Trial Outcomes & Findings for A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients (NCT NCT01769170)
NCT ID: NCT01769170
Last Updated: 2021-07-21
Results Overview
Clinically significant cytomegalovirus (CMV) infection was defined by either of the following outcomes: 1. Onset of CMV end-organ disease; or 2. Initiation of anti-CMV-specific preemptive therapy based on documented CMV viremia (as measured by the central virology laboratory) and the clinical condition of the subject. CMV viremia (i.e., the measurement of CMV DNA in plasma) was determined by the designated central virology laboratory at all scheduled visits via quantitative polymerase chain reaction (qPCR) testing using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
452 participants
Primary outcome timeframe
24 weeks
Results posted on
2021-07-21
Participant Flow
Participant milestones
| Measure |
Brincidofovir
100 mg brincidofovir administered orally twice weekly
|
Placebo
Matching placebo administered orally twice weekly
|
|---|---|---|
|
Overall Study
STARTED
|
303
|
149
|
|
Overall Study
COMPLETED
|
232
|
122
|
|
Overall Study
NOT COMPLETED
|
71
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients
Baseline characteristics by cohort
| Measure |
Brincidofovir
n=303 Participants
100 mg brincidofovir administered orally twice weekly
|
Placebo
n=149 Participants
Matching placebo administered orally twice weekly
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 14.29 • n=99 Participants
|
51.9 years
STANDARD_DEVIATION 15.03 • n=107 Participants
|
52.6 years
STANDARD_DEVIATION 14.53 • n=206 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
261 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
191 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intent-to-Treat Analysis Set, which included all subjects who received at least 1 dose of study drug.
Clinically significant cytomegalovirus (CMV) infection was defined by either of the following outcomes: 1. Onset of CMV end-organ disease; or 2. Initiation of anti-CMV-specific preemptive therapy based on documented CMV viremia (as measured by the central virology laboratory) and the clinical condition of the subject. CMV viremia (i.e., the measurement of CMV DNA in plasma) was determined by the designated central virology laboratory at all scheduled visits via quantitative polymerase chain reaction (qPCR) testing using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test.
Outcome measures
| Measure |
Brincidofovir
n=303 Participants
100 mg brincidofovir administered orally twice weekly
|
Placebo
n=149 Participants
Matching placebo administered orally twice weekly
|
|---|---|---|
|
Number of Participants With Clinically Significant CMV Infection Through Week 24 Post-Transplant
|
155 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Intention-to-Treat Analysis Set, which included all randomized subjects who received at least 1 dose of study drug.
The incidence of clinically significant cytomegalovirus (CMV) infection through Week 14. Blood and urine for virologic evaluations were collected at screening, pre-dose on the first day of study drug administration, and at pre-specified intervals throughout the treatment phases of the study and sent to a designated central virology laboratory for analysis. Blood samples were used for real-time assay of CMV viremia in plasma using a qPCR assay. Urine samples were stored for possible future retrospective analyses of CMV.
Outcome measures
| Measure |
Brincidofovir
n=303 Participants
100 mg brincidofovir administered orally twice weekly
|
Placebo
n=149 Participants
Matching placebo administered orally twice weekly
|
|---|---|---|
|
Incidence of Clinically Significant CMV Infection Through Week 14
|
74 Participants
|
57 Participants
|
Adverse Events
Brincidofovir
Serious events: 173 serious events
Other events: 302 other events
Deaths: 0 deaths
Placebo
Serious events: 56 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brincidofovir
n=303 participants at risk
100 mg brincidofovir administered orally twice weekly
|
Placebo
n=149 participants at risk
Matching placebo administered orally twice weekly
|
|---|---|---|
|
Immune system disorders
Acute graft versus host disease
|
32.3%
98/303
|
6.0%
9/149
|
|
Immune system disorders
Chronic graft versus host disease
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Clostridium difficile colitis
|
3.0%
9/303
|
0.00%
0/149
|
|
Infections and infestations
Pneumonia
|
1.7%
5/303
|
2.7%
4/149
|
|
Infections and infestations
Cellulitis
|
0.99%
3/303
|
0.67%
1/149
|
|
Infections and infestations
BK virus infection
|
0.66%
2/303
|
0.67%
1/149
|
|
Infections and infestations
Clostridium difficile infection
|
0.66%
2/303
|
0.00%
0/149
|
|
Infections and infestations
Corona virus infection
|
0.66%
2/303
|
0.00%
0/149
|
|
Infections and infestations
Enterovirus infection
|
0.33%
1/303
|
0.67%
1/149
|
|
Infections and infestations
Metapneumovirus infection
|
0.33%
1/303
|
0.67%
1/149
|
|
Infections and infestations
Rhinovirus infection
|
0.33%
1/303
|
0.67%
1/149
|
|
Infections and infestations
Sepsis
|
0.33%
1/303
|
0.67%
1/149
|
|
Infections and infestations
Septic shock
|
0.66%
2/303
|
0.00%
0/149
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/303
|
1.3%
2/149
|
|
Infections and infestations
Staphylococcal sepsis
|
0.33%
1/303
|
0.67%
1/149
|
|
Infections and infestations
Toxoplasmosis
|
0.66%
2/303
|
0.00%
0/149
|
|
Infections and infestations
Adenovirus infection
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Bacterial infection
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Bronchopneumonia
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Cystitis viral
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Cystitis klebsiella
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Encephalitis
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Enterococcal sepsis
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Influenza
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Nocardiosis
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Perirectal abscess
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Pneumonia bacterial
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Pneumonia legionella
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Pneumonia parainfluenza viral
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Pneumonia viral
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Rotavirus infection
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Sinusitis
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Systemic candida
|
0.00%
0/303
|
0.67%
1/149
|
|
Infections and infestations
Upper respiratory tract infection
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Urinary tract infection
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
0.33%
1/303
|
0.00%
0/149
|
|
Infections and infestations
Zygomycosis
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
21/303
|
2.7%
4/149
|
|
Gastrointestinal disorders
Nausea
|
1.7%
5/303
|
0.67%
1/149
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
5/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
3/303
|
0.67%
1/149
|
|
Gastrointestinal disorders
Enteritis
|
0.66%
2/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.33%
1/303
|
0.67%
1/149
|
|
Gastrointestinal disorders
Oesophagitis
|
0.33%
1/303
|
0.67%
1/149
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Ileal perforation
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Ileus
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/303
|
0.67%
1/149
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.33%
1/303
|
0.00%
0/149
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.33%
1/303
|
0.00%
0/149
|
|
General disorders
Pyrexia
|
3.0%
9/303
|
5.4%
8/149
|
|
General disorders
Multi-organ failure
|
1.3%
4/303
|
0.67%
1/149
|
|
General disorders
Chest pain
|
0.33%
1/303
|
0.00%
0/149
|
|
General disorders
Drug withdrawal syndrome
|
0.33%
1/303
|
0.00%
0/149
|
|
General disorders
Gait disturbance
|
0.00%
0/303
|
0.67%
1/149
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/303
|
0.67%
1/149
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
6/303
|
0.67%
1/149
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
4/303
|
0.67%
1/149
|
|
Investigations
Klebsiella test positive
|
0.66%
2/303
|
0.67%
1/149
|
|
Investigations
Polyomavirus test positive
|
0.66%
2/303
|
0.67%
1/149
|
|
Investigations
Bacterial test positive
|
0.00%
0/303
|
1.3%
2/149
|
|
Investigations
Escherichia test positive
|
0.33%
1/303
|
0.67%
1/149
|
|
Investigations
Staphylococcus test positive
|
0.33%
1/303
|
0.67%
1/149
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/303
|
0.67%
1/149
|
|
Investigations
Citrobacter test positive
|
0.00%
0/303
|
0.67%
1/149
|
|
Investigations
Electrocardiogram Qt prolonged
|
0.33%
1/303
|
0.00%
0/149
|
|
Investigations
Enterococcus test positive
|
0.00%
0/303
|
0.67%
1/149
|
|
Investigations
Hepatic enzyme increased
|
0.33%
1/303
|
0.00%
0/149
|
|
Investigations
Human rhinovirus test positive
|
0.33%
1/303
|
0.00%
0/149
|
|
Investigations
Pseudomonas test positive
|
0.33%
1/303
|
0.00%
0/149
|
|
Investigations
Troponin increased
|
0.33%
1/303
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.99%
3/303
|
0.67%
1/149
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.66%
2/303
|
0.67%
1/149
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.33%
1/303
|
0.67%
1/149
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.33%
1/303
|
0.67%
1/149
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar damage
|
0.33%
1/303
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/303
|
0.67%
1/149
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
1/303
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.33%
1/303
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.33%
1/303
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.33%
1/303
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.33%
1/303
|
0.00%
0/149
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/303
|
0.67%
1/149
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
2.0%
6/303
|
2.0%
3/149
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.33%
1/303
|
0.67%
1/149
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma recurrent
|
0.33%
1/303
|
0.00%
0/149
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/303
|
0.67%
1/149
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.33%
1/303
|
0.00%
0/149
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell leukaemia
|
0.33%
1/303
|
0.00%
0/149
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.33%
1/303
|
0.00%
0/149
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
5/303
|
0.00%
0/149
|
|
Metabolism and nutrition disorders
Dehydration
|
0.99%
3/303
|
0.00%
0/149
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.33%
1/303
|
0.67%
1/149
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.33%
1/303
|
0.00%
0/149
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/303
|
0.67%
1/149
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.33%
1/303
|
0.00%
0/149
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.33%
1/303
|
0.00%
0/149
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.33%
1/303
|
0.00%
0/149
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.33%
1/303
|
0.00%
0/149
|
|
Renal and urinary disorders
Acute kidney injury
|
3.0%
9/303
|
2.7%
4/149
|
|
Renal and urinary disorders
Prerenal failure
|
0.33%
1/303
|
0.00%
0/149
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.33%
1/303
|
0.00%
0/149
|
|
Vascular disorders
Hypotension
|
0.99%
3/303
|
0.67%
1/149
|
|
Vascular disorders
Deep vein thrombosis
|
0.99%
3/303
|
0.00%
0/149
|
|
Vascular disorders
Jugular vein thrombosis
|
0.66%
2/303
|
0.00%
0/149
|
|
Vascular disorders
Orthostatic hypotension
|
0.33%
1/303
|
0.67%
1/149
|
|
Vascular disorders
Haematoma
|
0.33%
1/303
|
0.00%
0/149
|
|
Vascular disorders
Hypertension
|
0.33%
1/303
|
0.00%
0/149
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/303
|
0.67%
1/149
|
|
Vascular disorders
Thrombosis
|
0.33%
1/303
|
0.00%
0/149
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
6/303
|
0.67%
1/149
|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/303
|
0.67%
1/149
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.33%
1/303
|
0.67%
1/149
|
|
Blood and lymphatic system disorders
Microangiopathic haemolytic anaemia
|
0.00%
0/303
|
0.67%
1/149
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.33%
1/303
|
0.00%
0/149
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/303
|
0.67%
1/149
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
4/303
|
0.00%
0/149
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.99%
3/303
|
0.00%
0/149
|
|
Cardiac disorders
Atrial fibrillation
|
0.33%
1/303
|
0.67%
1/149
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/303
|
0.67%
1/149
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/303
|
0.67%
1/149
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/303
|
0.67%
1/149
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.33%
1/303
|
0.00%
0/149
|
|
Cardiac disorders
Intracardiac thrombus
|
0.33%
1/303
|
0.00%
0/149
|
|
Cardiac disorders
Pericardial effusion
|
0.33%
1/303
|
0.00%
0/149
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/303
|
0.67%
1/149
|
|
Cardiac disorders
Pulseless electrical activity
|
0.33%
1/303
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
4/303
|
0.67%
1/149
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.66%
2/303
|
1.3%
2/149
|
|
Injury, poisoning and procedural complications
Delayed engraftment
|
0.33%
1/303
|
0.67%
1/149
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.33%
1/303
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/303
|
0.67%
1/149
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.33%
1/303
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/303
|
0.67%
1/149
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.33%
1/303
|
0.00%
0/149
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.33%
1/303
|
0.00%
0/149
|
|
Nervous system disorders
Headache
|
0.99%
3/303
|
0.00%
0/149
|
|
Nervous system disorders
Syncope
|
0.66%
2/303
|
0.67%
1/149
|
|
Nervous system disorders
Seizure
|
0.33%
1/303
|
0.67%
1/149
|
|
Nervous system disorders
Arachnoiditis
|
0.00%
0/303
|
0.67%
1/149
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/303
|
0.00%
0/149
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.33%
1/303
|
0.00%
0/149
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/303
|
0.67%
1/149
|
|
Nervous system disorders
Tremor
|
0.33%
1/303
|
0.00%
0/149
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.66%
2/303
|
0.67%
1/149
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.66%
2/303
|
0.00%
0/149
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.33%
1/303
|
0.67%
1/149
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.33%
1/303
|
0.00%
0/149
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/303
|
0.67%
1/149
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.33%
1/303
|
0.00%
0/149
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/303
|
0.67%
1/149
|
|
Psychiatric disorders
Mental status changes
|
1.3%
4/303
|
0.00%
0/149
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/303
|
0.67%
1/149
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.66%
2/303
|
0.00%
0/149
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.33%
1/303
|
0.00%
0/149
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.33%
1/303
|
0.00%
0/149
|
|
Endocrine disorders
Adrenal insufficiency
|
0.33%
1/303
|
0.00%
0/149
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.33%
1/303
|
0.00%
0/149
|
Other adverse events
| Measure |
Brincidofovir
n=303 participants at risk
100 mg brincidofovir administered orally twice weekly
|
Placebo
n=149 participants at risk
Matching placebo administered orally twice weekly
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
60.7%
184/303
|
36.2%
54/149
|
|
Gastrointestinal disorders
Abdominal pain
|
34.3%
104/303
|
17.4%
26/149
|
|
Gastrointestinal disorders
Nausea
|
30.7%
93/303
|
19.5%
29/149
|
|
Gastrointestinal disorders
Vomiting
|
24.4%
74/303
|
16.8%
25/149
|
|
Gastrointestinal disorders
Constipation
|
9.6%
29/303
|
7.4%
11/149
|
|
Gastrointestinal disorders
Dry mouth
|
6.9%
21/303
|
8.7%
13/149
|
|
Gastrointestinal disorders
Abdominal distension
|
6.3%
19/303
|
6.7%
10/149
|
|
Gastrointestinal disorders
Dyspepsia
|
7.9%
24/303
|
2.7%
4/149
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.1%
67/303
|
12.8%
19/149
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.8%
48/303
|
7.4%
11/149
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.5%
47/303
|
6.7%
10/149
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
38/303
|
8.1%
12/149
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.9%
21/303
|
5.4%
8/149
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.6%
20/303
|
4.0%
6/149
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.9%
21/303
|
3.4%
5/149
|
|
Metabolism and nutrition disorders
Dehydration
|
6.6%
20/303
|
3.4%
5/149
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.3%
19/303
|
2.7%
4/149
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.6%
17/303
|
2.7%
4/149
|
|
General disorders
Fatigue
|
13.9%
42/303
|
18.8%
28/149
|
|
General disorders
Oedema peripheral
|
17.2%
52/303
|
12.1%
18/149
|
|
General disorders
Pyrexia
|
13.9%
42/303
|
18.1%
27/149
|
|
General disorders
Mucosal inflammation
|
10.6%
32/303
|
10.1%
15/149
|
|
General disorders
Asthenia
|
9.6%
29/303
|
4.0%
6/149
|
|
Immune system disorders
Acute graft versus host disease
|
57.1%
173/303
|
32.2%
48/149
|
|
Immune system disorders
Hypogammaglobulinaemia
|
5.3%
16/303
|
4.0%
6/149
|
|
Infections and infestations
BK virus infection
|
7.9%
24/303
|
4.7%
7/149
|
|
Infections and infestations
Clostridium difficile colitis
|
8.9%
27/303
|
2.0%
3/149
|
|
Infections and infestations
Cystitis viral
|
5.6%
17/303
|
2.7%
4/149
|
|
Investigations
Alanine aminotransferase increased
|
11.2%
34/303
|
6.0%
9/149
|
|
Investigations
Aspartate aminotransferase increased
|
9.6%
29/303
|
5.4%
8/149
|
|
Investigations
Blood creatinine increased
|
7.9%
24/303
|
8.1%
12/149
|
|
Investigations
Weight decreased
|
7.9%
24/303
|
1.3%
2/149
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.2%
43/303
|
18.8%
28/149
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.6%
29/303
|
8.7%
13/149
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.9%
27/303
|
5.4%
8/149
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
16/303
|
2.7%
4/149
|
|
Nervous system disorders
Headache
|
10.2%
31/303
|
14.1%
21/149
|
|
Nervous system disorders
Dizziness
|
7.3%
22/303
|
8.7%
13/149
|
|
Nervous system disorders
Tremor
|
6.6%
20/303
|
6.7%
10/149
|
|
Nervous system disorders
Dysgeusia
|
5.9%
18/303
|
6.0%
9/149
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
31/303
|
13.4%
20/149
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
20/303
|
4.7%
7/149
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
16/303
|
5.4%
8/149
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
15/303
|
6.0%
9/149
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.3%
10/303
|
5.4%
8/149
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
26/303
|
5.4%
8/149
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
22/303
|
6.7%
10/149
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
13/303
|
8.1%
12/149
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
9/303
|
5.4%
8/149
|
|
Renal and urinary disorders
Acute kidney injury
|
9.9%
30/303
|
6.7%
10/149
|
|
Renal and urinary disorders
Pollakiuria
|
6.6%
20/303
|
6.7%
10/149
|
|
Renal and urinary disorders
Dysuria
|
5.6%
17/303
|
6.7%
10/149
|
|
Psychiatric disorders
Insomnia
|
10.2%
31/303
|
8.1%
12/149
|
|
Psychiatric disorders
Depression
|
6.6%
20/303
|
4.0%
6/149
|
|
Psychiatric disorders
Anxiety
|
4.6%
14/303
|
6.7%
10/149
|
|
Vascular disorders
Hypertension
|
10.9%
33/303
|
10.7%
16/149
|
|
Vascular disorders
Hypotension
|
10.6%
32/303
|
4.0%
6/149
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.3%
19/303
|
7.4%
11/149
|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
18/303
|
4.7%
7/149
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
16/303
|
5.4%
8/149
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
16/303
|
2.0%
3/149
|
|
Eye disorders
Dry eye
|
5.0%
15/303
|
7.4%
11/149
|
|
Cardiac disorders
Tachycardia
|
5.9%
18/303
|
2.7%
4/149
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Within 12 months after the end of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given opportunity to review and comment. Institution publications may be delayed up to an additional 60 days to allow Sponsor to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER