Trial Outcomes & Findings for Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (NCT NCT03281538)
NCT ID: NCT03281538
Last Updated: 2021-10-14
Results Overview
Assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
288 participants
Primary outcome timeframe
Up to 52 weeks
Results posted on
2021-10-14
Participant Flow
Participant milestones
| Measure |
CR845 0.5mcg/kg
CR845 0.5mcg/kg IV medication administered three times/week after dialysis
CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
|
|---|---|
|
Overall Study
STARTED
|
288
|
|
Overall Study
COMPLETED
|
133
|
|
Overall Study
NOT COMPLETED
|
155
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Baseline characteristics by cohort
| Measure |
CR845 0.5mcg/kg
n=288 Participants
CR845 0.5mcg/kg IV medication administered three times/week after dialysis
CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
|
|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 12.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
148 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksAssessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments
Outcome measures
| Measure |
CR845 0.5mcg/kg
n=288 Participants
CR845 0.5mcg/kg IV medication administered three times/week after dialysis
CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
|
|---|---|
|
Number of Participants With AEs
|
240 Participants
|
Adverse Events
CR845 0.5mcg/kg
Serious events: 148 serious events
Other events: 139 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
CR845 0.5mcg/kg
n=288 participants at risk
CR845 0.5mcg/kg IV medication administered three times/week after dialysis
CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.0%
3/288 • Up to 52 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.69%
2/288 • Up to 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
4.9%
14/288 • Up to 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
2.8%
8/288 • Up to 52 weeks
|
|
Cardiac disorders
Cardiac arrest
|
2.8%
8/288 • Up to 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
2.8%
8/288 • Up to 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
4/288 • Up to 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
1.0%
3/288 • Up to 52 weeks
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
3/288 • Up to 52 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
0.69%
2/288 • Up to 52 weeks
|
|
Cardiac disorders
Acute left ventricular failure
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Bradycardia
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Cardiac tamponade
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Cardiogenic shock
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Left ventricular failure
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Myocardia ischaemia
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Pericarditis
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Tachycardia
|
0.35%
1/288 • Up to 52 weeks
|
|
Eye disorders
Diplopia
|
0.35%
1/288 • Up to 52 weeks
|
|
Eye disorders
Visual impairment
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.1%
6/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.69%
2/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.69%
2/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.69%
2/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.69%
2/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.69%
2/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Discoloured vomit
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Haematemesis
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Proctitis
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.35%
1/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.35%
1/288 • Up to 52 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.8%
8/288 • Up to 52 weeks
|
|
General disorders
Asthenia
|
1.4%
4/288 • Up to 52 weeks
|
|
General disorders
Death
|
0.69%
2/288 • Up to 52 weeks
|
|
General disorders
Impaired healing
|
0.69%
2/288 • Up to 52 weeks
|
|
General disorders
Catheter site thrombosis
|
0.35%
1/288 • Up to 52 weeks
|
|
General disorders
Chest pain
|
0.35%
1/288 • Up to 52 weeks
|
|
General disorders
Complication associated with device
|
0.35%
1/288 • Up to 52 weeks
|
|
General disorders
Drug interaction
|
0.35%
1/288 • Up to 52 weeks
|
|
General disorders
Sudden death
|
0.35%
1/288 • Up to 52 weeks
|
|
General disorders
Vascular stent restenosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.35%
1/288 • Up to 52 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.35%
1/288 • Up to 52 weeks
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Pneumonia
|
4.2%
12/288 • Up to 52 weeks
|
|
Infections and infestations
Sepsis
|
3.1%
9/288 • Up to 52 weeks
|
|
Infections and infestations
Bacteraemia
|
2.1%
6/288 • Up to 52 weeks
|
|
Infections and infestations
Cellulitis
|
2.1%
6/288 • Up to 52 weeks
|
|
Infections and infestations
Osteomyelitis
|
1.7%
5/288 • Up to 52 weeks
|
|
Infections and infestations
Clostridium difficile colitis
|
1.0%
3/288 • Up to 52 weeks
|
|
Infections and infestations
Gangrene
|
1.0%
3/288 • Up to 52 weeks
|
|
Infections and infestations
Septic shock
|
1.0%
3/288 • Up to 52 weeks
|
|
Infections and infestations
Infected skin ulcer
|
0.69%
2/288 • Up to 52 weeks
|
|
Infections and infestations
Staphylococcal sepsis
|
0.69%
2/288 • Up to 52 weeks
|
|
Infections and infestations
Abscess limb
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Appendicitis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Ateriovenous fistula site infection
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Ateriovenous graft site abscess
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Bronchitis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Bronchitis viral
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Cardiac valve vegetation
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Catheter site infection
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Device related sepsis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Diverticulitis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Influenza
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Klebsiella sepsis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Latent tuberculosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Otitis externa
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Perirectal abscess
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Serratia sepsis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Subacute endocarditis
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.35%
1/288 • Up to 52 weeks
|
|
Infections and infestations
Vascular access site infection
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.7%
5/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
3/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Vascular access malfunction
|
1.0%
3/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Vascular access site thrombosis
|
0.69%
2/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.69%
2/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Chemical burn of respiratory tract
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.35%
1/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.35%
1/288 • Up to 52 weeks
|
|
Investigations
Blood pressure increased
|
0.35%
1/288 • Up to 52 weeks
|
|
Investigations
Cardiac stress test abnormal
|
0.35%
1/288 • Up to 52 weeks
|
|
Investigations
Electrocardiogram T wave inversion
|
0.35%
1/288 • Up to 52 weeks
|
|
Metabolism and nutrition disorders
Fluid overload
|
5.9%
17/288 • Up to 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.2%
15/288 • Up to 52 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.0%
3/288 • Up to 52 weeks
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.69%
2/288 • Up to 52 weeks
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.35%
1/288 • Up to 52 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.35%
1/288 • Up to 52 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.35%
1/288 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.35%
1/288 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.35%
1/288 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.35%
1/288 • Up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bening lung neoplasm
|
0.35%
1/288 • Up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Syncope
|
2.4%
7/288 • Up to 52 weeks
|
|
Nervous system disorders
Dizziness
|
1.0%
3/288 • Up to 52 weeks
|
|
Nervous system disorders
Brain stem infarction
|
0.69%
2/288 • Up to 52 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.69%
2/288 • Up to 52 weeks
|
|
Nervous system disorders
Seizure
|
0.69%
2/288 • Up to 52 weeks
|
|
Nervous system disorders
Brain injury
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Encephalopathy
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Lethargy
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Neurological symptom
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Presyncope
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Status epilepticus
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.35%
1/288 • Up to 52 weeks
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.35%
1/288 • Up to 52 weeks
|
|
Product Issues
Device expulsion
|
0.35%
1/288 • Up to 52 weeks
|
|
Psychiatric disorders
Mental status changes
|
2.8%
8/288 • Up to 52 weeks
|
|
Psychiatric disorders
Anxiety
|
0.69%
2/288 • Up to 52 weeks
|
|
Psychiatric disorders
Confusional state
|
0.35%
1/288 • Up to 52 weeks
|
|
Psychiatric disorders
Hallucination, visual
|
0.35%
1/288 • Up to 52 weeks
|
|
Psychiatric disorders
Major depression
|
0.35%
1/288 • Up to 52 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.35%
1/288 • Up to 52 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.35%
1/288 • Up to 52 weeks
|
|
Reproductive system and breast disorders
Genital lesion
|
0.35%
1/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
8/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.1%
6/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
4/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
4/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
3/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.69%
2/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.69%
2/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.35%
1/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.35%
1/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia apsiration
|
0.35%
1/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.35%
1/288 • Up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.69%
2/288 • Up to 52 weeks
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.35%
1/288 • Up to 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Hypotension
|
3.1%
9/288 • Up to 52 weeks
|
|
Vascular disorders
Hypertensive emergency
|
1.0%
3/288 • Up to 52 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.69%
2/288 • Up to 52 weeks
|
|
Vascular disorders
Shock haemorrhagic
|
0.69%
2/288 • Up to 52 weeks
|
|
Vascular disorders
Steal syndrome
|
0.69%
2/288 • Up to 52 weeks
|
|
Vascular disorders
Accelerated hypertension
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Aortic stenosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Arterial stenosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Hypertension
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Jugular vein thrombosis
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Peripheral artery occlusion
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.35%
1/288 • Up to 52 weeks
|
|
Vascular disorders
Peripheral venous disease
|
0.35%
1/288 • Up to 52 weeks
|
|
Cardiac disorders
Pericardial effusion
|
0.69%
2/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.35%
1/288 • Up to 52 weeks
|
Other adverse events
| Measure |
CR845 0.5mcg/kg
n=288 participants at risk
CR845 0.5mcg/kg IV medication administered three times/week after dialysis
CR845: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
48/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
15.3%
44/288 • Up to 52 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
14.6%
42/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
38/288 • Up to 52 weeks
|
|
Vascular disorders
Hypotension
|
10.4%
30/288 • Up to 52 weeks
|
|
General disorders
Non-cardiac chest pain
|
7.6%
22/288 • Up to 52 weeks
|
|
Nervous system disorders
Dizziness
|
7.3%
21/288 • Up to 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
18/288 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
16/288 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
15/288 • Up to 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place