Trial Outcomes & Findings for Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent (NCT NCT00506493)
NCT ID: NCT00506493
Last Updated: 2023-11-29
Results Overview
Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
9 months
Results posted on
2023-11-29
Participant Flow
A total of 90 subjects were consented into the study, of which 75 subjects received study treatment at 13 of the 15 investigational centers in the United States. The first subject was enrolled on September 18, 2007 and last patient enrolled on October 27, 2010.
No additional wash out, run-in, or transition was utilized during this study. A subject was considered enrolled once treatment occurred.
Participant milestones
| Measure |
Cardioblate Surgical Ablation System
75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Cardioblate Surgical Ablation System
75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent
Baseline characteristics by cohort
| Measure |
Study Completion Cohort
n=75 Participants
75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
57 Participants
n=5 Participants
|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: 75 subjects were enrolled, 14 subjects had no Holter assessment performed- 6 subjects died, 5 subjects withdrew participation, and 3 subjects completed endpoint follow-up without analyzable Holter data.
Subject's cardiac rhythm was assessed by wearing a Holter Monitor for 24 hours
Outcome measures
| Measure |
Cardioblate Surgical Ablation System
n=61 Participants
All subjects enrolled who underwent surgical ablation with the Cardioblate Surgical Ablation system and completed a Holter assessment at 9 month follow-up
|
|---|---|
|
Efficacy Endpoint: The Percent of Patients Off Class I or III Antiarrhythmic Drugs and Out of AF as Determined by 24 Hour Holter Recording at 9 Months
|
42.6 percentage of subjects
|
PRIMARY outcome
Timeframe: 30 days post procedure or hospital dischargeMajor Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.
Outcome measures
| Measure |
Cardioblate Surgical Ablation System
n=75 Participants
All subjects enrolled who underwent surgical ablation with the Cardioblate Surgical Ablation system and completed a Holter assessment at 9 month follow-up
|
|---|---|
|
Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
|
6.7 percentage of subjects
Interval 0.0 to
|
SECONDARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
Cardioblate Surgical Ablation System
n=61 Participants
All subjects enrolled who underwent surgical ablation with the Cardioblate Surgical Ablation system and completed a Holter assessment at 9 month follow-up
|
|---|---|
|
Efficacy Endpoints: The Percent of Patients Out of AF, Regardless of Antiarrhythmic Drug Status, as Determined by a 24 Hour Holter Recording at 9 Months
|
67.2 percentage of subjects
|
SECONDARY outcome
Timeframe: 9 monthsMajor Adverse Events were defined to include: mediastinitis, death, myocardial infarction, stroke, transient ischemic attacks (TIA), pulmonary embolism, peripheral arterial embolism, and esophageal injury.
Outcome measures
| Measure |
Cardioblate Surgical Ablation System
n=70 Participants
All subjects enrolled who underwent surgical ablation with the Cardioblate Surgical Ablation system and completed a Holter assessment at 9 month follow-up
|
|---|---|
|
Safety Endpoints: Composite 9-month Major Adverse Event Rate, Post-procedure
|
11.4 percentage of subjects
|
Adverse Events
Study Completion Cohort
Serious events: 45 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Completion Cohort
n=75 participants at risk
75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
|
|---|---|
|
Infections and infestations
Endocarditis
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
GI Bleed
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Hemodynamic Instability
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Blood and lymphatic system disorders
Hemorrhage
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Hemothorax
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Infections and infestations
Infection/Sepsis
|
6.7%
5/75 • Number of events 5 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Pericardial Effusion
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
26.7%
20/75 • Number of events 21 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Atrioventricular Third Degree AV Heart Block
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Insufficiency/Failure
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Renal and urinary disorders
Renal Insufficiency/Failure: Dialysis Required
|
6.7%
5/75 • Number of events 5 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Renal and urinary disorders
Renal Insufficiency/Failure: No Dialysis Required
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress Syndrome
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Rhythms with Potentially Deleterious Hemodynamic Consequences Requiring Intervention
|
6.7%
5/75 • Number of events 7 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Shock
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Sick Sinus Syndrome
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Cardiac Tamponade
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Congestive Heart Failure
|
10.7%
8/75 • Number of events 8 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Angina Presenting as SOB
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Hepatobiliary disorders
Ascites with Paracentesis
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Atrial Fibrillation/Atrial Flutter/Bradycardia
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Atrial tachycardia with dyspnea on exertion
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
Chest tube site wound
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Nervous system disorders
Encephalopathy
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
General disorders
Flu
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Herniated lumbar disc
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Endocrine disorders
Liver Failure
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Endocrine disorders
Liver Shock
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Pain/discomfort on pacer site, right subclavian area
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Renal and urinary disorders
Rectal Bleeding
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Musculoskeletal and connective tissue disorders
Sternal Dehiscence
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Skin and subcutaneous tissue disorders
Upper Extremity Cellulitis
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
Other adverse events
| Measure |
Study Completion Cohort
n=75 participants at risk
75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
6/75 • Number of events 6 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Cardiac disorders
Hemodynamic Instability
|
9.3%
7/75 • Number of events 7 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
20.0%
15/75 • Number of events 15 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
22.7%
17/75 • Number of events 17 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
6.7%
5/75 • Number of events 5 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
|
Renal and urinary disorders
Renal Insufficiency/Failure: No Dialysis Required
|
12.0%
9/75 • Number of events 9 • Adverse events reported from treatment through 9 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB reviewed the data and made recommendations regarding any safety concerns and also assessed the data from a risk/benefit perspective. The CEC reviewed and adjudicated MAEs and serious adverse events (SAEs).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60