Trial Outcomes & Findings for Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia (NCT NCT00772382)
NCT ID: NCT00772382
Last Updated: 2026-01-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
116 participants
Primary outcome timeframe
52 weeks
Results posted on
2026-01-08
Participant Flow
Participant milestones
| Measure |
MCI-196
3, 6, 9, 12, or 15 g/ day as titrated
|
|---|---|
|
Overall Study
STARTED
|
116
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
MCI-196
3, 6, 9, 12, or 15 g/ day as titrated
|
|---|---|
|
Overall Study
Adverse Event
|
19
|
|
Overall Study
Death
|
6
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Other Reasons
|
10
|
Baseline Characteristics
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Baseline characteristics by cohort
| Measure |
MCI-196
n=116 Participants
3, 6, 9, 12, or 15 g/ day as titrated
|
|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 13.8 • n=18 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 52 weeksOutcome measures
| Measure |
MCI-196
n=116 Participants
3, 6, 9, 12, or 15 g/ day as titrated
|
|---|---|
|
Number of Adverse Events (AE)
At least 1 treatment-emergent serious AE
|
63 participants
|
|
Number of Adverse Events (AE)
At least 1 treatment-emergent AE
|
109 participants
|
|
Number of Adverse Events (AE)
At least 1 drug-related treatment-emergent AE
|
50 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intent-to-treat (ITT) with last observation carried forward (LOCF). (ITT population included all enrolled subjects who took at least one dose of study medication and had at least one post-enrollment efficacy value after the start of study medication.)
Outcome measures
| Measure |
MCI-196
n=116 Participants
3, 6, 9, 12, or 15 g/ day as titrated
|
|---|---|
|
The Change in Serum Phosphorus From Baseline to Week 52
|
-1.18 mg/dL
95% Confidence Interval 2.05 • Interval -1.56 to -0.81
|
Adverse Events
MCI-196
Serious events: 63 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCI-196
n=116 participants at risk
3, 6, 9, 12, or 15 g/ day as titrated
|
|---|---|
|
Vascular disorders
Hypertensive crisis
|
2.6%
3/116 • 52 weeks
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Haemorrhage
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Jugular vein thrombosis
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Malignant hypertension
|
1.7%
2/116 • 52 weeks
|
|
Vascular disorders
Superior vena caval occlusion
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Vena cava thrombosis
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Accelerated hypertension
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Venous stenosis
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Peripheral vascular disorder
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
2/116 • 52 weeks
|
|
Vascular disorders
Hypotension
|
1.7%
2/116 • 52 weeks
|
|
Vascular disorders
Steal syndrome
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Pyrexia
|
2.6%
3/116 • 52 weeks
|
|
General disorders
Catheter related complication
|
2.6%
3/116 • 52 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.6%
3/116 • 52 weeks
|
|
General disorders
Chest pain
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/116 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Bacteraemia
|
1.7%
2/116 • 52 weeks
|
|
Infections and infestations
Pharyngeal abscess
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Diabetic foot infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
6.0%
7/116 • 52 weeks
|
|
Infections and infestations
Sepsis
|
5.2%
6/116 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.7%
2/116 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.3%
5/116 • 52 weeks
|
|
Infections and infestations
Wound infection staphylococcal
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Wound infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Gangrene
|
2.6%
3/116 • 52 weeks
|
|
Infections and infestations
Peritonitis bacterial
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
2.6%
3/116 • 52 weeks
|
|
Infections and infestations
Bacterial sepsis
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Helicobacter gastritis
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
6.0%
7/116 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
2.6%
3/116 • 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
7.8%
9/116 • 52 weeks
|
|
Cardiac disorders
Cardiac discomfort
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
2/116 • 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
5/116 • 52 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Angina unstable
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Cardiomyopathy
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
3/116 • 52 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
4.3%
5/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.2%
6/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
1.7%
2/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.7%
2/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
3/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
5/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.6%
3/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
2/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.7%
2/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Lupus nephritis
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Azotaemia
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Hydronephrosis
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
2.6%
3/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Ammonia increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
International normalised ratio increased
|
0.86%
1/116 • 52 weeks
|
|
Psychiatric disorders
Mental status changes
|
0.86%
1/116 • 52 weeks
|
|
Psychiatric disorders
Drug abuse
|
0.86%
1/116 • 52 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
3/116 • 52 weeks
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.86%
1/116 • 52 weeks
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.7%
2/116 • 52 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Lacunar infarction
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Partial seizures
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
2.6%
3/116 • 52 weeks
|
|
Nervous system disorders
Carotid artery stenosis
|
1.7%
2/116 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.86%
1/116 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.86%
1/116 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.86%
1/116 • 52 weeks
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.86%
1/116 • 52 weeks
|
Other adverse events
| Measure |
MCI-196
n=116 participants at risk
3, 6, 9, 12, or 15 g/ day as titrated
|
|---|---|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.6%
3/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
1.7%
2/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
3.4%
4/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
2.6%
3/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.7%
2/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.7%
2/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
11/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.2%
13/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
4/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.7%
2/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.7%
2/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.7%
2/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
1.7%
2/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.6%
3/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.7%
2/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
3/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.6%
3/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural rub
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
1.7%
2/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.86%
1/116 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.86%
1/116 • 52 weeks
|
|
Psychiatric disorders
Delirium
|
0.86%
1/116 • 52 weeks
|
|
Psychiatric disorders
Confusional state
|
2.6%
3/116 • 52 weeks
|
|
Psychiatric disorders
Insomnia
|
7.8%
9/116 • 52 weeks
|
|
Psychiatric disorders
Stress
|
0.86%
1/116 • 52 weeks
|
|
Psychiatric disorders
Anxiety
|
3.4%
4/116 • 52 weeks
|
|
Psychiatric disorders
Drug abuse
|
0.86%
1/116 • 52 weeks
|
|
Psychiatric disorders
Depression
|
1.7%
2/116 • 52 weeks
|
|
Infections and infestations
Herpes zoster
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Clostridial infection
|
2.6%
3/116 • 52 weeks
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.9%
8/116 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
1.7%
2/116 • 52 weeks
|
|
Infections and infestations
Gangrene
|
1.7%
2/116 • 52 weeks
|
|
Infections and infestations
Localised infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Nail infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.6%
3/116 • 52 weeks
|
|
Infections and infestations
Bronchitis
|
5.2%
6/116 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
11/116 • 52 weeks
|
|
Infections and infestations
Sinusitis
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Enterococcal infection
|
1.7%
2/116 • 52 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
9/116 • 52 weeks
|
|
Infections and infestations
Bacterial disease carrier
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Arteriovenous fistula site infection
|
2.6%
3/116 • 52 weeks
|
|
Infections and infestations
Tooth abscess
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
1.7%
2/116 • 52 weeks
|
|
Infections and infestations
Furuncle
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Peritonitis bacterial
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Ear infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Hepatitis C
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Onychomycosis
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Catheter related infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Catheter site infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Pleural infection bacterial
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Staphylococcal infection
|
1.7%
2/116 • 52 weeks
|
|
Infections and infestations
Graft infection
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Wound infection staphylococcal
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Oral candidiasis
|
0.86%
1/116 • 52 weeks
|
|
Infections and infestations
Oesophageal candidiasis
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
7/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.7%
2/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
8/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.6%
3/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.4%
4/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.2%
6/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
3/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.86%
1/116 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Hemiparesis
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
3/116 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
7.8%
9/116 • 52 weeks
|
|
Nervous system disorders
Headache
|
9.5%
11/116 • 52 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Facial palsy
|
1.7%
2/116 • 52 weeks
|
|
Nervous system disorders
Syncope
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Dementia
|
1.7%
2/116 • 52 weeks
|
|
Nervous system disorders
Somnolence
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Altered state of consciousness
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Presyncope
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Tremor
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Aphasia
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Restless legs syndrome
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Carotid artery occlusion
|
0.86%
1/116 • 52 weeks
|
|
Nervous system disorders
Carotid artery stenosis
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Pyrexia
|
7.8%
9/116 • 52 weeks
|
|
General disorders
Chest discomfort
|
2.6%
3/116 • 52 weeks
|
|
General disorders
Asthenia
|
1.7%
2/116 • 52 weeks
|
|
General disorders
Malaise
|
3.4%
4/116 • 52 weeks
|
|
General disorders
Oedema peripheral
|
6.9%
8/116 • 52 weeks
|
|
General disorders
Chest pain
|
3.4%
4/116 • 52 weeks
|
|
General disorders
Feeling hot
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Non-cardiac chest pain
|
1.7%
2/116 • 52 weeks
|
|
General disorders
Feeling cold
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Face oedema
|
2.6%
3/116 • 52 weeks
|
|
General disorders
Fatigue
|
1.7%
2/116 • 52 weeks
|
|
General disorders
Local swelling
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Localised oedema
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Chills
|
3.4%
4/116 • 52 weeks
|
|
General disorders
Pain
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Influenza like illness
|
1.7%
2/116 • 52 weeks
|
|
General disorders
Gait disturbance
|
1.7%
2/116 • 52 weeks
|
|
General disorders
Catheter related complication
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Vessel puncture site haemorrhage
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Inflammation
|
0.86%
1/116 • 52 weeks
|
|
General disorders
Catheter site pain
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Breath sounds abnormal
|
2.6%
3/116 • 52 weeks
|
|
Investigations
Blood cholesterol increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Blood parathyroid hormone increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Methicillin-resistant staphylococcal aureus test positive
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Blood glucose increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Blood phosphorus increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Venous pressure increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Ammonia increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Gram stain positive
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Weight decreased
|
1.7%
2/116 • 52 weeks
|
|
Investigations
Vitamin D decreased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Liver function test abnormal
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Cardiac murmur
|
1.7%
2/116 • 52 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
1.7%
2/116 • 52 weeks
|
|
Investigations
Chest X-ray abnormal
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Cardiovascular function test abnormal
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Activated partial thromboplastin time abnormal
|
0.86%
1/116 • 52 weeks
|
|
Investigations
International normalised ratio abnormal
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Prothrombin time abnormal
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Prostatic specific antigen increased
|
0.86%
1/116 • 52 weeks
|
|
Investigations
Blood glucose decreased
|
1.7%
2/116 • 52 weeks
|
|
Investigations
Blood culture positive
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.1%
14/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.3%
5/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.0%
7/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.0%
7/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.4%
4/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperhomocysteinaemia
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.6%
3/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.7%
2/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Folate deficiency
|
1.7%
2/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.86%
1/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.7%
2/116 • 52 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.3%
5/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
5/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
1.7%
2/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.7%
2/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
3/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.86%
1/116 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Azotaemia
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Polyuria
|
0.86%
1/116 • 52 weeks
|
|
Renal and urinary disorders
Renal failure chronic
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
4/116 • 52 weeks
|
|
Cardiac disorders
Bradycardia
|
1.7%
2/116 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
4.3%
5/116 • 52 weeks
|
|
Cardiac disorders
Diastolic dysfunction
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Coronary artery occlusion
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Tachycardia
|
1.7%
2/116 • 52 weeks
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Conduction disorder
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Bundle branch block left
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Cardiac tamponade
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Cardiomyopathy
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Cardiomegaly
|
1.7%
2/116 • 52 weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Tachyarrhythmia
|
0.86%
1/116 • 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Hypotension
|
8.6%
10/116 • 52 weeks
|
|
Vascular disorders
Hypertension
|
7.8%
9/116 • 52 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
1.7%
2/116 • 52 weeks
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Air embolism
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Haematoma
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Jugular vein distension
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Vasodilatation
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Venous occlusion
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Arterial thrombosis limb
|
0.86%
1/116 • 52 weeks
|
|
Vascular disorders
Aortic dilatation
|
0.86%
1/116 • 52 weeks
|
|
Eye disorders
Scleral haemorrhage
|
0.86%
1/116 • 52 weeks
|
|
Eye disorders
Eye swelling
|
0.86%
1/116 • 52 weeks
|
|
Eye disorders
Ocular hyperaemia
|
0.86%
1/116 • 52 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
0.86%
1/116 • 52 weeks
|
|
Eye disorders
Conjunctivitis
|
0.86%
1/116 • 52 weeks
|
|
Eye disorders
Cataract
|
0.86%
1/116 • 52 weeks
|
|
Eye disorders
Eye irritation
|
0.86%
1/116 • 52 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
8/116 • 52 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
2/116 • 52 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.86%
1/116 • 52 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.7%
2/116 • 52 weeks
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.86%
1/116 • 52 weeks
|
|
Endocrine disorders
Hypothyroidism
|
1.7%
2/116 • 52 weeks
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
1.7%
2/116 • 52 weeks
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.86%
1/116 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.86%
1/116 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.86%
1/116 • 52 weeks
|
|
Immune system disorders
Seasonal allergy
|
1.7%
2/116 • 52 weeks
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.86%
1/116 • 52 weeks
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.86%
1/116 • 52 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.7%
2/116 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.0%
7/116 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Ascites
|
4.3%
5/116 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
19.8%
23/116 • 52 weeks
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
2/116 • 52 weeks
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
20.7%
24/116 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
22.4%
26/116 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
5/116 • 52 weeks
|
|
Gastrointestinal disorders
Oesophagitis
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.7%
2/116 • 52 weeks
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
9.5%
11/116 • 52 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
10/116 • 52 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
1.7%
2/116 • 52 weeks
|
|
Gastrointestinal disorders
Faecaloma
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Ileus
|
1.7%
2/116 • 52 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Toothache
|
1.7%
2/116 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Glossodynia
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.7%
2/116 • 52 weeks
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Colonic polyp
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
2/116 • 52 weeks
|
|
Gastrointestinal disorders
Melaena
|
0.86%
1/116 • 52 weeks
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
2/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
3/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Haemodialysis-induced symptom
|
11.2%
13/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
9.5%
11/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.7%
2/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.6%
3/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.86%
1/116 • 52 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
0.86%
1/116 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER