Trial Outcomes & Findings for The Medtronic TAVR 2.0 US Clinical Study (NCT NCT02738853)
NCT ID: NCT02738853
Last Updated: 2023-03-21
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
30 days
Results posted on
2023-03-21
Participant Flow
Participant milestones
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Enrollment
STARTED
|
93
|
|
Enrollment
COMPLETED
|
60
|
|
Enrollment
NOT COMPLETED
|
33
|
|
Procedure
STARTED
|
60
|
|
Procedure
COMPLETED
|
59
|
|
Procedure
NOT COMPLETED
|
1
|
|
1 Month
STARTED
|
59
|
|
1 Month
COMPLETED
|
57
|
|
1 Month
NOT COMPLETED
|
2
|
|
6 Month
STARTED
|
57
|
|
6 Month
COMPLETED
|
51
|
|
6 Month
NOT COMPLETED
|
6
|
|
1 Year
STARTED
|
51
|
|
1 Year
COMPLETED
|
44
|
|
1 Year
NOT COMPLETED
|
7
|
|
2 Year
STARTED
|
44
|
|
2 Year
COMPLETED
|
41
|
|
2 Year
NOT COMPLETED
|
3
|
|
3 Year
STARTED
|
41
|
|
3 Year
COMPLETED
|
38
|
|
3 Year
NOT COMPLETED
|
3
|
|
4 Year
STARTED
|
38
|
|
4 Year
COMPLETED
|
29
|
|
4 Year
NOT COMPLETED
|
9
|
|
5 Year
STARTED
|
29
|
|
5 Year
COMPLETED
|
25
|
|
5 Year
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Enrollment
Inclusion/Exclusion not met
|
21
|
|
Enrollment
Withdrawal by Subject
|
3
|
|
Enrollment
Subject treated with commercially available device
|
6
|
|
Enrollment
Study Enrollment Closed
|
3
|
|
Procedure
Death
|
1
|
|
1 Month
Death
|
2
|
|
6 Month
Death
|
4
|
|
6 Month
Withdrawal by Subject
|
2
|
|
1 Year
Death
|
6
|
|
1 Year
Withdrawal by Subject
|
1
|
|
2 Year
Death
|
2
|
|
2 Year
Lost to Follow-up
|
1
|
|
3 Year
Death
|
2
|
|
3 Year
Withdrawal by Subject
|
1
|
|
4 Year
Death
|
9
|
|
5 Year
Lost to Follow-up
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Age, Continuous
|
83.3 years
STANDARD_DEVIATION 7.2 • n=60 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
All-cause Mortality Rate
|
1.7 percentage of participants
Interval 0.2 to 11.2
|
PRIMARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Stroke (Disabling) Rate
|
1.7 percentage of participants
Interval 0.2 to 11.4
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Only subjects with transthoracic echo (TTE) could be analyzed.
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=58 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram
|
72.4 percentage of participants
Interval 59.1 to 83.3
|
SECONDARY outcome
Timeframe: 30 days1. All-cause mortality \> 2. All stroke (disabling and non-disabling) \> 3. Life-threatening bleeding \> 4. Acute kidney injury: stage 2 or 3 (including renal replacement therapy) \> 5. Coronary artery obstruction requiring intervention \> 6. Major vascular complication \> 7. Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:
|
15.0 percentage of participants
Interval 8.1 to 26.8
|
SECONDARY outcome
Timeframe: 30 daysPercentage of participants with life threatening or disabling bleeding - VARC-II definitions
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Percentage of Participants With Life Threatening or Disabling Bleeding
|
11.7 percentage of participants
Interval 5.7 to 22.9
|
SECONDARY outcome
Timeframe: 30 daysPercentage of participants with major vascular complication - VARC-II definition
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Percentage of Participants With Major Vascular Complication
|
10.0 percentage of participants
Interval 4.6 to 20.9
|
SECONDARY outcome
Timeframe: 30 daysPercentage of participants with coronary artery obstruction - VARC-II definitions
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Percentage of Participants With Coronary Artery Obstruction
|
0.0 percentage of participants
Interval 0.0 to 6.1
|
SECONDARY outcome
Timeframe: 30 daysPercentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Percentage of Patient With Acute Kidney Injury- Stage 2 or 3
|
1.7 percentage of participants
Interval 0.2 to 11.2
|
SECONDARY outcome
Timeframe: 30 daysPercentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure
|
0.0 percentage of participants
Interval 0.0 to 6.1
|
SECONDARY outcome
Timeframe: 24 hours to 7 daysOutcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Device Success Rate (VARC II)
|
80.8 percentage of participants
Interval 67.5 to 90.4
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Only subjects with TTE could be analyzed.
Aortic Valve Area (cm2) by transthoracic echocardiogram
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Hemodynamic Performance - Aortic Valve Area
|
2.0 cm2
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Only subjects with TTE could be analyzed.
Mean gradient (mmHg) by transthoracic echocardiogram
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=60 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Hemodynamic Performance - Mean Gradient
|
6.4 mmHg
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Only subjects with TTE could be analyzed.
Total prosthetic regurgitation by transthoracic echocardiogram
Outcome measures
| Measure |
Medtronic Transcatheter Aortic Valve 2.0 Replacement System
n=58 Participants
Treatment of Aortic Stenosis by replacing native valve with the Medtronic Transcatheter Aortic Valve 2.0 System
Medtronic Transcatheter Aortic Valve 2.0 Replacement System: Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
|
|---|---|
|
Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace
|
72.4 percentage of participants
|
Adverse Events
TAVR 2.0
Serious events: 39 serious events
Other events: 38 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
TAVR 2.0
n=60 participants at risk
Participants implanted with the TAVR 2.0 system
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.7%
7/60 • Number of events 8 • All events 6 months, All Cause Mortality 60 months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrial Fibrillation
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrioventricular Block Complete
|
13.3%
8/60 • Number of events 8 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Bradycardia
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Bundle Branch Block Left
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
5.0%
3/60 • Number of events 5 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Cardiac Perforation
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Cardiac Tamponade
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Pericardial Effusion
|
5.0%
3/60 • Number of events 3 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Sinus Bradycardia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
Asthenia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
Chest Pain
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
Device Embolisation
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
Implant Site Haemorrhage
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
General disorders
Pyrexia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Cellulitis
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Gastroenteritis
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Incision Site Cellulitis
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Pneumonia
|
5.0%
3/60 • Number of events 3 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Complication
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
5.0%
3/60 • Number of events 3 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Haemorrhage Intracranial
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Presyncope
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Seizure
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Syncope
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Psychiatric disorders
Confusional State
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Psychiatric disorders
Delirium
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Psychiatric disorders
Mental Disorder
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Renal and urinary disorders
Urinary Retention
|
5.0%
3/60 • Number of events 3 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Oedema
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Surgical and medical procedures
Skin Graft
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Aortic Dissection
|
1.7%
1/60 • Number of events 1 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Hypertension
|
3.3%
2/60 • Number of events 2 • All events 6 months, All Cause Mortality 60 months
|
|
Vascular disorders
Hypotension
|
5.0%
3/60 • Number of events 3 • All events 6 months, All Cause Mortality 60 months
|
Other adverse events
| Measure |
TAVR 2.0
n=60 participants at risk
Participants implanted with the TAVR 2.0 system
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
6/60 • Number of events 6 • All events 6 months, All Cause Mortality 60 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.7%
4/60 • Number of events 4 • All events 6 months, All Cause Mortality 60 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
10/60 • Number of events 10 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrial Fibrillation
|
10.0%
6/60 • Number of events 6 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
13.3%
8/60 • Number of events 8 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Bundle Branch Block Left
|
35.0%
21/60 • Number of events 24 • All events 6 months, All Cause Mortality 60 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
8.3%
5/60 • Number of events 5 • All events 6 months, All Cause Mortality 60 months
|
|
Infections and infestations
Urinary Tract Infection
|
8.3%
5/60 • Number of events 5 • All events 6 months, All Cause Mortality 60 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.3%
5/60 • Number of events 5 • All events 6 months, All Cause Mortality 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.0%
6/60 • Number of events 6 • All events 6 months, All Cause Mortality 60 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place