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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022514-47 | EudraCT Number |
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This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valganciclovir | Experimental | Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in milligrams) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valganciclovir [Valcyte] | Drug | Oral, daily for up to 200 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator | A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Pediatric Nephrology | Gainesville | Florida | United States | |||
| UCLA Center For Health Sciences; Division of Pediatric Nephrology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valganciclovir | Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose [in milligrams (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance]. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator | A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever ≥ 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis ≥ 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction. | 52 weeks |
| Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant | Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories < 150 CP/mL and above. | 52 weeks |
| Number of Participants With Biopsy Proven Rejection | Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997. | 52 Weeks |
| Number of Participants With Graft Loss | Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation. | 52 Weeks |
| Number of Participants With Death | 52 Weeks |
| Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes) | All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir. | 52 Weeks |
| Los Angeles |
| Louisiana |
| 90095-1752 |
| United States |
| Mount Sinai Medical Center | New York | New York | 10029-6574 | United States |
| Uni of Utah Health Science Center; Pediatric Nephrology | Salt Lake City | Utah | 84108 | United States |
| Children'S Hospital At Westmead; Department of Nephrology | Westmead | New South Wales | 2145 | Australia |
| Mater Childrens Hospital | South Brisbane, Herston | Queensland | 4029 | Australia |
| Royal Children'S Hospital; Department of Nephrology | Parkville | Victoria | 3052 | Australia |
| Universidade Federal de Sao Paulo - UNIFESP | São Paulo | São Paulo | 04038-002 | Brazil |
| CHU de Nantes - Service de pédiatrie | Nantes | 44093 | France |
| Hôpital Robert Debré; Nephrologie pediatrique | Paris | 75019 | France |
| Hop Necker Enfants Malades;Nephrologie Pediatrique | Paris | 75743 | France |
| Klinik und Poliklinik für Kinder- und Jugendmedizin- Köln, Uniklinik Köln | Cologne | 50937 | Germany |
| Universitätsklinikum für Kinder und Jugendmedizin Hamburg | Hamburg | 20246 | Germany |
| KfH Nierenzentrum für Kinder und Jugendliche an der MHH Hannover | Hanover | 30625 | Germany |
| Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg | Heidelberg | 69120 | Germany |
| Centenario Hospital Miguel Hidalgo | Aguascalientes | 20230 | Mexico |
| Instituto Mexicano de Transplantes | Cuernavaca | 62428 | Mexico |
| Hospital Infantil de Mexico Federico Gomez | México | 06720 | Mexico |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz: Nefrologia Pediatrica | Madrid | 28046 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica | Seville | 41013 | Spain |
| Sahlgrenska Sjukhuset; Transplantationskirurgiska Kliniken | Gothenburg | 41345 | Sweden |
| Birmingham Children's Hospital | Birmingham | B4 6NH | United Kingdom |
| Bristol Royal Hospital For Children | Bristol | BS2 8BJ | United Kingdom |
| Royal Hospital For Sick Children; Dept. of Child Health | Glasgow | G3 8SJ | United Kingdom |
| Received Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Follow-up Period |
|
Baseline measures were based on the Intent-to-treat population that included all enrolled patients who had taken at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Valganciclovir | Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance]. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||||||||||
| 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 | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. | Safety Population included all enrolled patients who received at least one dose of study medication and had at least one post-baseline assessment of safety. | Posted | Number | Participants | 52 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator | A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection. | Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication. | Posted | Number | Participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator | A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever ≥ 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis ≥ 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction. | Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication. | Posted | Number | Participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant | Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories < 150 CP/mL and above. | ITT population included all enrolled patients who had taken at least one dose of study medication. | Posted | Number | Participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Biopsy Proven Rejection | Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997. | ITT population included all enrolled patients who had taken at least one dose of study medication. | Posted | Number | Participants | 52 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Graft Loss | Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation. | ITT population included all enrolled patients who had taken at least one dose of study medication. | Posted | Number | Participants | 52 Weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Death | ITT population included all enrolled patients who had taken at least one dose of study medication. | Posted | Number | Participants | 52 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes) | All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir. | All patients meeting the resistance analysis criteria are included into the resistance analysis. | Posted | Number | Participants | 52 Weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Valganciclovir | Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance]. | 41 | 56 | 56 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bacterial Pyelonephritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Chronic Sinusitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea Infectious | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis Norovirus | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal Protozoal Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal Viral Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia Mycoplasmal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia Respiratory Syncytial Viral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Rotavirus Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bladder Dysfunction | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neurogenic Bladder | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ureteric Obstruction | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urethral Obstruction | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary Tract Obstruction | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vesicoureteric Reflux | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| HLA Marker Study Positive | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Transplant Rejection | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Kidney Transplant Rejection | Immune system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Type 1 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Aphthous Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Complications Of Transplant Surgery | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Complications Of Transplanted Kidney | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Benign Intracranial Hypertension | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Device Leakage | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tonsillar Hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vesicoureteral Reflux Surgery | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Renal tubular acidosis | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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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 | Hoffman-LaRoche | 800-821-8590 |
| 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 |
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| 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
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| Title | Denominators | Categories | ||||
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