Trial Outcomes & Findings for Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study (NCT NCT00431834)
NCT ID: NCT00431834
Last Updated: 2013-11-27
Results Overview
Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
6 months
Results posted on
2013-11-27
Participant Flow
A total of 91 subjects were consented to the study, of which 75 subjects received study treatment at 14 of the 15 investigational centers in the United States. The first subject was enrolled on May 22, 2007 and last patient enrolled on February 19, 2010.
No additional wash out, run-in, or transition was utilized during this study.
Participant milestones
| Measure |
Cardioblate Surgical Ablation System
75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 3 subjects died, 7 subjects withdrew from the study, 2 subjects missed the endpoint visit, and 1 subject was lost to follow-up.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Cardioblate Surgical Ablation System
75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 3 subjects died, 7 subjects withdrew from the study, 2 subjects missed the endpoint visit, and 1 subject was lost to follow-up.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Death
|
3
|
|
Overall Study
Missed Endpoint Visit
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
Baseline characteristics by cohort
| Measure |
Entire Cohort
n=75 Participants
All subjects enrolled and treated with the Cardioblate Surgical Ablation System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
58 Participants
n=5 Participants
|
|
Age Continuous
|
70.9 years
STANDARD_DEVIATION 8.7 • 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: 6 monthsPopulation: 75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.
Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.
Outcome measures
| Measure |
Cardioblate Surgical Ablation System
n=61 Participants
All subjects enrolled who completed a Holter assessment at 6 month follow-up.
|
|---|---|
|
Efficacy Endpoint: The Percent of Patients Off Class I and/or III Antiarrhythmic Drugs and Out of Atrial Fibrillation as Determined by 24 Hour Holter Recording Conducted at 6 Months Postoperatively.
|
37.7 percentage of participants
Interval 25.3 to 50.1
|
PRIMARY outcome
Timeframe: 30 days post procedure or hospital dischargePopulation: Entire study population.
Major Adverse Events included: 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 completed a Holter assessment at 6 month follow-up.
|
|---|---|
|
Safety Endpoint: Composite Acute Major Adverse Event Rate, Within 30 Days Post-procedure or Hospital Discharge
|
5.3 Percentage of subjects
Interval 0.0 to 11.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 75 subjects were enrolled. 14 subjects had no holter analysis performed- 1 LTFU, 3 died,7 withdrew participation, 3 subjects without analyzable holter data.
Outcome measures
| Measure |
Cardioblate Surgical Ablation System
n=61 Participants
All subjects enrolled who completed a Holter assessment at 6 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 6 Months
|
63.9 percentage of subjects
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.
Major Adverse Events included: 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=69 Participants
All subjects enrolled who completed a Holter assessment at 6 month follow-up.
|
|---|---|
|
Safety Endpoints: Composite 6-month Major Adverse Event Rate, Post-procedure
|
8.7 percentage of subjects
|
Adverse Events
Study Completion Cohort
Serious events: 46 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Completion Cohort
n=75 participants at risk
75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 4 subjects died, 8 subjects withdrew from the study, and 1 subject was lost to follow-up.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Hemmorrhage
|
4.0%
3/75 • Number of events 4 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Infection/Sepsis
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
18.7%
14/75 • Number of events 18 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
8.0%
6/75 • Number of events 6 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Pneumonia
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Respirator Distress Syndrome
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
6.7%
5/75 • Number of events 5 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
10.7%
8/75 • Number of events 9 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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)
|
|
Vascular disorders
Deep Vein Thrombosis
|
4.0%
3/75 • Number of events 3 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Aystole
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Cerebellar Hemorrhage
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Hematoma- rt psoas muscle
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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)
|
|
Vascular disorders
Entrapped SWAN-GANZ Catheter
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Hematuria
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Bradycardia
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Damaged PPM Lead
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Worstening Heart Failure
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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 Flutter
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Ventricular Tachycardia
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Ventricular Septal Defect
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Ventricular Tachycardia/Ventricular Fibrillation
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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)
|
|
Vascular disorders
Femoral Atery Psuedoaneurysm
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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)
|
|
Vascular disorders
Increased Blood Pressure
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Cholecystitis
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Colitis
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
2.7%
2/75 • Number of events 2 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Failure to Thrive
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
Post-op ileus/small bowel obstruction abdominal hernia repair
|
1.3%
1/75 • Number of events 1 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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. 62 subjects completed the study through 6 month follow-up. 4 subjects died, 8 subjects withdrew from the study, and 1 subject was lost to follow-up.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
5/75 • Number of events 5 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
21.3%
16/75 • Number of events 16 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
5.3%
4/75 • Number of events 4 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
5.3%
4/75 • Number of events 6 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
30.7%
23/75 • Number of events 23 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
5.3%
4/75 • Number of events 4 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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
|
8.0%
6/75 • Number of events 6 • Adverse events reported from treatment through 6 month follow-up.
This study was overseen by a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC). The DSMB made reviewed the data and 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