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Trial record 6 of 101 for:    Valcyte

A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls

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ClinicalTrials.gov Identifier: NCT01663740
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Masking: None (Open Label);   Primary Purpose: Other
Condition Cytomegalovirus Infections
Intervention Drug: Valganciclovir
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant. Participants with donor negative (D-)/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Period Title: Overall Study
Started 38 [1] 21 [1]
Completed 22 13
Not Completed 16 8
Reason Not Completed
Lost to Follow-up             1             4
Other             9             2
Inclusion/Exclusion not met             1             0
Death             0             1
Withdrawal by Subject             2             1
No end of study status             3             0
[1]
Safety Population
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants Total
Hide Arm/Group Description Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant. Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant. Total of all reporting groups
Overall Number of Baseline Participants 37 21 58
Hide Baseline Analysis Population Description
Safety population included all participants assigned to a cohort. One participant who was considered for inclusion in the study but did not participate, was excluded from baseline analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 21 participants 58 participants
35.6  (7.96) 32.5  (5.81) 34.5  (7.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 21 participants 58 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
37
 100.0%
21
 100.0%
58
 100.0%
Seminal Volume   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliliters (mL)
Number Analyzed 30 participants 20 participants 50 participants
2.4  (1.51) 2.0  (1.37) 2.2  (1.46)
[1]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
Sperm Density   [1] 
Mean (Standard Deviation)
Unit of measure:  Millions of sperm/milliliter (mil/mL)
Number Analyzed 30 participants 20 participants 50 participants
21.0  (28.33) 23.2  (24.90) 21.9  (26.77)
[1]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
Percentage of Normal Sperm Cells   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of normal sperm cells
Number Analyzed 27 participants 18 participants 45 participants
11.4  (18.44) 33.5  (39.03) 20.3  (30.15)
[1]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
Total Motility of Sperm   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent motility
Number Analyzed 30 participants 20 participants 50 participants
25.8  (20.46) 36.3  (24.24) 30.0  (22.42)
[1]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
Terminal Uridine Nick-End Labeling (TUNEL) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 28 participants 18 participants 46 participants
14.4  (9.80) 12.9  (10.60) 13.8  (10.03)
[1]
Measure Description: TUNEL score represents percentage of sperm with fragmented Deoxyribonucleic acid (DNA); total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.
[2]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
Follicle Stimulating Hormone (FSH) Level   [1] 
Mean (Standard Deviation)
Unit of measure:  Units per liter (U/L)
Number Analyzed 29 participants 20 participants 49 participants
10.8  (6.77) 8.6  (6.61) 9.9  (6.72)
[1]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
Luteinizing Hormone (LH) Level   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliunits per milliliter (mU/mL)
Number Analyzed 29 participants 20 participants 49 participants
6.4  (2.61) 6.8  (6.86) 6.6  (4.76)
[1]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
Prolactin Level   [1] 
Mean (Standard Deviation)
Unit of measure:  mU/mL
Number Analyzed 29 participants 20 participants 49 participants
175.4  (73.51) 164.5  (46.22) 170.9  (63.46)
[1]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
Testosterone Level   [1] 
Mean (Standard Deviation)
Unit of measure:  Nanomoles per liter (nmol/L)
Number Analyzed 29 participants 20 participants 49 participants
14.2  (5.83) 11.3  (5.54) 13.0  (5.84)
[1]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
Inhibin B Level   [1] 
Mean (Standard Deviation)
Unit of measure:  Picograms per milliliter (pg/mL)
Number Analyzed 27 participants 19 participants 46 participants
103.4  (55.82) 149.1  (98.45) 122.3  (78.70)
[1]
Measure Analysis Population Description: Number analyzed indicates number of participants evaluated for this analysis.
1.Primary Outcome
Title Change in Sperm Density From Baseline to the End of Treatment (EOT)
Hide Description Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).
Time Frame Baseline, EOT (Week 28)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 24 14
Mean (Standard Error)
Unit of Measure: mil/mL
-9.770  (9.0518) 30.396  (11.3044)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,& duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -40.166
Confidence Interval (2-Sided) 95%
-68.869 to -11.463
Parameter Dispersion
Type: Standard Error of the Mean
Value: 14.1387
Estimation Comments Change in sperm density from Baseline to EOT
2.Secondary Outcome
Title Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)
Hide Description Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at post-baseline visit (EOT and FU) minus the TUNEL score measured at baseline for each participant. A negative change from baseline indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 22 14
Mean (Standard Error)
Unit of Measure: percent score
Change at EOT Number Analyzed 22 participants 14 participants
-3.595  (1.7720) -5.354  (2.0680)
Change at end of FU Number Analyzed 18 participants 10 participants
-4.516  (1.9542) -3.465  (2.5475)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5109
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,& duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 1.758
Confidence Interval (2-Sided) 95%
-3.619 to 7.135
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.6460
Estimation Comments Change in TUNEL score from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7449
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,& duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -1.051
Confidence Interval (2-Sided) 95%
-7.566 to 5.464
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.2058
Estimation Comments Change in TUNEL score from Baseline to end of FU
3.Secondary Outcome
Title Change in TUNEL Score From EOT to End of FU
Hide Description Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at FU minus the TUNEL score measured at EOT for each participant. A negative change from EOT indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0% to 100%, higher score represents more fragmentation.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 16 9
Mean (Standard Error)
Unit of Measure: percent score
4.447  (2.0671) 1.578  (2.5315)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3940
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,& duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 2.869
Confidence Interval (2-Sided) 95%
-4.001 to 9.739
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.2934
Estimation Comments Change in TUNEL score from EOT to end of FU
4.Secondary Outcome
Title Change in Seminal Volume From Baseline to EOT and End of FU
Hide Description Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at post-baseline visit (EOT and FU) - the seminal volume measured at baseline for each participant. A negative change from baseline indicated a lower seminal volume (worsening).
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 25 14
Mean (Standard Error)
Unit of Measure: mL
Change at EOT Number Analyzed 25 participants 14 participants
-0.193  (0.2324) -0.347  (0.2967)
Change at end of FU Number Analyzed 20 participants 10 participants
-0.289  (0.2066) -0.161  (0.2685)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6773
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,& duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 0.155
Confidence Interval (2-Sided) 95%
-0.594 to 0.903
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3687
Estimation Comments Change in seminal volume from Basline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7046
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,& duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.128
Confidence Interval (2-Sided) 95%
-0.806 to 0.551
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3343
Estimation Comments Change in seminal volume from Baseline to end of FU
5.Secondary Outcome
Title Change in Seminal Volume From EOT to End FU
Hide Description Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at FU - the seminal volume measured at EOT for each participant. A negative change from EOT indicated a lower seminal volume (worsening).
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 20 9
Mean (Standard Error)
Unit of Measure: mL
-0.103  (0.2187) 0.024  (0.3067)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7323
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,& duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.128
Confidence Interval (2-Sided) 95%
-0.888 to 0.633
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.3684
Estimation Comments Change in seminal volume from EOT to end of FU
6.Secondary Outcome
Title Change in Sperm Density From EOT to End of FU
Hide Description Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at FU - the sperm density measured at EOT for each participant. A negative change from EOT indicated a lower sperm density (worsening).
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 19 9
Mean (Standard Error)
Unit of Measure: mil/mL
57.149  (17.7736) 5.882  (27.4837)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1756
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,& duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 51.267
Confidence Interval (2-Sided) 95%
-24.626 to 127.159
Parameter Dispersion
Type: Standard Error of the Mean
Value: 36.6869
Estimation Comments Change in sperm density from EOT to end of FU
7.Secondary Outcome
Title Change in Sperm Density From Baseline to End of FU
Hide Description Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (FU) - the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).
Time Frame Baseline, end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 20 10
Mean (Standard Error)
Unit of Measure: mil/mL
39.671  (11.6679) 49.866  (15.8282)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6058
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,& duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -10.195
Confidence Interval (2-Sided) 95%
-49.934 to 29.543
Parameter Dispersion
Type: Standard Error of the Mean
Value: 19.5745
Estimation Comments Change in sperm density from Baseline to end of FU
8.Secondary Outcome
Title Change in Total Motility of Sperm From Baseline to EOT and End of FU
Hide Description Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at post-baseline visit (EOT and FU) - the sperm motility measured at baseline for each participant. A negative change from baseline indicated a lower sperm motility (worsening).
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 24 14
Mean (Standard Error)
Unit of Measure: percent motility
Change at EOT Number Analyzed 24 participants 14 participants
3.839  (5.4259) 25.667  (6.9723)
Change at FU Number Analyzed 20 participants 10 participants
24.736  (4.7920) 34.538  (6.6024)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0222
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -21.828
Confidence Interval (2-Sided) 95%
-40.346 to -3.311
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.1214
Estimation Comments Change in total motility of sperm from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2495
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -9.802
Confidence Interval (2-Sided) 95%
-26.795 to 7.190
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.3702
Estimation Comments Change in total motility of sperm from Baseline to end of FU
9.Secondary Outcome
Title Change in Total Motility of Sperm From EOT to End of FU
Hide Description Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at FU - the sperm motility measured at EOT for each participant. A negative change from EOT indicated a lower sperm motility (worsening).
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 19 9
Mean (Standard Error)
Unit of Measure: percent motility
8.953  (6.3968) 20.635  (9.0663)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3505
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -11.683
Confidence Interval (2-Sided) 95%
-37.039 to 13.674
Parameter Dispersion
Type: Standard Error of the Mean
Value: 12.2576
Estimation Comments Change in total motility of sperm from EOT to end of FU
10.Secondary Outcome
Title Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU
Hide Description Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at post-baseline visit (EOT and FU) - the sperm morphology measured at baseline for each participant. A positive change from baseline indicated an improved sperm morphology.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 21 12
Mean (Standard Error)
Unit of Measure: percentage of normal sperm cells
Change at EOT Number Analyzed 21 participants 12 participants
3.720  (4.0233) 9.461  (5.2737)
Change at end of FU Number Analyzed 19 participants 8 participants
5.128  (2.8907) 6.982  (4.2060)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4021
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -5.741
Confidence Interval (2-Sided) 95%
-19.524 to 8.042
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.7578
Estimation Comments Change in sperm morphology from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7229
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -1.854
Confidence Interval (2-Sided) 95%
-12.423 to 8.714
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.1817
Estimation Comments Change in sperm morphology from Baseline to end of FU
11.Secondary Outcome
Title Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU
Hide Description Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at FU - the sperm morphology measured at EOT for each participant. A positive change from EOT indicated an improved sperm morphology.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 17 7
Mean (Standard Error)
Unit of Measure: percentage of normal sperm cells
-0.714  (4.3420) 2.236  (5.8507)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7080
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -2.950
Confidence Interval (2-Sided) 95%
-19.192 to 13.291
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.7598
Estimation Comments Change in sperm morphology from EOT to end of FU
12.Secondary Outcome
Title Change in Total Testosterone Level From Baseline to EOT and End of FU
Hide Description Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at post-baseline visit (EOT and FU) - the testosterone level measured at baseline for each participant. A negative change from baseline indicated a lower testosterone level.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 26 14
Mean (Standard Error)
Unit of Measure: nmol/L
Change at EOT Number Analyzed 26 participants 14 participants
0.762  (1.0203) 2.623  (1.3586)
Change at end of FU Number Analyzed 19 participants 11 participants
0.395  (1.0260) 1.509  (1.3074)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2673
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -1.861
Confidence Interval (2-Sided) 95%
-5.213 to 1.491
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6512
Estimation Comments Change in total testosterone level from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4949
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -1.114
Confidence Interval (2-Sided) 95%
-4.392 to 2.164
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6147
Estimation Comments Change in total testosterone level from Baseline to end of FU
13.Secondary Outcome
Title Change in Total Testosterone Level From EOT to End of FU
Hide Description Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at FU - the testosterone level measured at EOT for each participant. A negative change from EOT indicated a lower testosterone level.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 19 11
Mean (Standard Error)
Unit of Measure: nmol/L
-0.936  (0.9950) -0.984  (1.2012)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9753
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 0.047
Confidence Interval (2-Sided) 95%
-3.063 to 3.157
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.5100
Estimation Comments Change in total testosterone level from EOT to end of FU
14.Secondary Outcome
Title Change in LH Level From Baseline to EOT and End of FU
Hide Description LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at post-baseline visit (EOT and FU) - the LH level measured at baseline for each participant. A negative change from baseline indicated a lower LH level.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 26 13
Mean (Standard Error)
Unit of Measure: mU/mL
Change at EOT Number Analyzed 26 participants 13 participants
-0.281  (0.3743) -0.357  (0.5190)
Change at end of FU Number Analyzed 20 participants 11 participants
-1.857  (0.2787) -0.642  (0.3635)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9053
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 0.076
Confidence Interval (2-Sided) 95%
-1.214 to 1.366
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.6347
Estimation Comments Change in LH level from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0104
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -1.215
Confidence Interval (2-Sided) 95%
-2.125 to -0.305
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.4477
Estimation Comments Change in LH level from Baseline to end of FU
15.Secondary Outcome
Title Change in LH Level From EOT to End of FU
Hide Description LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at FU - the LH level measured at EOT for each participant. A negative change from EOT indicated a lower LH level.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 20 11
Mean (Standard Error)
Unit of Measure: mU/mL
-1.482  (0.2607) -0.417  (0.3207)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0143
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,& pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -1.065
Confidence Interval (2-Sided) 95%
-1.899 to -0.231
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.4057
Estimation Comments Change in LH level from EOT to end of FU
16.Secondary Outcome
Title Change in FSH Level From Baseline to EOT and End of FU
Hide Description FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at post-baseline visit (EOT and FU) - the FSH level measured at baseline for each participant. A negative change from baseline indicated a lower FSH level.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 26 13
Mean (Standard Error)
Unit of Measure: U/L
Change at EOT Number Analyzed 26 participants 13 participants
1.521  (1.0033) -1.020  (1.4072)
Change at end of FU Number Analyzed 20 participants 11 participants
-2.905  (0.4113) -1.922  (0.5369)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1505
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 2.541
Confidence Interval (2-Sided) 95%
-0.969 to 6.052
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7274
Estimation Comments Change in FSH level from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1539
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.983
Confidence Interval (2-Sided) 95%
-2.352 to 0.387
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.6739
Estimation Comments Change in FSH level from Baseline to end of FU
17.Secondary Outcome
Title Change in FSH Level From EOT to End of FU
Hide Description FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at FU - the FSH level measured at EOT for each participant. A negative change from EOT indicated a lower FSH level.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 20 11
Mean (Standard Error)
Unit of Measure: U/L
-3.462  (0.5036) -1.988  (0.6141)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0798
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -1.474
Confidence Interval (2-Sided) 95%
-3.136 to 0.188
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8084
Estimation Comments Change in FSH level from EOT to end of FU
18.Secondary Outcome
Title Change in Prolactin Level From Baseline to EOT and End of FU
Hide Description Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at post-baseline visit (EOT and FU) - the prolactin level measured at baseline for each participant. A negative change from baseline indicated a lower prolactin level.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 25 13
Mean (Standard Error)
Unit of Measure: mU/mL
Change at EOT Number Analyzed 25 participants 13 participants
15.590  (14.4761) 15.693  (19.2663)
Change at end of FU Number Analyzed 20 participants 11 participants
9.829  (13.1691) -5.443  (16.7203)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9965
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value -0.104
Confidence Interval (2-Sided) 95%
-47.792 to 47.585
Parameter Dispersion
Type: Standard Error of the Mean
Value: 23.4660
Estimation Comments Change in prolactin level from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4636
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 15.272
Confidence Interval (2-Sided) 95%
-26.599 to 57.142
Parameter Dispersion
Type: Standard Error of the Mean
Value: 20.6031
Estimation Comments Change in prolactin level from Baseline to end of FU
19.Secondary Outcome
Title Change in Prolactin Level From EOT to End of FU
Hide Description Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at FU - the prolactin level measured at EOT for each participant. A negative change from EOT indicated a lower prolactin level.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 19 11
Mean (Standard Error)
Unit of Measure: mU/mL
-7.429  (10.9988) -16.169  (13.5322)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6134
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 8.740
Confidence Interval (2-Sided) 95%
-26.438 to 43.917
Parameter Dispersion
Type: Standard Error of the Mean
Value: 17.0805
Estimation Comments Change in prolactin level from EOT to end of FU
20.Secondary Outcome
Title Change in Inhibin B Level From Baseline to EOT and End of FU
Hide Description Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at post-baseline visit (EOT and FU) - the inhibin B level measured at baseline for each participant. A negative change from baseline indicated a lower inhibin B level.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 22 12
Mean (Standard Error)
Unit of Measure: pg/mL
Change at EOT Number Analyzed 22 participants 12 participants
5.075  (7.3778) -3.067  (9.5924)
Change at end of FU Number Analyzed 17 participants 10 participants
51.416  (10.8658) 10.734  (13.9963)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5002
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 8.142
Confidence Interval (2-Sided) 95%
-16.223 to 32.506
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.9301
Estimation Comments Change in inhibin B level from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0279
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 40.682
Confidence Interval (2-Sided) 95%
4.720 to 76.643
Parameter Dispersion
Type: Standard Error of the Mean
Value: 17.6084
Estimation Comments Change in inhibin B level from Baseline to end of FU
21.Secondary Outcome
Title Change in Inhibin B Level From EOT to End of FU
Hide Description Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at FU - the inhibin B level measured at EOT for each participant. A negative change from EOT indicated a lower inhibin B level.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 18 9
Mean (Standard Error)
Unit of Measure: pg/mL
40.329  (13.8221) 14.448  (17.8932)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2548
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables
Method of Estimation Estimation Parameter Mean Difference
Estimated Value 25.881
Confidence Interval (2-Sided) 95%
-20.024 to 71.786
Parameter Dispersion
Type: Standard Error of the Mean
Value: 22.1348
Estimation Comments Change in inhibin B level from EOT to end of FU
22.Secondary Outcome
Title Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU
Hide Description Abnormal sperm density was considered as sperm density less than (<) 20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from baseline to EOT and end of FU was reported.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 24 14
Measure Type: Number
Unit of Measure: percentage of participants
Abnormal to abnormal: EOT Number Analyzed 24 participants 14 participants
50.0 35.7
Abnormal to abnormal: FU Number Analyzed 20 participants 10 participants
25.0 20.0
Normal to abnormal: EOT Number Analyzed 24 participants 14 participants
25.0 7.1
Normal to abnormal: FU Number Analyzed 20 participants 10 participants
0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 14.3
Confidence Interval (2-Sided) 95%
-19.3 to 45.3
Estimation Comments Change in abnormal to abnormal sperm density from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
-34.3 to 43.3
Estimation Comments Change in abnormal to abnormal sperm density from Baseline to end of FU
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 17.9
Confidence Interval (2-Sided) 95%
-15.3 to 48.8
Estimation Comments Change in normal to abnormal sperm density from Baseline to EOT
23.Secondary Outcome
Title Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU
Hide Description Abnormal sperm density was considered as sperm density <20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from EOT to end of FU was reported.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 19 9
Measure Type: Number
Unit of Measure: percentage of participants
Abnormal to abnormal 26.3 22.2
Normal to abnormal 0.0 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-34.5 to 42.5
Estimation Comments Change in abnormal to abnormal sperm density from EOT to end of FU
24.Secondary Outcome
Title Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU
Hide Description Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 22 14
Measure Type: Number
Unit of Measure: percentage of participants
EOT Number Analyzed 22 participants 14 participants
72.7 71.4
FU Number Analyzed 18 participants 10 participants
66.7 60.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-31.3 to 33.7
Estimation Comments Improvement from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
-31.1 to 44.4
Estimation Comments Improvement from Baseline to end of FU
25.Secondary Outcome
Title Percentage of Participants With Improved TUNEL Score From EOT to End of FU
Hide Description Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 16 9
Measure Type: Number
Unit of Measure: percentage of participants
43.8 55.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -11.8
Confidence Interval (2-Sided) 95%
-50.0 to 29.3
Estimation Comments Improvement from EOT to end of FU
26.Secondary Outcome
Title Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU
Hide Description Participants who had higher sperm density compared with the previous visit were considered as improved.
Time Frame Baseline, EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 24 14
Measure Type: Number
Unit of Measure: percentage of participants
EOT Number Analyzed 24 participants 14 participants
33.3 64.3
FU Number Analyzed 20 participants 10 participants
90.0 80.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -31.0
Confidence Interval (2-Sided) 95%
-59.7 to 2.7
Estimation Comments Improvement from Baseline to EOT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 10.0
Confidence Interval (2-Sided) 95%
-29.7 to 47.7
Estimation Comments Improvement from Baseline to end of FU
27.Secondary Outcome
Title Percentage of Participants With Improved Sperm Density From EOT to End of FU
Hide Description Participants who had higher sperm density compared with the previous visit were considered as improved.
Time Frame EOT (Week 28), end of FU (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description:
Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.
Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
Overall Number of Participants Analyzed 19 9
Measure Type: Number
Unit of Measure: percentage of participants
78.9 88.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A: Partcipants Who Received Valganciclovir, Cohort B: Untreated Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -9.9
Confidence Interval (2-Sided) 95%
-47.2 to 27.9
Estimation Comments Improvement from EOT to end of FU
Time Frame Baseline up to end of study (Week 52)
Adverse Event Reporting Description Participants who received at least one dose of valganciclovir in Cohort A and all transplanted participants of Cohort B were included for adverse events analysis.
 
Arm/Group Title Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Hide Arm/Group Description Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant. Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.
All-Cause Mortality
Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   10/31 (32.26%)   12/21 (57.14%) 
Gastrointestinal disorders     
Diarrhea * 1  1/31 (3.23%)  0/21 (0.00%) 
Nausea * 1  1/31 (3.23%)  0/21 (0.00%) 
Rectal hemorrhage * 1  1/31 (3.23%)  0/21 (0.00%) 
Retroperitoneal hematoma * 1  0/31 (0.00%)  1/21 (4.76%) 
General disorders     
Death * 1  0/31 (0.00%)  1/21 (4.76%) 
Pyrexia * 1  1/31 (3.23%)  0/21 (0.00%) 
Immune system disorders     
Transplant rejection * 1  3/31 (9.68%)  1/21 (4.76%) 
Kidney transplant rejection * 1  1/31 (3.23%)  1/21 (4.76%) 
Infections and infestations     
Urinary tract infection * 1  1/31 (3.23%)  1/21 (4.76%) 
Atypical pneumonia * 1  0/31 (0.00%)  1/21 (4.76%) 
Gastroenteritis * 1  0/31 (0.00%)  1/21 (4.76%) 
Pyelonephritis * 1  0/31 (0.00%)  1/21 (4.76%) 
Sinusitis * 1  1/31 (3.23%)  0/21 (0.00%) 
Injury, poisoning and procedural complications     
Foreign body * 1  0/31 (0.00%)  1/21 (4.76%) 
Perinephric collection * 1  0/31 (0.00%)  1/21 (4.76%) 
Investigations     
Blood creatinine increased * 1  0/31 (0.00%)  3/21 (14.29%) 
Pregnancy, puerperium and perinatal conditions     
Fetal death * 1  0/31 (0.00%)  1/21 (4.76%) 
Renal and urinary disorders     
Acute kidney injury * 1  3/31 (9.68%)  1/21 (4.76%) 
Hematuria * 1  1/31 (3.23%)  0/21 (0.00%) 
Renal artery stenosis * 1  0/31 (0.00%)  1/21 (4.76%) 
Tubulointerstitial nephritis * 1  1/31 (3.23%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders     
Diabetic foot * 1  1/31 (3.23%)  0/21 (0.00%) 
Social circumstances     
Treatment noncompliance * 1  1/31 (3.23%)  0/21 (0.00%) 
Vascular disorders     
Hypertension * 1  0/31 (0.00%)  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A: Partcipants Who Received Valganciclovir Cohort B: Untreated Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   24/31 (77.42%)   19/21 (90.48%) 
Blood and lymphatic system disorders     
Anaemia * 1  7/31 (22.58%)  5/21 (23.81%) 
Leukopenia * 1  6/31 (19.35%)  4/21 (19.05%) 
Polycythaemia * 1  2/31 (6.45%)  1/21 (4.76%) 
Cardiac disorders     
Tachycardia * 1  2/31 (6.45%)  0/21 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  5/31 (16.13%)  1/21 (4.76%) 
Diarrhoea * 1  4/31 (12.90%)  2/21 (9.52%) 
Constipation * 1  3/31 (9.68%)  2/21 (9.52%) 
Nausea * 1  4/31 (12.90%)  1/21 (4.76%) 
Vomiting * 1  2/31 (6.45%)  3/21 (14.29%) 
Dyspepsia * 1  2/31 (6.45%)  0/21 (0.00%) 
Gastritis * 1  0/31 (0.00%)  2/21 (9.52%) 
Mouth ulceration * 1  2/31 (6.45%)  0/21 (0.00%) 
Odynophagia * 1  0/31 (0.00%)  2/21 (9.52%) 
General disorders     
Pyrexia * 1  3/31 (9.68%)  4/21 (19.05%) 
Oedema peripheral * 1  5/31 (16.13%)  0/21 (0.00%) 
Fatigue * 1  4/31 (12.90%)  0/21 (0.00%) 
Immune system disorders     
Transplant rejection * 1  3/31 (9.68%)  0/21 (0.00%) 
Infections and infestations     
Upper respiratory tract infection * 1  4/31 (12.90%)  1/21 (4.76%) 
Urinary tract infection * 1  1/31 (3.23%)  3/21 (14.29%) 
Escherichia infection * 1  0/31 (0.00%)  3/21 (14.29%) 
Staphylococcal infection * 1  2/31 (6.45%)  0/21 (0.00%) 
Injury, poisoning and procedural complications     
Incision site pain * 1  4/31 (12.90%)  12/21 (57.14%) 
Procedural pain * 1  2/31 (6.45%)  2/21 (9.52%) 
Incision site haemorrhage * 1  2/31 (6.45%)  0/21 (0.00%) 
Perinephric collection * 1  2/31 (6.45%)  0/21 (0.00%) 
Toxicity to various agents * 1  0/31 (0.00%)  2/21 (9.52%) 
Investigations     
Blood creatinine increased * 1  6/31 (19.35%)  4/21 (19.05%) 
Transaminases increased * 1  5/31 (16.13%)  2/21 (9.52%) 
Immunosuppressant drug level increased * 1  0/31 (0.00%)  4/21 (19.05%) 
Blood pressure increased * 1  3/31 (9.68%)  0/21 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia * 1  8/31 (25.81%)  2/21 (9.52%) 
Hypomagnesaemia * 1  7/31 (22.58%)  0/21 (0.00%) 
Hypophosphataemia * 1  5/31 (16.13%)  1/21 (4.76%) 
Dyslipidaemia * 1  3/31 (9.68%)  1/21 (4.76%) 
Hypercalcaemia * 1  2/31 (6.45%)  0/21 (0.00%) 
Hypervolaemia * 1  2/31 (6.45%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders     
Groin pain * 1  3/31 (9.68%)  1/21 (4.76%) 
Pain in extremity * 1  2/31 (6.45%)  0/21 (0.00%) 
Nervous system disorders     
Tremor * 1  7/31 (22.58%)  5/21 (23.81%) 
Headache * 1  3/31 (9.68%)  4/21 (19.05%) 
Hypoaesthesia * 1  2/31 (6.45%)  1/21 (4.76%) 
Paraesthesia * 1  1/31 (3.23%)  2/21 (9.52%) 
Psychiatric disorders     
Insomnia * 1  3/31 (9.68%)  2/21 (9.52%) 
Renal and urinary disorders     
Haematuria * 1  4/31 (12.90%)  5/21 (23.81%) 
Dysuria * 1  1/31 (3.23%)  4/21 (19.05%) 
Hydronephrosis * 1  3/31 (9.68%)  0/21 (0.00%) 
Proteinuria * 1  1/31 (3.23%)  2/21 (9.52%) 
Reproductive system and breast disorders     
Scrotal swelling * 1  2/31 (6.45%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/31 (3.23%)  3/21 (14.29%) 
Dyspnoea * 1  3/31 (9.68%)  0/21 (0.00%) 
Rhinorrhoea * 1  1/31 (3.23%)  2/21 (9.52%) 
Skin and subcutaneous tissue disorders     
Acne * 1  2/31 (6.45%)  3/21 (14.29%) 
Rash * 1  1/31 (3.23%)  3/21 (14.29%) 
Pruritus * 1  2/31 (6.45%)  1/21 (4.76%) 
Alopecia * 1  2/31 (6.45%)  0/21 (0.00%) 
Surgical and medical procedures     
Wound drainage * 1  0/31 (0.00%)  2/21 (9.52%) 
Vascular disorders     
Hypertension * 1  3/31 (9.68%)  3/21 (14.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01663740     History of Changes
Other Study ID Numbers: WV25651
First Submitted: August 9, 2012
First Posted: August 13, 2012
Results First Submitted: October 2, 2017
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018