Trial Outcomes & Findings for Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer (NCT NCT00107172)
NCT ID: NCT00107172
Last Updated: 2019-10-18
Results Overview
Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
224 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2019-10-18
Participant Flow
Two hundred twenty-four (224) participants were accrued between January 2006 and January 2010.
One participant on SR arm was enrolled from a site with a regulatory violation and 1 participant on SR+BX arm had no surgery. These two participants were excluded from all analyses.
Participant milestones
| Measure |
Arm A (SR)
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
108
|
|
Overall Study
COMPLETED
|
109
|
103
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Arm A (SR)
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Other Reason
|
4
|
3
|
Baseline Characteristics
Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A (SR)
n=114 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
72 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
107 participants
n=7 Participants
|
221 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)Performance Status
0 = Asymptomatic and fully active
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)Performance Status
1= Symptomatic and fully ambulatory
|
66 participants
n=5 Participants
|
60 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)Performance Status
2= Symptomatic and ambulatory
|
28 participants
n=5 Participants
|
23 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Clinical Nodule Size (cm)
<= 2 cm
|
73 participants
n=5 Participants
|
67 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Clinical Nodule Size (cm)
> 2 cm
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Tumor Stage
T1=Tumor <=3cm
|
114 participants
n=5 Participants
|
104 participants
n=7 Participants
|
218 participants
n=5 Participants
|
|
Tumor Stage
T2=Tumor > 3cm
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Tumor Stage
T3=Tumor of any size
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Metastatis stage, M0
|
114 participants
n=5 Participants
|
108 participants
n=7 Participants
|
222 participants
n=5 Participants
|
|
Nodal Stage, N0
|
114 participants
n=5 Participants
|
108 participants
n=7 Participants
|
222 participants
n=5 Participants
|
|
Baseline diffusing capacity of the lung for carbon monoxide (DLCO)
|
47 Percentage of predicted
n=5 Participants
|
45 Percentage of predicted
n=7 Participants
|
46 Percentage of predicted
n=5 Participants
|
|
Baseline Forced Expiratory Volume in 1 second (FEV1)
|
48 Percentage of Predicted
n=5 Participants
|
53 Percentage of Predicted
n=7 Participants
|
50 Percentage of Predicted
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All intent-to-treat (ITT) participants.
Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.
Outcome measures
| Measure |
Arm A (SR)
n=114 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Time to Local Recurrence
|
NA years
The median and 95% confidence interval to local recurrence has not been attained because of the insufficient number of participants with events.
|
NA years
The median and 95% confidence interval of time to local recurrence has not been attained because of the insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All intent-to-treat (ITT) participants
OS was defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Arm A (SR)
n=114 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Overall Survival (OS)
|
5.3 years
Interval 3.8 to
The upper limit of 95% confidence interval of median survival time has not been attained because of the insufficient number of participants with events.
|
4.7 years
Interval 3.9 to
The upper limit of 95% confidence interval of median survival time has not been attained because of the insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All intent-to-treat participants.
Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.
Outcome measures
| Measure |
Arm A (SR)
n=114 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Number of Participants Reported Local Recurrence at 3 Years
|
14 participants
|
13 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All intent-to-treat participants.
Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.
Outcome measures
| Measure |
Arm A (SR)
n=114 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Number of Participants Reported Regional Recurrence at 3 Years
|
8 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: All intent-to-treat participants.
Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant\> metastatic disease (other organs).
Outcome measures
| Measure |
Arm A (SR)
n=114 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Number of Participants Reported Distant Recurrence at 3 Years
|
10 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: All Intent-to-Treat (ITT) participants
Outcome measures
| Measure |
Arm A (SR)
n=114 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Mortality Rates at 30- and 90-day After Sublobar Resection
0 - 30 days
|
0.9 percentage of participants
|
1.9 percentage of participants
|
|
Mortality Rates at 30- and 90-day After Sublobar Resection
0 - 90 days
|
2.6 percentage of participants
|
2.8 percentage of participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: All Intent-to-Treat (ITT) participants.
Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Outcome measures
| Measure |
Arm A (SR)
n=114 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
0 - 30 days
|
29 participants
|
33 participants
|
|
Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection
0 - 90 days
|
34 participants
|
40 participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: All Intent-to-Treat (ITT) participants.
The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.
Outcome measures
| Measure |
Arm A (SR)
n=114 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection
0 - 30 days
|
17 participants
|
4 participants
|
|
Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection
0 - 90 days
|
22 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Participants who met the eligibility criteria and had SF 36 data at baseline, month 3, 12 or 24.
Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores \<50 indicate below-average health status.
Outcome measures
| Measure |
Arm A (SR)
n=108 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=104 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Baseline PCS Scores
|
43.2 units on a scale
Interval 21.8 to 62.3
|
41.8 units on a scale
Interval 24.0 to 65.1
|
|
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Baseline MCS Scores
|
51.4 units on a scale
Interval 12.2 to 68.6
|
50.5 units on a scale
Interval 17.8 to 69.4
|
|
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Month 3 PCS Scores
|
43.2 units on a scale
Interval 19.5 to 61.3
|
42.4 units on a scale
Interval 27.4 to 65.9
|
|
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Month 3 MCS Scores
|
51.8 units on a scale
Interval 22.2 to 68.7
|
52.2 units on a scale
Interval 17.6 to 64.0
|
|
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Month 12 PCS Scores
|
42.8 units on a scale
Interval 18.8 to 60.0
|
42.8 units on a scale
Interval 27.6 to 64.2
|
|
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Month 12 MCS Scores
|
52.5 units on a scale
Interval 22.8 to 69.3
|
51.3 units on a scale
Interval 14.0 to 64.3
|
|
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Month 24 PCS Scores
|
44.6 units on a scale
Interval 16.0 to 63.0
|
42.4 units on a scale
Interval 28.2 to 64.9
|
|
Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24
Month 24 MCS Scores
|
54.1 units on a scale
Interval 16.5 to 69.1
|
51.2 units on a scale
Interval 28.8 to 65.5
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Participants who met the eligibility criteria and had SOBQ data at baseline, month 3, 12 or 24.
Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..
Outcome measures
| Measure |
Arm A (SR)
n=108 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=104 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24
Baseline SOBQ Scores
|
72.9 units on a scale
Interval 5.8 to 100.0
|
70.0 units on a scale
Interval 5.8 to 98.3
|
|
Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24
Month 3 SOBQ Scores
|
75.8 units on a scale
Interval 16.7 to 100.0
|
69.2 units on a scale
Interval 20.8 to 100.0
|
|
Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24
Month 12 SOBQ Scores
|
72.5 units on a scale
Interval 13.3 to 100.0
|
72.1 units on a scale
Interval 0.0 to 100.0
|
|
Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24
Month 24 SOBQ Scores
|
70.8 units on a scale
Interval 4.2 to 100.0
|
63.8 units on a scale
Interval 5.8 to 95.8
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All participants with complete pulmonary function test data at baseline and month 3.
Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms
Outcome measures
| Measure |
Arm A (SR)
n=74 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=74 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
FEV1% Measured at Baseline and Month 3
Baseline FEV1%
|
49 Percentage of Predicted
Interval 22.0 to 117.0
|
51 Percentage of Predicted
Interval 25.0 to 110.0
|
|
FEV1% Measured at Baseline and Month 3
Month 3 FEV1%
|
53 Percentage of Predicted
Interval 24.0 to 101.0
|
53 Percentage of Predicted
Interval 24.0 to 104.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All participants with complete pulmonary function test data at baseline and month 3.
Pulmonary function tests included percentage predicted carbon \> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms.
Outcome measures
| Measure |
Arm A (SR)
n=74 Participants
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=74 Participants
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
DLCO% Measured at Baseline and Month 3
Baseline DLCO%
|
46 Percentage of Predicted
Interval 18.0 to 97.0
|
46 Percentage of Predicted
Interval 10.0 to 137.0
|
|
DLCO% Measured at Baseline and Month 3
Month 3 DLCO%
|
48 Percentage of Predicted
Interval 14.0 to 144.0
|
43 Percentage of Predicted
Interval 5.0 to 96.0
|
Adverse Events
Arm A (SR)
Serious events: 8 serious events
Other events: 45 other events
Deaths: 0 deaths
Arm B (SR + BX)
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (SR)
n=114 participants at risk
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 participants at risk
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Cardiac disorders
Cardiac disorder
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Eye disorders
Vision blurred
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Gastrointestinal disorders
Ascites
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Gastrointestinal disorders
Colitis
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Infections and infestations
Infection
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Infections and infestations
Pneumonia
|
2.6%
3/114 • Number of events 3 • 24 months
|
0.00%
0/108 • 24 months
|
|
Injury, poisoning and procedural complications
Intraoperative neurological injury - NERVES: Recurrent laryngeal
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
1.8%
2/114 • Number of events 2 • 24 months
|
0.00%
0/108 • 24 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Psychiatric disorders
Confusion
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Vascular disorders
Hypertension
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Vascular disorders
Hypotension
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Vascular disorders
Peripheral ischemia
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Vascular disorders
Thrombosis
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Arm A (SR)
n=114 participants at risk
Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
|
Arm B (SR + BX)
n=108 participants at risk
Patients undergo sublobar resection plus brachytherapy (SR + BX)
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
1/114 • Number of events 1 • 24 months
|
2.8%
3/108 • Number of events 3 • 24 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Cardiac disorders
Cardiac pain
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Cardiac disorders
Myocardial ischemia
|
1.8%
2/114 • Number of events 2 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Enteritis
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Ileus
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
0.88%
1/114 • Number of events 1 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
General disorders
Chest pain
|
0.88%
1/114 • Number of events 1 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
General disorders
Fatigue
|
0.88%
1/114 • Number of events 1 • 24 months
|
3.7%
4/108 • Number of events 4 • 24 months
|
|
General disorders
Pain
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Infections and infestations
Abdominal infection
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Infections and infestations
Bladder infection
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Infections and infestations
Infection
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Infections and infestations
Pneumonia
|
7.0%
8/114 • Number of events 8 • 24 months
|
9.3%
10/108 • Number of events 11 • 24 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
1.8%
2/114 • Number of events 2 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Intraoperative respiratory injury - Lung
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
2.6%
3/114 • Number of events 3 • 24 months
|
5.6%
6/108 • Number of events 6 • 24 months
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Injury, poisoning and procedural complications
Prolonged intubation after pulmonary resection (>24 hrs after surgery)
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Investigations
ADH abnormal
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Investigations
Alanine aminotransferase increased
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Investigations
Creatinine increased
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Investigations
Leukocyte count decreased
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Investigations
Lymphocyte count decreased
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Investigations
Weight loss
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Acidosis
|
2.6%
3/114 • Number of events 3 • 24 months
|
0.00%
0/108 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.88%
1/114 • Number of events 1 • 24 months
|
2.8%
3/108 • Number of events 3 • 24 months
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
1.8%
2/114 • Number of events 2 • 24 months
|
0.00%
0/108 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/114 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.8%
2/114 • Number of events 2 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Nervous system disorders
Ataxia
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Nervous system disorders
Cognitive disturbance
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Nervous system disorders
Dizziness
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Nervous system disorders
Headache
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Psychiatric disorders
Confusion
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Renal and urinary disorders
Renal failure
|
0.88%
1/114 • Number of events 1 • 24 months
|
2.8%
3/108 • Number of events 3 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.8%
2/114 • Number of events 2 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.4%
21/114 • Number of events 21 • 24 months
|
25.0%
27/108 • Number of events 27 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.3%
6/114 • Number of events 6 • 24 months
|
9.3%
10/108 • Number of events 10 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
1/114 • Number of events 1 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.88%
1/114 • Number of events 1 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/114 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.6%
3/114 • Number of events 3 • 24 months
|
1.9%
2/108 • Number of events 2 • 24 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Vascular disorders
Hypotension
|
0.88%
1/114 • Number of events 1 • 24 months
|
2.8%
3/108 • Number of events 3 • 24 months
|
|
Vascular disorders
Peripheral ischemia
|
0.88%
1/114 • Number of events 1 • 24 months
|
0.00%
0/108 • 24 months
|
|
Vascular disorders
Thrombosis
|
5.3%
6/114 • Number of events 6 • 24 months
|
0.93%
1/108 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place