percentage of participants
|
|
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
48 months
|
93.38 percentage of participants
|
96.62 percentage of participants
|
|
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
60 months
|
92.05 percentage of participants
|
95.95 percentage of participants
|
|
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
72 months
|
91.39 percentage of participants
|
94.59 percentage of participants
|
|
Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84
84 months
|
91.39 percentage of participants
|
92.57 percentage of participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants Who Had Lost Their Transplant up to Month 84
60 months
|
12 Participants
|
6 Participants
|
|
Number of Participants Who Had Lost Their Transplant up to Month 84
72 months
|
13 Participants
|
8 Participants
|
|
Number of Participants Who Had Lost Their Transplant up to Month 84
84 months
|
13 Participants
|
11 Participants
|
|
Number of Participants Who Had Lost Their Transplant up to Month 84
24 months
|
8 Participants
|
4 Participants
|
|
Number of Participants Who Had Lost Their Transplant up to Month 84
36 months
|
10 Participants
|
4 Participants
|
|
Number of Participants Who Had Lost Their Transplant up to Month 84
48 months
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants. Only participants with active CMV infection were included in this analysis; 1 participant in each treatment arm had not developed active CMV infection until Month 72, and thus, they were only included in the number analyzed for results starting from that timepoint.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=60 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=17 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
24 months
|
5 Participants
|
0 Participants
|
|
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
36 months
|
7 Participants
|
0 Participants
|
|
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
48 months
|
7 Participants
|
0 Participants
|
|
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
60 months
|
9 Participants
|
0 Participants
|
|
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
72 months
|
9 Participants
|
0 Participants
|
|
Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84
84 months
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants. Only participants without active CMV infection were included in this analysis; 1 participant in each treatment arm had not developed active CMV infection until Month 72, and thus, they were only included in the number analyzed for results before that timepoint.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=92 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=132 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
24 months
|
3 Participants
|
4 Participants
|
|
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
36 months
|
3 Participants
|
4 Participants
|
|
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
48 months
|
3 Participants
|
5 Participants
|
|
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
60 months
|
3 Participants
|
6 Participants
|
|
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
72 months
|
4 Participants
|
8 Participants
|
|
Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84
84 months
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 84 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants. Only participants in the Valganciclovir CMV Prophylaxis arm (separated based on their active CMV infection status at Month 84) were included in this analysis.
An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=131 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=17 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Valganciclovir CMV Prophylaxis With First Occurrence of Graft Loss at Month 84
|
11.5 percentage of participants
Interval 4.7 to 18.4
|
8.3 percentage of participants
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: Up to 84 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants. Only participants in the Pre-emptive CMV Therapy arm (separated based on their active CMV infection status at Month 84) were included in this analysis.
An analysis for the time to first occurrence of graft loss within month 84 (by means of Kaplan-Meier analysis) was done for all patients who suffered at least once from acute CMV infection (CMV viremia) during this study versus all patients who did not suffer from acute CMV infection (CMV viremia) during the study. Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml).
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=91 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=60 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Kaplan-Meier Estimate of the Percentage of Participants (With Versus Without Active CMV Infection) on Pre-emptive CMV Therapy With First Occurrence of Graft Loss at Month 84
|
5.8 percentage of participants
Interval 0.1 to 11.6
|
17.9 percentage of participants
Interval 7.2 to 28.6
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
24 months
|
15 Participants
|
7 Participants
|
|
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
36 months
|
18 Participants
|
9 Participants
|
|
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
48 months
|
19 Participants
|
12 Participants
|
|
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
60 months
|
23 Participants
|
16 Participants
|
|
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
72 months
|
28 Participants
|
21 Participants
|
|
Number of Participants Who Had Lost Their Transplant or Died up to Month 84
84 months
|
29 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
24 months
|
90.07 percentage of participants
|
95.27 percentage of participants
|
|
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
36 months
|
88.08 percentage of participants
|
93.92 percentage of participants
|
|
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
48 months
|
87.42 percentage of participants
|
91.89 percentage of participants
|
|
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
60 months
|
84.77 percentage of participants
|
89.19 percentage of participants
|
|
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
72 months
|
81.46 percentage of participants
|
85.81 percentage of participants
|
|
Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84
84 months
|
80.79 percentage of participants
|
83.78 percentage of participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
36 months: CMV Positive Donor · No Rejections
|
52 Participants
|
64 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
24 months: CMV Positive Donor · At Least One Rejection
|
27 Participants
|
26 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
24 months: CMV Positive Donor · No Rejections
|
52 Participants
|
65 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
24 months: CMV Negative Donor · At Least One Rejection
|
13 Participants
|
15 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
24 months: CMV Negative Donor · No Rejections
|
59 Participants
|
42 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
36 months: CMV Positive Donor · At Least One Rejection
|
27 Participants
|
27 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
36 months: CMV Negative Donor · At Least One Rejection
|
14 Participants
|
15 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
36 months: CMV Negative Donor · No Rejections
|
58 Participants
|
42 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
48 months: CMV Positive Donor · At Least One Rejection
|
27 Participants
|
27 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
48 months: CMV Positive Donor · No Rejections
|
52 Participants
|
64 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
48 months: CMV Negative Donor · At Least One Rejection
|
14 Participants
|
15 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
48 months: CMV Negative Donor · No Rejections
|
58 Participants
|
42 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
60 months: CMV Positive Donor · At Least One Rejection
|
28 Participants
|
27 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
60 months: CMV Positive Donor · No Rejections
|
51 Participants
|
64 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
60 months: CMV Negative Donor · At Least One Rejection
|
15 Participants
|
15 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
60 months: CMV Negative Donor · No Rejections
|
57 Participants
|
42 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
72 months: CMV Positive Donor · At Least One Rejection
|
28 Participants
|
28 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
72 months: CMV Positive Donor · No Rejections
|
51 Participants
|
63 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
72 months: CMV Negative Donor · At Least One Rejection
|
15 Participants
|
15 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
72 months: CMV Negative Donor · No Rejections
|
57 Participants
|
42 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
84 months: CMV Positive Donor · At Least One Rejection
|
28 Participants
|
28 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
84 months: CMV Positive Donor · No Rejections
|
51 Participants
|
63 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
84 months: CMV Negative Donor · At Least One Rejection
|
15 Participants
|
15 Participants
|
|
Number of Participants With Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
84 months: CMV Negative Donor · No Rejections
|
57 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants. The number analyzed in the table indicates the number of participants with at least one rejection episode at each timepoint.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
24 months: CMV Positive Donor
|
48 graft rejections
|
39 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
24 months: CMV Negative Donor
|
27 graft rejections
|
20 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
36 months: CMV Positive Donor
|
51 graft rejections
|
42 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
36 months: CMV Negative Donor
|
28 graft rejections
|
20 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
48 months: CMV Positive Donor
|
51 graft rejections
|
45 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
48 months: CMV Negative Donor
|
28 graft rejections
|
21 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
60 months: CMV Positive Donor
|
52 graft rejections
|
46 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
60 months: CMV Negative Donor
|
29 graft rejections
|
21 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
72 months: CMV Positive Donor
|
53 graft rejections
|
48 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
72 months: CMV Negative Donor
|
29 graft rejections
|
21 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
84 months: CMV Positive Donor
|
53 graft rejections
|
48 graft rejections
|
|
Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84
84 months: CMV Negative Donor
|
31 graft rejections
|
21 graft rejections
|
SECONDARY outcome
Timeframe: From Month 24 to Month 84Population: The intent-to-treat (ITT) population included all randomized participants.
Creatinine Clearance estimated by Cockcroft-Gault formula.
Outcome measures
| Measure |
Pre-emptive CMV Therapy
n=151 Participants
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
Valganciclovir CMV Prophylaxis
n=148 Participants
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
|---|---|---|
|
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
84 months
|
60.8 millimiters/minute
Standard Deviation 25.39
|
59.5 millimiters/minute
Standard Deviation 26.76
|
|
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
36 months
|
64.5 millimiters/minute
Standard Deviation 25.33
|
63.9 millimiters/minute
Standard Deviation 24.14
|
|
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
48 months
|
62.6 millimiters/minute
Standard Deviation 24.63
|
63.1 millimiters/minute
Standard Deviation 23.81
|
|
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
60 months
|
64.9 millimiters/minute
Standard Deviation 27.85
|
62.2 millimiters/minute
Standard Deviation 22.58
|
|
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
72 months
|
64.7 millimiters/minute
Standard Deviation 27.25
|
63.3 millimiters/minute
Standard Deviation 28.98
|
|
Creatinine Clearance at Month 24 and Every 12 Months up to Month 84
24 months
|
62.9 millimiters/minute
Standard Deviation 25.01
|
63.2 millimiters/minute
Standard Deviation 23.85
|
Adverse Events
Valganciclovir CMV Prophylaxis
Serious events: 94 serious events
Other events: 139 other events
Deaths: 0 deaths
Pre-emptive CMV Therapy
Serious events: 96 serious events
Other events: 140 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valganciclovir CMV Prophylaxis
n=148 participants at risk
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
Pre-emptive CMV Therapy
n=151 participants at risk
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
|---|---|---|
|
Vascular disorders
Arterial occlusive disease
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Arteriovenous fistula
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Deep vein thrombosis
|
2.7%
4/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Haematoma
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Hypertensive crisis
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Lymphocele
|
4.1%
6/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
2.6%
4/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Thrombophlebitis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Venous thrombosis limb
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Surgical and medical procedures
Prostatectomy
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Surgical and medical procedures
Removal of ambulatory peritoneal catheter
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Surgical and medical procedures
Ureteral stent removal
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Surgical and medical procedures
Ureteric operation
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Immune system disorders
Kidney transplant rejection
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Asthenia
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Chest pain
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Death
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Impaired healing
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
2.0%
3/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Malaise
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Oedema peripheral
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Pyrexia
|
2.0%
3/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Psychiatric disorders
Depression
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Psychiatric disorders
Mental disorder
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
2.0%
3/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Shunt blood flow excessive
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
2.0%
3/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Ureteric anastomosis complication
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Urinary anastomotic leak
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Blood calcium increased
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Blood creatinine abnormal
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Blood creatinine increased
|
15.5%
23/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
11.3%
17/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Blood parathyroid hormone increased
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
C-reactive protein increased
|
2.0%
3/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Haemoglobin decreased
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Liver function test abnormal
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Occult blood positive
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Urine output decreased
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Weight decreased
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Angina pectoris
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Cardiac failure
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Cardiac failure acute
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Tachycardia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
2.0%
3/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.4%
5/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Polyneuropathy
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Eye disorders
Charles Bonnet syndrome
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Eye disorders
Endophthalmitis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Eye disorders
Retinal detachment
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Ear and labyrinth disorders
Cupulolithiasis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Colitis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
6/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
3.3%
5/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Duodenitis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Enteritis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Sclerosing encapsulating peritonitis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Haematuria
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Postrenal failure
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Proteinuria
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Renal artery stenosis
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
2.0%
3/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Renal impairment
|
2.0%
3/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Ureteral necrosis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Urinary fistula
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
2.0%
3/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Diabetes with hyperosmolarity
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Abscess oral
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Bronchitis
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Bronchopneumonia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Cystitis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Diverticulitis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Escherichia sepsis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Febrile infection
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Gastrointestinal infection
|
3.4%
5/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Graft infection
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Infected lymphocele
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Influenza
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Localised infection
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Pneumonia
|
4.1%
6/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
4.0%
6/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Pneumonia escherichia
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Postoperative wound infection
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Pyelonephritis
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
1.3%
2/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Sepsis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Septic shock
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.66%
1/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
9/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
8.6%
13/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Urosepsis
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
4.6%
7/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Wound abscess
|
0.68%
1/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
0.00%
0/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
Other adverse events
| Measure |
Valganciclovir CMV Prophylaxis
n=148 participants at risk
Valganciclovir (prophylaxis): 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation.
|
Pre-emptive CMV Therapy
n=151 participants at risk
Valganciclovir (Pre-emptive CMV Therapy): If plasma polymerase chain reaction (PCR) ≥ 400 CMV copies/millilitre, then 1800 mg valganciclovir per day adjusted to renal function for at least 14 days until the second negative PCR (below 400 copies/ml) followed by secondary prophylaxis for 28 days with 900 mg valganciclovir adjusted to renal function.
Ganciclovir: If CMV disease or no response to valganciclovir treatment after 14 days (not falling viral load), then intravenous (IV) ganciclovir or additional appropriate therapy could have been administered according to the local site's standard, instead of valganciclovir.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
20.3%
30/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
24.5%
37/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Vascular disorders
Hypotension
|
4.7%
7/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
6.0%
9/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Fatigue
|
3.4%
5/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
7.3%
11/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Oedema
|
18.2%
27/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
20.5%
31/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Oedema peripheral
|
23.0%
34/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
19.9%
30/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Pain
|
2.7%
4/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
7.3%
11/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
General disorders
Pyrexia
|
8.1%
12/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
6.0%
9/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Psychiatric disorders
Insomnia
|
11.5%
17/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
9.3%
14/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Psychiatric disorders
Sleep disorder
|
6.1%
9/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
8.6%
13/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Blood creatinine increased
|
15.5%
23/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
13.9%
21/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Blood uric acid increased
|
6.8%
10/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
4.6%
7/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
C-reactive protein increased
|
8.8%
13/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
7.3%
11/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.4%
5/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
7.9%
12/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.9%
28/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
25.2%
38/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Investigations
Hepatic enzyme increased
|
9.5%
14/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
4.6%
7/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.7%
7/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
6.0%
9/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
37/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
23.2%
35/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.4%
8/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
6.0%
9/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.5%
23/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
7.9%
12/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.8%
13/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
7.9%
12/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Headache
|
8.1%
12/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
9.3%
14/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Nervous system disorders
Tremor
|
10.8%
16/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
11.3%
17/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
3/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
6.0%
9/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Constipation
|
8.8%
13/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
9.9%
15/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.7%
41/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
27.8%
42/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
5/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
5.3%
8/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Nausea
|
10.8%
16/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
10.6%
16/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
11/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
6.0%
9/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Haematuria
|
5.4%
8/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
5.3%
8/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Leukocyturia
|
3.4%
5/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
9.9%
15/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Renal and urinary disorders
Proteinuria
|
12.2%
18/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
15.2%
23/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
5/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
5.3%
8/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
2/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
6.6%
10/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
8/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
6.0%
9/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
9/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
4.6%
7/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.8%
13/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
3.3%
5/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
8/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
10.6%
16/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.7%
4/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
7.3%
11/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
12.8%
19/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
16.6%
25/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
2.0%
3/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
5.3%
8/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.7%
7/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
11.3%
17/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
11.5%
17/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
10.6%
16/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.1%
15/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
13.2%
20/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
9.5%
14/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
15.2%
23/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
15.5%
23/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
16.6%
25/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.8%
13/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
4.0%
6/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.2%
18/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
11.9%
18/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.1%
12/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
6.0%
9/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
11.5%
17/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
13.9%
21/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Bronchitis
|
4.1%
6/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
5.3%
8/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Nasopharyngitis
|
24.3%
36/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
22.5%
34/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
|
Infections and infestations
Urinary tract infection
|
35.8%
53/148 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
32.5%
49/151 • Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
|
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