Trial Outcomes & Findings for IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients (NCT NCT00294515)
NCT ID: NCT00294515
Last Updated: 2018-03-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
326 participants
Primary outcome timeframe
12 months post-transplant
Results posted on
2018-03-29
Participant Flow
Participant milestones
| Measure |
Valganciclovir up to 100 Days
900 mg valganciclovir orally daily for up to 100 days
|
Valganciclovir up to 200 Days
900 mg valganciclovir orally daily for up to 200 days
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
160
|
|
Overall Study
COMPLETED
|
132
|
132
|
|
Overall Study
NOT COMPLETED
|
34
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
Baseline characteristics by cohort
| Measure |
Valganciclovir up to 100 Days
n=164 Participants
900 mg valganciclovir orally daily for up to 100 days
|
Valganciclovir up to 200 Days
n=156 Participants
900 mg valganciclovir orally daily for up to 200 days
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 13.76 • n=99 Participants
|
47.0 years
STANDARD_DEVIATION 13.51 • n=107 Participants
|
47.8 years
STANDARD_DEVIATION 13.64 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
235 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 months post-transplantPopulation: Intent-to-treat population
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.
Outcome measures
| Measure |
Valganciclovir up to 100 Days
n=163 Participants
900 mg valganciclovir orally daily for up to 100 days
|
Valganciclovir up to 200 Days
n=155 Participants
900 mg valganciclovir orally daily for up to 200 days
|
|---|---|---|
|
Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant
|
43.6 Percentage of patients
Interval 35.8 to 51.5
|
23.9 Percentage of patients
Interval 17.4 to 31.4
|
SECONDARY outcome
Timeframe: 6 months post-transplantPopulation: Intent-to-treat population
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.
Outcome measures
| Measure |
Valganciclovir up to 100 Days
n=163 Participants
900 mg valganciclovir orally daily for up to 100 days
|
Valganciclovir up to 200 Days
n=155 Participants
900 mg valganciclovir orally daily for up to 200 days
|
|---|---|---|
|
Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant
|
36.2 Percentage of patients
Interval 28.8 to 44.1
|
10.3 Percentage of patients
Interval 6.0 to 16.2
|
SECONDARY outcome
Timeframe: 9 months post-transplantPopulation: Intent-to-treat population
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.
Outcome measures
| Measure |
Valganciclovir up to 100 Days
n=163 Participants
900 mg valganciclovir orally daily for up to 100 days
|
Valganciclovir up to 200 Days
n=155 Participants
900 mg valganciclovir orally daily for up to 200 days
|
|---|---|---|
|
Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant
|
43.6 Percentage of patients
Interval 35.8 to 51.5
|
22.6 Percentage of patients
Interval 16.3 to 30.0
|
SECONDARY outcome
Timeframe: 18 months post-transplantPopulation: Intent-to-treat population
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.
Outcome measures
| Measure |
Valganciclovir up to 100 Days
n=163 Participants
900 mg valganciclovir orally daily for up to 100 days
|
Valganciclovir up to 200 Days
n=155 Participants
900 mg valganciclovir orally daily for up to 200 days
|
|---|---|---|
|
Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant
|
47.9 Percentage of patients
Interval 40.0 to 55.8
|
34.2 Percentage of patients
Interval 26.8 to 42.2
|
SECONDARY outcome
Timeframe: 24 months post-transplantPopulation: Intent-to-treat population
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.
Outcome measures
| Measure |
Valganciclovir up to 100 Days
n=163 Participants
900 mg valganciclovir orally daily for up to 100 days
|
Valganciclovir up to 200 Days
n=155 Participants
900 mg valganciclovir orally daily for up to 200 days
|
|---|---|---|
|
Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant
|
48.5 Percentage of patients
Interval 40.6 to 56.4
|
34.2 Percentage of patients
Interval 26.8 to 42.2
|
Adverse Events
Valganciclovir up to 100 Days
Serious events: 94 serious events
Other events: 133 other events
Deaths: 0 deaths
Valganciclovir up to 200 Days
Serious events: 78 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valganciclovir up to 100 Days
n=164 participants at risk
900 mg valganciclovir orally daily for up to 100 days
|
Valganciclovir up to 200 Days
n=156 participants at risk
900 mg valganciclovir orally daily for up to 200 days
|
|---|---|---|
|
Infections and infestations
Cytomegalovirus Infection
|
12.8%
21/164
Safety Population
|
3.2%
5/156
Safety Population
|
|
Infections and infestations
Urinary Tract Infection
|
4.3%
7/164
Safety Population
|
6.4%
10/156
Safety Population
|
|
Infections and infestations
Cytomegalovirus Syndrome
|
7.3%
12/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Gastroenteritis
|
1.2%
2/164
Safety Population
|
1.9%
3/156
Safety Population
|
|
Infections and infestations
Pyelonephritis Acute
|
1.2%
2/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Infections and infestations
Sepsis
|
0.61%
1/164
Safety Population
|
1.9%
3/156
Safety Population
|
|
Infections and infestations
Pneumonia
|
0.61%
1/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Infections and infestations
Cytomegalovirus Viraemia
|
1.2%
2/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Wound Infection
|
0.61%
1/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Bacterial Infection
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Bronchopneumonia
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Campylobacter Infection
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Cellulitis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Cytomegalovirus Colitis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Cytomegalovirus Hepatitis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Erysipelas
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Febrile Infection
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Folliculitis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Klebsiella Infection
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Lung Infection Pseudomonal
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Perirectal Abscess
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Septic Shock
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Subcutaneous Abscess
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Infections and infestations
Urosepsis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.4%
4/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Renal and urinary disorders
Renal Impairment
|
1.8%
3/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Renal and urinary disorders
Haematuria
|
0.61%
1/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.61%
1/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Renal and urinary disorders
Ureteric Stenosis
|
0.61%
1/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Renal and urinary disorders
Hydronephrosis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Renal and urinary disorders
Renal Tubular Disorder
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Renal and urinary disorders
Renal Vein Thrombosis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/164
Safety Population
|
2.6%
4/156
Safety Population
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.61%
1/164
Safety Population
|
1.9%
3/156
Safety Population
|
|
Gastrointestinal disorders
Pancreatitis
|
1.2%
2/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Gastrointestinal disorders
Oral Pain
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Immune system disorders
Transplant Rejection
|
6.7%
11/164
Safety Population
|
5.1%
8/156
Safety Population
|
|
Immune system disorders
Kidney Transplant Rejection
|
1.8%
3/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Immune system disorders
Food Allergy
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
3/164
Safety Population
|
5.8%
9/156
Safety Population
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.61%
1/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
2/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
General disorders
Pyrexia
|
1.8%
3/164
Safety Population
|
2.6%
4/156
Safety Population
|
|
General disorders
Chest Pain
|
0.00%
0/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
General disorders
Impaired Healing
|
0.00%
0/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
General disorders
Malaise
|
0.00%
0/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
General disorders
Asthenia
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
General disorders
Catheter Related Complication
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
General disorders
Catheter Site Discharge
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
General disorders
Multi-organ Failure
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
General disorders
Oedema Peripheral
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Investigations
Blood Creatinine Increased
|
6.1%
10/164
Safety Population
|
5.1%
8/156
Safety Population
|
|
Vascular disorders
Lymphocele
|
1.2%
2/164
Safety Population
|
1.9%
3/156
Safety Population
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.2%
2/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Vascular disorders
Hypotension
|
1.2%
2/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Vascular disorders
Phlebitis
|
1.2%
2/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Vascular disorders
Arterial Stenosis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Vascular disorders
Haemorrhage
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Vascular disorders
Shock Haemorrhagic
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Vascular disorders
Venous Thrombosis
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Injury, poisoning and procedural complications
Complications of Transplanted Kidney
|
1.2%
2/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Injury, poisoning and procedural complications
Graft Dysfunction
|
0.00%
0/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Injury, poisoning and procedural complications
Complications of Transplant Surgery
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Injury, poisoning and procedural complications
Medical Device Complication
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Injury, poisoning and procedural complications
Overdose
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Injury, poisoning and procedural complications
Post Procedural Fistula
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Injury, poisoning and procedural complications
Ureteric Anastomosis Complication
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
4/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.61%
1/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Cardiac disorders
Arrhythmia
|
0.61%
1/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Cardiac disorders
Arrhythmia Supraventricular
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Cardiac disorders
Cardiac Failure
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Cardiac disorders
Mitral Valve Disease
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Cardiac disorders
Pericardial Effusion
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Cardiac disorders
Tachycardia
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.61%
1/164
Safety Population
|
1.3%
2/156
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.61%
1/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage
|
0.61%
1/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Nervous system disorders
Clonus
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Nervous system disorders
Tremor
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Congenital, familial and genetic disorders
Hereditary Haemorrhagic Telangiectasia
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Congenital, familial and genetic disorders
Renal Arteriovenous Malformation
|
0.00%
0/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.61%
1/164
Safety Population
|
0.64%
1/156
Safety Population
|
|
Endocrine disorders
Hyperparathyroidism
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
|
Surgical and medical procedures
Ureteral Stent Removal
|
0.61%
1/164
Safety Population
|
0.00%
0/156
Safety Population
|
Other adverse events
| Measure |
Valganciclovir up to 100 Days
n=164 participants at risk
900 mg valganciclovir orally daily for up to 100 days
|
Valganciclovir up to 200 Days
n=156 participants at risk
900 mg valganciclovir orally daily for up to 200 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
41/164
Safety Population
|
37.2%
58/156
Safety Population
|
|
Blood and lymphatic system disorders
Anaemia
|
17.7%
29/164
Safety Population
|
15.4%
24/156
Safety Population
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.4%
22/164
Safety Population
|
10.3%
16/156
Safety Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
6/164
Safety Population
|
5.1%
8/156
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
41/164
Safety Population
|
30.8%
48/156
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
14.6%
24/164
Safety Population
|
9.0%
14/156
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
11.0%
18/164
Safety Population
|
10.9%
17/156
Safety Population
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.3%
12/164
Safety Population
|
5.1%
8/156
Safety Population
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
6/164
Safety Population
|
6.4%
10/156
Safety Population
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.3%
7/164
Safety Population
|
5.1%
8/156
Safety Population
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
3/164
Safety Population
|
7.1%
11/156
Safety Population
|
|
Infections and infestations
Urinary Tract Infection
|
12.2%
20/164
Safety Population
|
18.6%
29/156
Safety Population
|
|
Infections and infestations
Nasopharyngitis
|
10.4%
17/164
Safety Population
|
7.7%
12/156
Safety Population
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.5%
14/164
Safety Population
|
9.0%
14/156
Safety Population
|
|
General disorders
Oedema Peripheral
|
21.3%
35/164
Safety Population
|
19.2%
30/156
Safety Population
|
|
General disorders
Pyrexia
|
10.4%
17/164
Safety Population
|
6.4%
10/156
Safety Population
|
|
General disorders
Fatigue
|
4.3%
7/164
Safety Population
|
9.0%
14/156
Safety Population
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.2%
20/164
Safety Population
|
11.5%
18/156
Safety Population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.2%
20/164
Safety Population
|
9.0%
14/156
Safety Population
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.4%
17/164
Safety Population
|
6.4%
10/156
Safety Population
|
|
Nervous system disorders
Tremor
|
11.6%
19/164
Safety Population
|
16.0%
25/156
Safety Population
|
|
Nervous system disorders
Headache
|
9.8%
16/164
Safety Population
|
5.8%
9/156
Safety Population
|
|
Vascular disorders
Hypertension
|
12.8%
21/164
Safety Population
|
12.2%
19/156
Safety Population
|
|
Vascular disorders
Hypotension
|
6.1%
10/164
Safety Population
|
1.9%
3/156
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.4%
17/164
Safety Population
|
4.5%
7/156
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
9/164
Safety Population
|
3.8%
6/156
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.7%
6/164
Safety Population
|
5.1%
8/156
Safety Population
|
|
Psychiatric disorders
Insomnia
|
7.3%
12/164
Safety Population
|
6.4%
10/156
Safety Population
|
|
Investigations
Blood Creatinine Increased
|
6.7%
11/164
Safety Population
|
5.8%
9/156
Safety Population
|
|
Renal and urinary disorders
Haematuria
|
4.3%
7/164
Safety Population
|
5.8%
9/156
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
9/164
Safety Population
|
3.2%
5/156
Safety Population
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER