Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This 2 arm study will compare the efficacy of 100 days of Valcyte (900mg po daily) prophylaxis with that of no prophylaxis, under the condition of pre-emptive therapy of active CMV infection, in CMV positive renal transplant recipients. The influence of the two prevention concepts on the occurrence of direct and indirect effects of active CMV infections will be compared. The anticipated time on study treatment is 3 months-1 year, and the target sample size is 100-500 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valganciclovir Cytomegalovirus (CMV) Prophylaxis | Experimental |
| |
| Pre-emptive CMV Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valganciclovir CMV Prophylaxis | Drug | 900 mg valganciclovir, taken orally once daily, adjusted to renal function starting within 14 days of transplantation until Day 100 after transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months | Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml). | Up to 12 months |
| Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease | 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. | Up to 12 months |
| Urine Proteomic Pattern at Month 12 | 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. | Up to 12 months |
| Percentage of Participants With Graft Loss at Month 84 | Up to 84 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CMV Syndrome Within 12 Months | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | 6020 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39807668 | Derived | Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4. | |
| 38700045 | Derived |
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Pre-emptive CMV Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Valganciclovir (Pre-emptive CMV Therapy) | Drug | 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. 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. |
|
|
| Ganciclovir | Drug | 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. |
|
| Up to 12 months |
| Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months | 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. | Up to 12 months |
| Time to Occurrence of First Viremia Within 12 Months | Viremia was defined as plasma PCR ≥ 400 copies/ml. | Up to 12 months |
| Viral Burden at Viremia | Time-weighted area under the curve (AUC) of the polymerase chain reaction (PCR). Viremia was defined as plasma PCR ≥ 400 copies/ml. | Up to 12 months |
| Creatinine Clearance at Month 12 | Creatinine clearance was estimated using the Cockcroft-Gault formula. | Up to 12 months |
| Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months | Up to 12 months |
| Days of Hospitalization | Up to 12 months |
| Relationship Between Proteomics Pattern and Graft Survival | 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. | Up to 12 months |
| Relationship Between Proteomics Pattern and Participant Survival | 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. | Up to 12 months |
| Proteomics Parameter: CKD273 | 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. | Up to 12 months |
| Proteomics Parameter: CMV | 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. | Up to 12 months |
| Proteomics Parameter: Nephropathy | 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. | Up to 12 months |
| Percentage of Participants Surviving at Month 12 | Up to 12 months |
| Percentage of Participants With Graft Survival at Month 12 | Up to 12 months |
| Percentage of Participants With Leukopenia Within 12 Months | Leukopenia: white blood cell (WBC) of < 3,500/microlitre (μL) and < 1,000/μL | Up to 12 months |
| Percentage of Participants With Neutropenia Within 12 Months | Neutropenia: absolute neutrophil count (ANC) < 750/μL within 12 months. | Up to 12 months |
| Percentage of Participants With Any Opportunistic Infection Within 12 Months | Up to 12 months |
| Percentage of Participants With Post-Transplant Diabetes Mellitus | Up to 12 months |
| Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment | Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml). | Up to 12 months |
| Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | Viremia (active CMV Infection) was defined as PCR ≥ 400 copies/ml. | From Month 24 to Month 84 |
| Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 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. | From Month 24 to Month 84 |
| Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 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). | From Month 24 to Month 84 |
| Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 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. | From Month 24 to Month 84 |
| Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml). | From Month 24 to Month 84 |
| Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 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. | From Month 24 to Month 84 |
| Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | From Month 24 to Month 84 |
| Number of Participants Who Died From Months 24 to Month 84 | From Month 24 to Month 84 |
| Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | From Month 24 to Month 84 |
| Number of Participants Who Had Lost Their Transplant up to Month 84 | From Month 24 to Month 84 |
| Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | From Month 24 to Month 84 |
| Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | From Month 24 to Month 84 |
| 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 | 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). | Up to 84 months |
| 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 | 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). | Up to 84 months |
| Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | From Month 24 to Month 84 |
| Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | From Month 24 to Month 84 |
| 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 | From Month 24 to Month 84 |
| Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | From Month 24 to Month 84 |
| Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | Creatinine Clearance estimated by Cockcroft-Gault formula. | From Month 24 to Month 84 |
| Vienna |
| 1090 |
| Austria |
| Aachen | 52057 | Germany |
| Berlin | 12203 | Germany |
| Berlin | 13353 | Germany |
| Bremen | 28205 | Germany |
| Cologne | 50937 | Germany |
| Düsseldorf | 40225 | Germany |
| Erlangen | 91054 | Germany |
| Essen | 45122 | Germany |
| Frankfurt | 60596 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Hamburg | 20246 | Germany |
| Hannoversch Münden | 34346 | Germany |
| Hanover | 30625 | Germany |
| Jena | 07747 | Germany |
| Leipzig | 04103 | Germany |
| Lübeck | 23562 | Germany |
| München | 81377 | Germany |
| München | 81675 | Germany |
| Münster | 48149 | Germany |
| Regensburg | 93053 | Germany |
| Tübingen | 72076 | Germany |
| Würzburg | 97080 | Germany |
| Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5. |
| 33861738 | Derived | Mazzola P, Schaeffeler E, Witzke O, Nitschke M, Kliem V, Zortel M, Wagner EM, Schwab M, Hauser IA. No association of genetic variants in TLR4, TNF-alpha, IL10, IFN-gamma, and IL37 in cytomegalovirus-positive renal allograft recipients with active CMV infection-Subanalysis of the prospective randomised VIPP study. PLoS One. 2021 Apr 16;16(4):e0246118. doi: 10.1371/journal.pone.0246118. eCollection 2021. |
| 29166336 | Derived | Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V. Valganciclovir Prophylaxis Versus Preemptive Therapy in Cytomegalovirus-Positive Renal Allograft Recipients: Long-term Results After 7 Years of a Randomized Clinical Trial. Transplantation. 2018 May;102(5):876-882. doi: 10.1097/TP.0000000000002024. |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-Up Phase |
|
|
The safety population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Valganciclovir 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Active Cytomegalovirus (CMV) Infection Within 12 Months | Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml). | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | 96% Confidence Interval | percentage of participants | Up to 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With CMV Disease Within 12 Months Including CMV Syndrome and Tissue Invasive Disease | 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. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | 96% Confidence Interval | percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Urine Proteomic Pattern at Month 12 | 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. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Least Squares Mean | Standard Error | units on a scale | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Graft Loss at Month 84 | The intent-to-treat (ITT) population included all randomized participants. Descriptive analysis only. | Posted | Number | percentage of participants | Up to 84 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CMV Syndrome Within 12 Months | 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). | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CMV Tissue Invasive Disease Within 12 Months | 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. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Occurrence of First Viremia Within 12 Months | Viremia was defined as plasma PCR ≥ 400 copies/ml. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Median | 95% Confidence Interval | days | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Viral Burden at Viremia | Time-weighted area under the curve (AUC) of the polymerase chain reaction (PCR). Viremia was defined as plasma PCR ≥ 400 copies/ml. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Mean | Standard Deviation | copies/ml*days | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Creatinine Clearance at Month 12 | Creatinine clearance was estimated using the Cockcroft-Gault formula. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Mean | Standard Deviation | millilitre(s)/minute | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least One Treated and Biopsy-Proven Acute Rejection Episode Within 12 Months | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Days of Hospitalization | The intent-to-treat (ITT) population included all randomized participants. | Posted | Median | Full Range | days | Up to 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Relationship Between Proteomics Pattern and Graft Survival | 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. | The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Relationship Between Proteomics Pattern and Participant Survival | 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. | The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proteomics Parameter: CKD273 | 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. | The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proteomics Parameter: CMV | 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. | The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proteomics Parameter: Nephropathy | 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. | The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Up to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Surviving at Month 12 | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Graft Survival at Month 12 | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Leukopenia Within 12 Months | Leukopenia: white blood cell (WBC) of < 3,500/microlitre (μL) and < 1,000/μL | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Neutropenia Within 12 Months | Neutropenia: absolute neutrophil count (ANC) < 750/μL within 12 months. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Any Opportunistic Infection Within 12 Months | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Post-Transplant Diabetes Mellitus | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | Up to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Active CMV Infections Not Responding to Valganciclovir or IV Ganciclovir Treatment | Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml). | The intent-to-treat (ITT) population included all randomized participants. Only participants with data were included in the analysis. | Posted | Number | percentage of participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With CMV Viremia (Active CMV Infection) From Baseline to Month 24 and Every 12 Months up to Month 84 | Viremia (active CMV Infection) was defined as PCR ≥ 400 copies/ml. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With CMV Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 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. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With CMV Syndrome From Baseline to Month 24 and Every 12 Months up to Month 84 | 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). | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With CMV Tissue Invasive Disease From Baseline to Month 24 and Every 12 Months up to Month 84 | 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. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Active CMV Infection After Month 24 and Every 12 Months up to Month 84 | Active CMV infection was defined as plasma polymerase chain reaction (PCR) ≥ 400 copies/millilitre (ml). | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With CMV Disease After Month 24 and Every 12 Months up to Month 84 | 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. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Surviving at Month 24 and Every 12 Months up to Month 84 | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | From Month 24 to Month 84 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died From Months 24 to Month 84 | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Graft Survival at Month 24 and Every 12 Months up to Month 84 | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | From Month 24 to Month 84 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Had Lost Their Transplant up to Month 84 | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 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. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Without Active CMV Infection Who Had Lost Their Transplant up to Month 84 | 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. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 84 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 84 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Had Lost Their Transplant or Died up to Month 84 | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Graft Survival or Participant Survival at Month 24 and Every 12 Months up to Month 84 | The intent-to-treat (ITT) population included all randomized participants. | Posted | Number | percentage of participants | From Month 24 to Month 84 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | The intent-to-treat (ITT) population included all randomized participants. | Posted | Count of Participants | Participants | From Month 24 to Month 84 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Graft Rejections by CMV Status (Positive or Negative) of the Donor at Month 24 and Every 12 Months up to Month 84 | 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. | Posted | Number | graft rejections | From Month 24 to Month 84 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Creatinine Clearance at Month 24 and Every 12 Months up to Month 84 | Creatinine Clearance estimated by Cockcroft-Gault formula. | The intent-to-treat (ITT) population included all randomized participants. | Posted | Mean | Standard Deviation | millimiters/minute | From Month 24 to Month 84 |
|
|
Up to 7 years
Analysis was performed on the safety analysis population. The safety population included all randomized participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Valganciclovir 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. | 94 | 148 | 139 | 148 | ||
| EG001 | 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. | 96 | 151 | 140 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial occlusive disease | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Prostatectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Removal of ambulatory peritoneal catheter | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Ureteral stent removal | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Ureteric operation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Angiosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Graft complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Perirenal haematoma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Shunt blood flow excessive | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Transplant failure | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Ureteric anastomosis complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary anastomotic leak | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood creatinine abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood parathyroid hormone increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Trifascicular block | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Congenital cystic kidney disease | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea at rest | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Benign intracranial hypertension | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Charles Bonnet syndrome | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Endophthalmitis | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cupulolithiasis | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diverticulitis intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sclerosing encapsulating peritonitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Postrenal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ureteral necrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary fistula | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetes with hyperosmolarity | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Graft infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia escherichia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Wound abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077562 | Valganciclovir |
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Refused treatment/did not cooperate |
|
| Adverse event/intercurrent illness |
|
| Death |
|
| Administrative |
|
| Reason not specified |
|
| Lost to Follow-up |
|
| Male |
|
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.
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| 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.
|
|
|
|
|
|
| Units | Counts |
|---|
| 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.
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| OG001 | Pre-emptive CMV Therapy, No CMV Infection at Month 84 | Participants with active CMV infection at Month 84 received valganciclovir 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 (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). |
|
|
|
|
|
| Participants |
|
|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| No Rejections |
|
| No Rejections |
|
| No Rejections |
|
| No Rejections |
|
| No Rejections |
|
| No Rejections |
|
| No Rejections |
|
| No Rejections |
|
| No Rejections |
|
| No Rejections |
|
| No Rejections |
|