IMPACT Study: A Study of Valcyte (Valganciclovir) for Pre... | NCT00294515

Label	Type	Description	Intervention Names
Valganciclovir up to 100 days	Experimental	Valganciclovir for up to 100 days post kidney transplant	Drug: Valganciclovir
Valganciclovir up to 200 days	Active Comparator	Valganciclovir for up to 200 days post kidney transplant	Drug: Valganciclovir

Name	Type	Description	Arm Group Labels	Other Names
Valganciclovir	Drug	900 mg orally daily for up to 100 days	Valganciclovir up to 100 days

Measure	Description	Time Frame
Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant	Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.	12 months post-transplant

Measure	Description	Time Frame
Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant	Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.	6 months post-transplant
Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Uni of Alabama At Birmingham		Birmingham	Alabama	35294	United States
National Institute of Transplantation

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

ID	Title	Description
FG000	Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days
FG001	Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days

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 Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant

Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 12 months post-transplant.

Intent-to-treat population

Posted

Mean

95% Confidence Interval

Percentage of patients

12 months post-transplant

ID	Title	Description
OG000	Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days
OG001	Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days

Units	Counts
Participants	OG000163 OG001155

Title

Denominators

Categories

Title	Measurements
	OG00043.6(35.8 to 51.5) OG00123.9(17.4 to 31.4)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel	Stratified by Center Pools	<=0.0002		Odds Ratio (OR)	0.40			2-Sided	95	0.25	0.66					Superiority or Other

Secondary

Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant

Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 6 months post-transplant.

Intent-to-treat population

Posted

Mean

95% Confidence Interval

Percentage of patients

6 months post-transplant

ID	Title	Description
OG000	Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days
OG001	Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant

Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 9 months post-transplant.

Intent-to-treat population

Posted

Mean

95% Confidence Interval

Percentage of patients

9 months post-transplant

ID	Title	Description
OG000	Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days
OG001	Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant

Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 18 months post-transplant.

Intent-to-treat population

Posted

Mean

95% Confidence Interval

Percentage of patients

18 months post-transplant

ID	Title	Description
OG000	Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days
OG001	Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant

Percentage of CMV-seronegative renal transplant recipients (R-) receiving a CMV-seropositive graft (D+) who developed CMV disease (confirmed and assumed) within 24 months post-transplant.

Intent-to-treat population

Posted

Mean

95% Confidence Interval

Percentage of patients

24 months post-transplant

ID	Title	Description
OG000	Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days
OG001	Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Statistical Information
Cytomegalovirus Infection	Infections and infestations	EG00021 affected164 at risk EG0015 affected156 at risk
Urinary Tract Infection	Infections and infestations	EG0007 affected164 at risk EG00110 affected156 at risk
Cytomegalovirus Syndrome	Infections and infestations	EG00012 affected164 at risk EG0011 affected156 at risk
Gastroenteritis	Infections and infestations	EG0002 affected164 at risk EG0013 affected156 at risk
Pyelonephritis Acute	Infections and infestations	EG0002 affected164 at risk EG0012 affected156 at risk
Sepsis	Infections and infestations	EG0001 affected164 at risk EG0013 affected156 at risk
Pneumonia	Infections and infestations	EG0001 affected164 at risk EG0012 affected156 at risk
Cytomegalovirus Viraemia	Infections and infestations	EG0002 affected164 at risk EG0010 affected156 at risk
Wound Infection	Infections and infestations	EG0001 affected164 at risk EG0011 affected156 at risk
Abscess Limb	Infections and infestations	EG0000 affected164 at risk EG0011 affected156 at risk
Bacterial Infection	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Bronchopneumonia	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Campylobacter Infection	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Cellulitis	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Cytomegalovirus Colitis	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Cytomegalovirus Hepatitis	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Erysipelas	Infections and infestations	EG0000 affected164 at risk EG0011 affected156 at risk
Escherichia Sepsis	Infections and infestations	EG0000 affected164 at risk EG0011 affected156 at risk
Escherichia Urinary Tract Infection	Infections and infestations	EG0000 affected164 at risk EG0011 affected156 at risk
Febrile Infection	Infections and infestations	EG0000 affected164 at risk EG0011 affected156 at risk
Folliculitis	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Klebsiella Infection	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Lung Infection Pseudomonal	Infections and infestations	EG0000 affected164 at risk EG0011 affected156 at risk
Mediastinitis	Infections and infestations	EG0000 affected164 at risk EG0011 affected156 at risk
Perirectal Abscess	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Pneumonia Streptococcal	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Pyelonephritis	Infections and infestations	EG0000 affected164 at risk EG0011 affected156 at risk
Septic Shock	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Subcutaneous Abscess	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG0000 affected164 at risk EG0011 affected156 at risk
Urosepsis	Infections and infestations	EG0001 affected164 at risk EG0010 affected156 at risk
Renal Failure Acute	Renal and urinary disorders	EG0004 affected164 at risk EG0012 affected156 at risk
Renal Impairment	Renal and urinary disorders	EG0003 affected164 at risk EG0012 affected156 at risk
Haematuria	Renal and urinary disorders	EG0001 affected164 at risk EG0011 affected156 at risk
Ureteric Obstruction	Renal and urinary disorders	EG0001 affected164 at risk EG0011 affected156 at risk
Ureteric Stenosis	Renal and urinary disorders	EG0001 affected164 at risk EG0011 affected156 at risk
Hydronephrosis	Renal and urinary disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Renal Artery Stenosis	Renal and urinary disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Renal Failure	Renal and urinary disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Renal Tubular Disorder	Renal and urinary disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Renal Tubular Necrosis	Renal and urinary disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Renal Vein Thrombosis	Renal and urinary disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Diarrhoea	Gastrointestinal disorders	EG0002 affected164 at risk EG0014 affected156 at risk
Abdominal Pain	Gastrointestinal disorders	EG0001 affected164 at risk EG0013 affected156 at risk
Pancreatitis	Gastrointestinal disorders	EG0002 affected164 at risk EG0010 affected156 at risk
Abdominal Pain Upper	Gastrointestinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Colitis	Gastrointestinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Constipation	Gastrointestinal disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Gastric Ulcer	Gastrointestinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Impaired Gastric Emptying	Gastrointestinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Inguinal Hernia	Gastrointestinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Intestinal Ischaemia	Gastrointestinal disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Large Intestine Perforation	Gastrointestinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Mouth Ulceration	Gastrointestinal disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Oral Pain	Gastrointestinal disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Pancreatitis Acute	Gastrointestinal disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Transplant Rejection	Immune system disorders	EG00011 affected164 at risk EG0018 affected156 at risk
Kidney Transplant Rejection	Immune system disorders	EG0003 affected164 at risk EG0010 affected156 at risk
Food Allergy	Immune system disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Neutropenia	Blood and lymphatic system disorders	EG0003 affected164 at risk EG0019 affected156 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	EG0001 affected164 at risk EG0012 affected156 at risk
Leukopenia	Blood and lymphatic system disorders	EG0002 affected164 at risk EG0011 affected156 at risk
Agranulocytosis	Blood and lymphatic system disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Anaemia	Blood and lymphatic system disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Bicytopenia	Blood and lymphatic system disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Haemolytic Anaemia	Blood and lymphatic system disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Pyrexia	General disorders	EG0003 affected164 at risk EG0014 affected156 at risk
Chest Pain	General disorders	EG0000 affected164 at risk EG0012 affected156 at risk
Impaired Healing	General disorders	EG0000 affected164 at risk EG0012 affected156 at risk
Malaise	General disorders	EG0000 affected164 at risk EG0012 affected156 at risk
Asthenia	General disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Catheter Related Complication	General disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Catheter Site Discharge	General disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Multi-organ Failure	General disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Non-cardiac Chest Pain	General disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Oedema Peripheral	General disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Blood Creatinine Increased	Investigations	EG00010 affected164 at risk EG0018 affected156 at risk
Lymphocele	Vascular disorders	EG0002 affected164 at risk EG0013 affected156 at risk
Deep Vein Thrombosis	Vascular disorders	EG0002 affected164 at risk EG0011 affected156 at risk
Hypotension	Vascular disorders	EG0002 affected164 at risk EG0010 affected156 at risk
Phlebitis	Vascular disorders	EG0002 affected164 at risk EG0010 affected156 at risk
Arterial Stenosis	Vascular disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Haemorrhage	Vascular disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Iliac Artery Stenosis	Vascular disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Shock Haemorrhagic	Vascular disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Venous Thrombosis	Vascular disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Complications of Transplanted Kidney	Injury, poisoning and procedural complications	EG0002 affected164 at risk EG0011 affected156 at risk
Graft Dysfunction	Injury, poisoning and procedural complications	EG0000 affected164 at risk EG0012 affected156 at risk
Complications of Transplant Surgery	Injury, poisoning and procedural complications	EG0001 affected164 at risk EG0010 affected156 at risk
Contusion	Injury, poisoning and procedural complications	EG0000 affected164 at risk EG0011 affected156 at risk
Hip Fracture	Injury, poisoning and procedural complications	EG0001 affected164 at risk EG0010 affected156 at risk
Medical Device Complication	Injury, poisoning and procedural complications	EG0000 affected164 at risk EG0011 affected156 at risk
Overdose	Injury, poisoning and procedural complications	EG0001 affected164 at risk EG0010 affected156 at risk
Post Procedural Fistula	Injury, poisoning and procedural complications	EG0001 affected164 at risk EG0010 affected156 at risk
Ureteric Anastomosis Complication	Injury, poisoning and procedural complications	EG0000 affected164 at risk EG0011 affected156 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	EG0001 affected164 at risk EG0010 affected156 at risk
Wound Secretion	Injury, poisoning and procedural complications	EG0000 affected164 at risk EG0011 affected156 at risk
Dehydration	Metabolism and nutrition disorders	EG0004 affected164 at risk EG0011 affected156 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	EG0000 affected164 at risk EG0012 affected156 at risk
Hyperkalaemia	Metabolism and nutrition disorders	EG0001 affected164 at risk EG0011 affected156 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Hypoglycaemia	Metabolism and nutrition disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Acute Coronary Syndrome	Cardiac disorders	EG0000 affected164 at risk EG0012 affected156 at risk
Arrhythmia	Cardiac disorders	EG0001 affected164 at risk EG0011 affected156 at risk
Myocardial Infarction	Cardiac disorders	EG0000 affected164 at risk EG0012 affected156 at risk
Angina Pectoris	Cardiac disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Arrhythmia Supraventricular	Cardiac disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Cardiac Failure	Cardiac disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Mitral Valve Disease	Cardiac disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Pericardial Effusion	Cardiac disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Tachycardia	Cardiac disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	EG0001 affected164 at risk EG0012 affected156 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	EG0001 affected164 at risk EG0011 affected156 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Muscle Haemorrhage	Musculoskeletal and connective tissue disorders	EG0001 affected164 at risk EG0011 affected156 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Cerebrovascular Accident	Nervous system disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Clonus	Nervous system disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Neuropathy Peripheral	Nervous system disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Tremor	Nervous system disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Hereditary Haemorrhagic Telangiectasia	Congenital, familial and genetic disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Renal Arteriovenous Malformation	Congenital, familial and genetic disorders	EG0000 affected164 at risk EG0011 affected156 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	EG0001 affected164 at risk EG0011 affected156 at risk
Hyperparathyroidism	Endocrine disorders	EG0001 affected164 at risk EG0010 affected156 at risk
Ureteral Stent Removal	Surgical and medical procedures	EG0001 affected164 at risk EG0010 affected156 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Leukopenia	Blood and lymphatic system disorders	EG00041 affected164 at risk EG00158 affected156 at risk
Anaemia	Blood and lymphatic system disorders	EG00029 affected164 at risk EG00124 affected156 at risk
Neutropenia	Blood and lymphatic system disorders	EG00022 affected164 at risk EG00116 affected156 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0006 affected164 at risk EG0018 affected156 at risk
Diarrhoea	Gastrointestinal disorders	EG00041 affected164 at risk EG00148 affected156 at risk
Constipation	Gastrointestinal disorders	EG00024 affected164 at risk EG00114 affected156 at risk
Nausea	Gastrointestinal disorders	EG00018 affected164 at risk EG00117 affected156 at risk
Abdominal Pain	Gastrointestinal disorders	EG00012 affected164 at risk EG0018 affected156 at risk
Vomiting	Gastrointestinal disorders	EG0006 affected164 at risk EG00110 affected156 at risk
Abdominal Pain Upper	Gastrointestinal disorders	EG0007 affected164 at risk EG0018 affected156 at risk
Dyspepsia	Gastrointestinal disorders	EG0003 affected164 at risk EG00111 affected156 at risk
Urinary Tract Infection	Infections and infestations	EG00020 affected164 at risk EG00129 affected156 at risk
Nasopharyngitis	Infections and infestations	EG00017 affected164 at risk EG00112 affected156 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG00014 affected164 at risk EG00114 affected156 at risk
Oedema Peripheral	General disorders	EG00035 affected164 at risk EG00130 affected156 at risk
Pyrexia	General disorders	EG00017 affected164 at risk EG00110 affected156 at risk
Fatigue	General disorders	EG0007 affected164 at risk EG00114 affected156 at risk
Hypophosphataemia	Metabolism and nutrition disorders	EG00020 affected164 at risk EG00118 affected156 at risk
Hyperkalaemia	Metabolism and nutrition disorders	EG00020 affected164 at risk EG00114 affected156 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	EG00017 affected164 at risk EG00110 affected156 at risk
Tremor	Nervous system disorders	EG00019 affected164 at risk EG00125 affected156 at risk
Headache	Nervous system disorders	EG00016 affected164 at risk EG0019 affected156 at risk
Hypertension	Vascular disorders	EG00021 affected164 at risk EG00119 affected156 at risk
Hypotension	Vascular disorders	EG00010 affected164 at risk EG0013 affected156 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG00017 affected164 at risk EG0017 affected156 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0009 affected164 at risk EG0016 affected156 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	EG0006 affected164 at risk EG0018 affected156 at risk
Insomnia	Psychiatric disorders	EG00012 affected164 at risk EG00110 affected156 at risk
Blood Creatinine Increased	Investigations	EG00011 affected164 at risk EG0019 affected156 at risk
Haematuria	Renal and urinary disorders	EG0007 affected164 at risk EG0019 affected156 at risk
Rash	Skin and subcutaneous tissue disorders	EG0009 affected164 at risk EG0015 affected156 at risk

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

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

ID	Title	Description
BG000	Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days
BG001	Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days			94	164	133	164
EG001	Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days			78	156	141	156