Trial Outcomes & Findings for Radical Resection Vs. Ablative Stereotactic Radiotherapy in Patients With Operable Stage I NSCLC (NCT NCT01753414)
NCT ID: NCT01753414
Last Updated: 2025-01-06
Results Overview
Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by positron PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original planning target volume (PTV). Local-regional control time is defined as time from randomization to the date of first LRF, death, or last known follow-up (censored), whichever occurred first. Rates are estimated using the Kaplan-Meier method.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
From date of randomization to two years
Results posted on
2025-01-06
Participant Flow
Of 47 participants registered to the first step of the study, 44 were randomized. Randomization required FDG-PET/CT (FDG = 18F-fluorodeoxyglucose; PET = positron emission tomography; CT = Computed Tomography) staging to confirm T1N0 disease, per American Joint Committee on Cancer (AJCC), 7th edition.
Participant milestones
| Measure |
Surgery
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized participants with data
Baseline characteristics by cohort
| Measure |
Surgery
n=22 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=22 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=22 Participants
|
67 years
n=22 Participants
|
65 years
n=44 Participants
|
|
Age, Customized
<50
|
1 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=44 Participants
|
|
Age, Customized
50-59
|
6 Participants
n=22 Participants
|
1 Participants
n=22 Participants
|
7 Participants
n=44 Participants
|
|
Age, Customized
60-69
|
11 Participants
n=22 Participants
|
13 Participants
n=22 Participants
|
24 Participants
n=44 Participants
|
|
Age, Customized
70-79
|
4 Participants
n=22 Participants
|
6 Participants
n=22 Participants
|
10 Participants
n=44 Participants
|
|
Age, Customized
≥80
|
0 Participants
n=22 Participants
|
2 Participants
n=22 Participants
|
2 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=22 Participants
|
10 Participants
n=22 Participants
|
19 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=22 Participants
|
12 Participants
n=22 Participants
|
25 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Region of Enrollment
China
|
22 participants
n=22 Participants
|
22 participants
n=22 Participants
|
44 participants
n=44 Participants
|
|
Zubrod performance status
0
|
6 Participants
n=22 Participants
|
5 Participants
n=22 Participants
|
11 Participants
n=44 Participants
|
|
Zubrod performance status
1
|
16 Participants
n=22 Participants
|
17 Participants
n=22 Participants
|
33 Participants
n=44 Participants
|
|
Histology
Squamous cell carcinoma
|
4 Participants
n=22 Participants
|
5 Participants
n=22 Participants
|
9 Participants
n=44 Participants
|
|
Histology
Adenocarcinoma
|
14 Participants
n=22 Participants
|
12 Participants
n=22 Participants
|
26 Participants
n=44 Participants
|
|
Histology
Non-small cell caarcinoma, NOS
|
4 Participants
n=22 Participants
|
5 Participants
n=22 Participants
|
9 Participants
n=44 Participants
|
|
Forced expiratory volume in one second (FEV1)
|
2.31 liters/second
n=22 Participants
|
2.15 liters/second
n=22 Participants
|
2.29 liters/second
n=44 Participants
|
|
Percent predicted FEV1
|
96.1 percentage
n=22 Participants • Randomized participants with data
|
90 percentage
n=21 Participants • Randomized participants with data
|
94 percentage
n=43 Participants • Randomized participants with data
|
|
Forced vital capacity (FVC)
|
3.2 liters/second
n=22 Participants
|
2.855 liters/second
n=22 Participants
|
2.96 liters/second
n=44 Participants
|
|
Percent predicted FVC
|
99 percentage
n=22 Participants • Randomized participants with data
|
98.7 percentage
n=21 Participants • Randomized participants with data
|
98.7 percentage
n=43 Participants • Randomized participants with data
|
|
Percent predicted Diffusing capacity for carbon monoxide (DLCO)
|
90 percentage
n=22 Participants • Randomized participants with data
|
89 percentage
n=20 Participants • Randomized participants with data
|
90 percentage
n=42 Participants • Randomized participants with data
|
PRIMARY outcome
Timeframe: From date of randomization to two yearsPopulation: Randomized participants with follow-up data
Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by positron PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original planning target volume (PTV). Local-regional control time is defined as time from randomization to the date of first LRF, death, or last known follow-up (censored), whichever occurred first. Rates are estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Surgery
n=21 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=21 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Percentage of Participants Alive Without Local-regional Failure at Two Years (Local-regional Tumor Control)
|
95.2 percentage of participants
Interval 70.7 to 99.3
|
66.7 percentage of participants
Interval 42.5 to 82.5
|
SECONDARY outcome
Timeframe: From date of randomization to date of death or last follow-up. Maximum follow-up was 7.0 years.Population: Randomized participants with follow-up data
Overall survival rates are estimated by the Kaplan-Meier method. The distribution of DFS estimates between the two arms is compared using the log rank test. Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Two-year rates are provided.
Outcome measures
| Measure |
Surgery
n=21 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=21 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Overall Survival (Percentage of Participants Alive)
|
85.7 percentage of participants
Interval 62.0 to 95.2
|
90.5 percentage of participants
Interval 67.0 to 97.5
|
SECONDARY outcome
Timeframe: From date of randomization to the date of first local-regional failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years.Population: Randomized participants with follow-up data
LRF rates are estimated using the cumulative incidence method. LRF is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum (N1 nodal region), mediastinum (N2-N3 nodes), ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, confirmed by PET/CT, within same lobe, hilum (N1 nodes), mediastinum (N2-N3 nodes), or ipsilateral supraclavicular fossa for upper lobe tumors (N3 nodes), or within 3 cm of original PTV. LRF time is defined as time from randomization to the date of first LRF, last known follow-up (censored), or death without LRF (competing risk), whichever occurred first. Two-year rates are provided.
Outcome measures
| Measure |
Surgery
n=21 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=21 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Percentage of Participants With Local-regional Failure (LRF)
|
4.8 percentage of participants
Interval 0.3 to 20.2
|
33.3 percentage of participants
Interval 14.4 to 53.6
|
SECONDARY outcome
Timeframe: From date of randomization to date of first distant failure, death, or last known follow-up, whichever occurred first. Maximum follow-up was 7.0 years.Population: Randomized participants with follow-up data
Distant failure rates are estimated using the cumulative incidence method. Distant failure is defined as appearance of tumor within another ipsilateral (non-primary) lobe ≥ 2 cm from the original planning target volume (PTV) or distant metastasis, including appearance of tumor deposits characteristic of NSCLC metastasis (chest wall other than incision sites, mediastinal structures/diaphragm, malignant pleural/pericardial effusion), contralateral lung and/or other distant sites. Time to distant failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Two-year rates are provided.
Outcome measures
| Measure |
Surgery
n=21 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=21 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Percentage of Participants With Distant Failure
|
23.8 percentage of participants
Interval 8.3 to 43.6
|
23.8 percentage of participants
Interval 8.4 to 43.6
|
SECONDARY outcome
Timeframe: From date of randomization to the date of first failure, death, or last known follow-up, whichever occurred first. Maximum follow-up is 7.0 years.Population: Randomized participants with follow-up data
Failure rates are estimated using the Kaplan-Meier method, where failure is defined as LRF, DF, or death from any cause. LRF is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at the resection site, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per RECIST criteria, confirmed by PET/CT, within same lobe, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of original PTV. DF is defined as tumor within a non-primary lobe ≥ 2 cm from the original planning target volume or distant metastasis. Failure time is defined as time from randomization to the date of first failure or last known follow-up (censored), whichever occurred first. Two-year rates are provided.
Outcome measures
| Measure |
Surgery
n=21 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=21 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Percentage of Participants Alive Without Disease [Disease-free Survival (DFS)]
|
65.0 percentage of participants
Interval 40.3 to 81.5
|
61.9 percentage of participants
Interval 38.1 to 78.8
|
SECONDARY outcome
Timeframe: From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years.Population: Randomized participants with follow-up data
Local-regional failure (LRF) is defined differently for each arm. LRF after RODS is defined as recurrence, defined by CT, confirmed by PET/CT whenever possible, i.e., development of tumor masses at site of resection, hilum, mediastinum, ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of the staple line of RODS. LRF after SBRT is defined as tumor progression on CT per RECIST criteria, confirmed by PET/CT, within same lobe, hilum, mediastinum, or ipsilateral supraclavicular fossa for upper lobe tumors, or within 3 cm of original planning target volume (PTV). Distant failure is defined as tumor within a non-primary lobe ≥ 2 cm from the original planning target volume or distant metastasis, including tumor deposits characteristic NSCLC metastasis (chest wall other than incision sites, mediastinal structures/diaphragm, malignant pleural/pericardial effusion), contralateral lung and/or other distant sites.
Outcome measures
| Measure |
Surgery
n=21 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=21 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Number of Participants by Failure Site
Local-regional failure (at any time)
|
2 Participants
|
9 Participants
|
|
Number of Participants by Failure Site
Distant failure (at any time)
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years.Population: Randomized participants with follow-up PET scan
PET Tumor Response of Irradiated Target Lesions is defined as * Complete Metabolic Response (CMR): Tumor 18F-fluorodeoxyglucose (FDG)-activity decreased to less than mean background of the aortic arch blood pool. * Partial Metabolic Response (PMR): At least a 30% decrease in the maximum of relative tumor FDG-activity of target lesions * Progressive Metabolic Disease (PMD): At least a 20% increase in the maximum of relative tumor FDG-activity of target lesions * Stable Metabolic Disease (SMD): Neither sufficient reduction to qualify for (major pathological response) PMR nor sufficient increase to qualify for PMD The percentage of decrease or increase was globally estimated based on readings of (tumor activity-aorta activity)/aorta activity.
Outcome measures
| Measure |
Surgery
n=3 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=4 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Best PET Tumor Response
Complete Metabolic Response
|
0 Participants
|
0 Participants
|
|
Best PET Tumor Response
Partial Metabolic Response
|
0 Participants
|
0 Participants
|
|
Best PET Tumor Response
Progressive Metabolic Disease
|
3 Participants
|
4 Participants
|
|
Best PET Tumor Response
Stable Metabolic Disease
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of randomization to the date of last known follow-up. Maximum follow-up time was 7.0 years.Population: Randomized participants who started protocol treatment
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Outcome measures
| Measure |
Surgery
n=16 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=19 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 2
|
6 Participants
|
3 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 5
|
0 Participants
|
0 Participants
|
|
Number of Participants by Highest Grade Adverse Event Reported
Grade 1
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Randomized participants
Outcome measures
| Measure |
Surgery
n=22 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=22 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Number of Participants With Surgical and Radiation Treatment Credentialing Completed and Documented Before Enrollment (Trial Feasibility)
|
22 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Randomized participants
Goal: 95% of participants retain eligibility status (meet all eligibility criteria) after central review by headquarters staff.
Outcome measures
| Measure |
Surgery
n=22 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=22 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Number of Eligible Participants (Trial Feasibility)
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Randomized participants
Outcome measures
| Measure |
Surgery
n=22 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=22 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Number of Participants With Baseline Forms Completed and Provided Within 30 Days of Randomization (Trial Feasibility)
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From date of randomization to date of last known follow-up. Maximum follow-up was 7.0 years.Population: Randomized participants
Goal: \< 3% of participants lost to follow-up.
Outcome measures
| Measure |
Surgery
n=22 Participants
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=22 Participants
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Number of Participants Lost to Follow-up (Trial Feasibility)
|
1 Participants
|
1 Participants
|
Adverse Events
Surgery
Serious events: 0 serious events
Other events: 13 other events
Deaths: 5 deaths
Stereotactic Body Radiation Therapy (SBRT)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 5 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Surgery
n=16 participants at risk
R0 resection (radical resection) with nodal dissection or sampling (RODS).
|
Stereotactic Body Radiation Therapy (SBRT)
n=19 participants at risk
Stereotactic Body Radiation Therapy (SBRT) given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
43.8%
7/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
15.8%
3/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders
Fever
|
0.00%
0/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
General disorders
Pain
|
43.8%
7/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
62.5%
10/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
25.0%
4/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.5%
2/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
4/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.5%
2/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
18.8%
3/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Blood bilirubin increased
|
18.8%
3/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
36.8%
7/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
CPK increased
|
12.5%
2/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Cardiac troponin T increased
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Cholesterol high
|
25.0%
4/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
21.1%
4/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Lymphocyte count decreased
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
26.3%
5/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Platelet count decreased
|
12.5%
2/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.5%
2/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
Weight loss
|
0.00%
0/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Investigations
White blood cell decreased
|
0.00%
0/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.5%
2/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
15.8%
3/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
36.8%
7/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
8/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
21.1%
4/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
3/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.8%
3/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
12.5%
2/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Renal and urinary disorders
Hemoglobinuria
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
10.5%
2/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
26.3%
5/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.8%
3/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
5.3%
1/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
12.5%
2/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
81.2%
13/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
15.8%
3/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
43.8%
7/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
52.6%
10/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.2%
1/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
0.00%
0/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
62.5%
10/16 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
78.9%
15/19 • Baseline to the date of last known follow-up. Maximum follow-up time was 7.0 years.
All-cause mortality was assessed in randomized participants with follow-up data. Adverse events were assessed in randomized participants who started protocol treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER