Trial Outcomes & Findings for Zenith® Dissection Clinical Trial (NCT NCT01568320)
NCT ID: NCT01568320
Last Updated: 2021-03-16
Results Overview
Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
30 days
Results posted on
2021-03-16
Participant Flow
Participant milestones
| Measure |
Endovascular
Endovascular Treatment (Zenith)
Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Overall Study
STARTED
|
73
|
|
Overall Study
5-Year
|
36
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Endovascular
Endovascular Treatment (Zenith)
Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Overall Study
Death
|
20
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
Conversion to open repair
|
1
|
|
Overall Study
Patient fell outside of the consented window, data outside of the consented 5-year was not collected
|
1
|
Baseline Characteristics
Zenith® Dissection Clinical Trial
Baseline characteristics by cohort
| Measure |
Endovascular
n=73 Participants
Endovascular Treatment (Zenith)
Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment).Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1
Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support
Outcome measures
| Measure |
Endovascular
n=67 Participants
Endovascular Treatment (Zenith)
Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Number of Participants With Freedom From Major Adverse Events
|
48 participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment). Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1
Primary effectiveness endpoint is freedom from all cause mortality at 30 days
Outcome measures
| Measure |
Endovascular
n=67 Participants
Endovascular Treatment (Zenith)
Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Survival Rate at 30 Days
|
64 participants
|
Adverse Events
Endovascular
Serious events: 63 serious events
Other events: 40 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Endovascular
n=73 participants at risk
Endovascular Treatment (Zenith)
Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Cardiac disorders
Angina pectoris
|
5.5%
4/73 • Number of events 4 • 5-Year
|
|
Cardiac disorders
Arrhythmia
|
5.5%
4/73 • Number of events 4 • 5-Year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Cardiac disorders
Cardiac tamponade
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Cardiac disorders
Coronary artery stenosis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Cardiac disorders
Mitral valve prolapse
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Cardiac disorders
Myocardial infarction
|
4.1%
3/73 • Number of events 3 • 5-Year
|
|
Cardiac disorders
Myocardial ischaemia
|
4.1%
3/73 • Number of events 3 • 5-Year
|
|
Eye disorders
Cataract
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Gastoroesophageal reflux disease
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Gastric volvulus
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Gastrointestinal disorders
Haematemesis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Hiatus hernia
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Ileus paralytic
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
4.1%
3/73 • Number of events 3 • 5-Year
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Large intestine ulcer
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Melaena
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Mouth swelling
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/73 • Number of events 2 • 5-Year
|
|
Gastrointestinal disorders
Oesophageal perforation
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/73 • Number of events 2 • 5-Year
|
|
General disorders
Asthenia
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
General disorders
Chest discomfort
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
General disorders
Chest pain
|
6.8%
5/73 • Number of events 5 • 5-Year
|
|
General disorders
Mucosal inflammation
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
General disorders
Multiple organ dysfunction syndrome
|
4.1%
3/73 • Number of events 3 • 5-Year
|
|
General disorders
Nodule
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
General disorders
Non-cardiac chest pain
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
General disorders
Pyrexia
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
General disorders
Stent-graft endoleak
|
4.1%
3/73 • Number of events 4 • 5-Year
|
|
General disorders
Swelling
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Infections and infestations
Appendicitis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Infections and infestations
Bacillus infection
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Infections and infestations
Bronchitis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Infections and infestations
Cellulitis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Infections and infestations
Gastrointestinal infection
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Infections and infestations
Helicobacter infection
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Infections and infestations
Influenza
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Infections and infestations
Pneumonia
|
5.5%
4/73 • Number of events 5 • 5-Year
|
|
Infections and infestations
Sepsis
|
2.7%
2/73 • Number of events 3 • 5-Year
|
|
Infections and infestations
Urinary tract infection
|
4.1%
3/73 • Number of events 3 • 5-Year
|
|
Infections and infestations
Vascular access site infection
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Infections and infestations
Vascular device infection
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Device use error
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Seroma
|
1.4%
1/73 • Number of events 2 • 5-Year
|
|
Injury, poisoning and procedural complications
Skull fracture
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.7%
2/73 • Number of events 3 • 5-Year
|
|
Investigations
Blood creatinine increased
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Investigations
White blood cell count increased
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Arthraglia
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
6/73 • Number of events 6 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma metastatic
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Cerebrovascular accident
|
8.2%
6/73 • Number of events 6 • 5-Year
|
|
Nervous system disorders
Dizziness
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Headache
|
1.4%
1/73 • Number of events 2 • 5-Year
|
|
Nervous system disorders
Lethargy
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Motor dysfunction
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Nervous system disorder
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Paraparesis
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Nervous system disorders
Paraplegia
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Nervous system disorders
Seizure
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Syncope
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Nervous system disorders
Transient ischaemic attack
|
4.1%
3/73 • Number of events 4 • 5-Year
|
|
Product Issues
Device lead damage
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Product Issues
Stent malfunction
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Psychiatric disorders
Delirium
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Psychiatric disorders
Mental status changes
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Renal and urinary disorders
Acute kidney injury
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Renal and urinary disorders
Haematuria
|
2.7%
2/73 • Number of events 3 • 5-Year
|
|
Renal and urinary disorders
Renal failure
|
9.6%
7/73 • Number of events 8 • 5-Year
|
|
Renal and urinary disorders
Renal tubular necrosis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.5%
4/73 • Number of events 4 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.8%
5/73 • Number of events 5 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.2%
6/73 • Number of events 6 • 5-Year
|
|
Surgical and medical procedures
Enterostomy
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Surgical and medical procedures
Intervertebral disc operation
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Surgical and medical procedures
Mechanical ventilation
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Vascular disorders
Aortic aneurysm
|
8.2%
6/73 • Number of events 6 • 5-Year
|
|
Vascular disorders
Aortic dissection
|
8.2%
6/73 • Number of events 8 • 5-Year
|
|
Vascular disorders
Aortic rupture
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Vascular disorders
Arterial thrombosis
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Vascular disorders
Haematoma
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Vascular disorders
Hypertension
|
4.1%
3/73 • Number of events 3 • 5-Year
|
|
Vascular disorders
Hypertensive urgency
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Vascular disorders
Hypotension
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Vascular disorders
Iliac artery dissection
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Vascular disorders
Iliac artery occlusion
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Vascular disorders
Iliac artery stenosis
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Vascular disorders
Intermittent claudication
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Vascular disorders
Malignant hypertension
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Vascular disorders
Peripheral ischaemia
|
2.7%
2/73 • Number of events 2 • 5-Year
|
|
Vascular disorders
Subclavian steal syndrome
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Vascular disorders
Thrombus
|
1.4%
1/73 • Number of events 1 • 5-Year
|
|
Vascular disorders
Vascular dissection
|
1.4%
1/73 • Number of events 1 • 5-Year
|
Other adverse events
| Measure |
Endovascular
n=73 participants at risk
Endovascular Treatment (Zenith)
Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.3%
9/73 • Number of events 10 • 5-Year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.8%
5/73 • Number of events 5 • 5-Year
|
|
Cardiac disorders
Arrhythmia
|
11.0%
8/73 • Number of events 11 • 5-Year
|
|
General disorders
Chest pain
|
8.2%
6/73 • Number of events 8 • 5-Year
|
|
Infections and infestations
Urinary tract infection
|
15.1%
11/73 • Number of events 14 • 5-Year
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
6.8%
5/73 • Number of events 5 • 5-Year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.0%
8/73 • Number of events 9 • 5-Year
|
|
Nervous system disorders
Headache
|
5.5%
4/73 • Number of events 5 • 5-Year
|
|
Renal and urinary disorders
Urinary retention
|
9.6%
7/73 • Number of events 7 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.5%
4/73 • Number of events 4 • 5-Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.7%
10/73 • Number of events 10 • 5-Year
|
|
Vascular disorders
Hypertension
|
11.0%
8/73 • Number of events 8 • 5-Year
|
Additional Information
Alan Saunders, MS, RAC; Manager, Biostatistics
Cook Research Incorporated
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60