Trial Outcomes & Findings for Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR) (NCT NCT01463423)
NCT ID: NCT01463423
Last Updated: 2024-12-19
Results Overview
Local tumor control was assessed by CT, PET-CT, and, if appropriate, biopsy. The outcome was reported as the number of lesions that maintained tumor control for 1 year from the completion of Stereotactic Ablative Radiotherapy (SABR) treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
256 participants
Primary outcome timeframe
1 year
Results posted on
2024-12-19
Participant Flow
Participant milestones
| Measure |
Limited Primary Non-small Cell Lung Cancer (NSCLC)
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
History of NSCLC
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Advanced Lung Cancer Including Metastatic Lung Cancer
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
|---|---|---|---|
|
Overall Study
STARTED
|
84
|
87
|
85
|
|
Overall Study
COMPLETED
|
79
|
82
|
79
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR)
Baseline characteristics by cohort
| Measure |
Limited Primary Non-small Cell Lung Cancer (NSCLC)
n=84 Participants
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
History of NSCLC
n=87 Participants
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Advanced Lung Cancer Including Metastatic Lung Cancer
n=85 Participants
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
30-39
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
40-49
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Customized
50-59
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Customized
60-69
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Age, Customized
70-79
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Age, Customized
80-89
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Customized
90-99
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
76 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=5 Participants
|
85 participants
n=7 Participants
|
85 participants
n=5 Participants
|
253 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: In Groups 2 and 3, some participants had more than one lesion treated or analyzed. This explains why the total number of participants across specific outcome rows exceeds the overall number of participants in the arm/group.
Local tumor control was assessed by CT, PET-CT, and, if appropriate, biopsy. The outcome was reported as the number of lesions that maintained tumor control for 1 year from the completion of Stereotactic Ablative Radiotherapy (SABR) treatment.
Outcome measures
| Measure |
Limited Primary Non-small Cell Lung Cancer (NSCLC)
n=77 lesions
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
History of NSCLC
n=98 lesions
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Advanced Lung Cancer Including Metastatic Lung Cancer
n=100 lesions
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
|---|---|---|---|
|
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
25 Gray in 1 fraction for small peripheral tumors
|
34 lesions
|
70 lesions
|
60 lesions
|
|
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
50 Gray in 4 fractions for medium peripheral tumors
|
15 lesions
|
6 lesions
|
7 lesions
|
|
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
54 Gray in 3 fractions for large peripheral tumors
|
7 lesions
|
2 lesions
|
2 lesions
|
|
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
40 Gray in 4 fractions for small central tumors
|
8 lesions
|
14 lesions
|
19 lesions
|
|
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
50 Gray in 4 fractions for medium central tumors
|
8 lesions
|
4 lesions
|
11 lesions
|
|
Evaluate Local Tumor Control With Individually-optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors.
60 Gray in 8 fractions for large central tumors
|
5 lesions
|
2 lesions
|
1 lesions
|
SECONDARY outcome
Timeframe: 1 yearPopulation: In Groups 2 and 3, some participants had more than one lesion treated or analyzed. This explains why the total number of participants across specific outcome rows exceeds the overall number of participants in the arm/group.
In concept, toxicity refers to adverse events caused by an intervention, ie, related adverse events. Toxicity will be assessed on the basis of related pulmonary; esophageal; chest wall; skin; vascular; cardiac/pericardial; and neurologic adverse events. Such events may have a number of different preferred terms for the adverse effect. The outcome will be reported as the number of Grade 3 or higher adverse effect events (toxicities), by Common Terminology Criteria for Adverse Events (CTCAE) Body System. The following exceptions apply. * Gastrointestinal Disorders, Grade 4-5 only * Atelectasis (collapse of the lung or lobe), Grade 4-5 only * Grade 3 Hypoxia, only if worse than baseline All deaths related to treatment will be included. The outcome is numbers without dispersion.
Outcome measures
| Measure |
Limited Primary Non-small Cell Lung Cancer (NSCLC)
n=79 Participants
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
History of NSCLC
n=82 Participants
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Advanced Lung Cancer Including Metastatic Lung Cancer
n=79 Participants
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
|---|---|---|---|
|
Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
25 Gray in 1 fraction for small peripheral tumors
|
19 participants
|
31 participants
|
18 participants
|
|
Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
50 Gray in 4 fractions for medium peripheral tumors
|
8 participants
|
6 participants
|
3 participants
|
|
Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
54 Gray in 3 fractions for large peripheral tumors
|
3 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
40 Gray in 4 fractions for small central tumors
|
4 participants
|
9 participants
|
6 participants
|
|
Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
50 Gray in 4 fractions for medium central tumors
|
8 participants
|
3 participants
|
4 participants
|
|
Number of Participants With Treatment-Related Toxicity Following Individually-Optimized Stereotactic Ablative Radiotherapy (SABR) for Lung Tumors
60 Gray in 8 fractions for large central tumors
|
4 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Data were not collected
Radiotherapeutic dose levels to the tumor lesion may be limited by the proximity of critical organs. Reduced dose levels is believed to be associated with reduced therapeutic effect. This study will assess an anatomically-optimized audio-visual biofeedback (AVB)-coached breath-hold technique assisted by fast radiotherapy delivery. Holding breath at a particular point in the breathing cycle may minimize proximity between tumor lesions and critical organs. In summary, participants will be coached to breath-hold at a certain point in their normal breathing cycle, and radiation will be quickly administered in bursts for several seconds. Up to 12 to 15 cycles of breath-hold may be needed to administer the desired dose level. Feasibility of this technique will be assessed as the number of patients able to reproduce the optimized breath-hold. The outcome is a number without dispersion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Data were not collected
Radiotherapeutic dose levels to the tumor lesion may be limited by the proximity of critical organs. Reduced dose levels is believed to be associated with reduced therapeutic effect. This study will assess an anatomically-optimized audio-visual biofeedback (AVB)-coached breath-hold technique assisted by fast radiotherapy delivery. Holding breath at a particular point in the breathing cycle may minimize proximity between tumor lesions and critical organs. In summary, participants will be coached to breath-hold at a certain point in their normal breathing cycle, and radiation will be quickly administered in bursts for several seconds. Up to 12 to 15 cycles of breath-hold may be needed to administer the desired dose level. Utility of this technique will be assessed as the difference in treatment delivery time compared to free-breathing treatment, reported as the median with standard deviation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Participants with available data
Progression-free survival (PFS) is a measure of participant survival without disease recurrence, relapse, metastasis, or progression. The outcome is reported as the number of participants who were alive 2 years after the completion of Stereotactic Ablative Radiotherapy (SABR) treatment, and without disease progression during that time. The outcome is a number without dispersion.
Outcome measures
| Measure |
Limited Primary Non-small Cell Lung Cancer (NSCLC)
n=79 Participants
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
History of NSCLC
n=75 Participants
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Advanced Lung Cancer Including Metastatic Lung Cancer
n=79 Participants
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
|---|---|---|---|
|
Number of Participants With Progression-free Survival (PFS)
50 Gray in 4 fractions for medium peripheral tumors
|
9 participants
|
3 participants
|
3 participants
|
|
Number of Participants With Progression-free Survival (PFS)
54 Gray in 3 fractions for large peripheral tumors
|
4 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Progression-free Survival (PFS)
40 Gray in 4 fractions for small central tumors
|
4 participants
|
9 participants
|
10 participants
|
|
Number of Participants With Progression-free Survival (PFS)
50 Gray in 4 fractions for medium central tumors
|
5 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Progression-free Survival (PFS)
60 Gray in 8 fractions for large central tumors
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Progression-free Survival (PFS)
25 Gray in 1 fraction for small peripheral tumors
|
23 participants
|
26 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants with available data
Metastasis refers to the ability of cancer cells to break free of a tumor, and migrate to another location in the body and start a new tumor lesion. Metastasis-free survival (MFS) is a measure of participant survival without disease metastasis. The outcome is reported as the number of participants who were alive 2 years after the completion of Stereotactic Ablative Radiotherapy (SABR) treatment, and without documented metastasis in that time. The outcome is a number without dispersion.
Outcome measures
| Measure |
Limited Primary Non-small Cell Lung Cancer (NSCLC)
n=79 Participants
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
History of NSCLC
n=75 Participants
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Advanced Lung Cancer Including Metastatic Lung Cancer
n=79 Participants
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
|---|---|---|---|
|
Number of Participants With Metastasis-free Survival (MFS)
25 Gray in 1 fraction for small peripheral tumors
|
23 participants
|
26 participants
|
14 participants
|
|
Number of Participants With Metastasis-free Survival (MFS)
50 Gray in 4 fractions for medium peripheral tumors
|
9 participants
|
3 participants
|
3 participants
|
|
Number of Participants With Metastasis-free Survival (MFS)
54 Gray in 3 fractions for large peripheral tumors
|
4 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Metastasis-free Survival (MFS)
40 Gray in 4 fractions for small central tumors
|
4 participants
|
9 participants
|
10 participants
|
|
Number of Participants With Metastasis-free Survival (MFS)
50 Gray in 4 fractions for medium central tumors
|
5 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Metastasis-free Survival (MFS)
60 Gray in 8 fractions for large central tumors
|
3 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants with available data
Overall survival (OS) is a measure of participant survival without regard to disease status. The outcome is reported as the number of participants who were documented as alive 2 years after the completion of Stereotactic Ablative Radiotherapy (SABR) treatment. The outcome is a number without dispersion.
Outcome measures
| Measure |
Limited Primary Non-small Cell Lung Cancer (NSCLC)
n=79 Participants
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
History of NSCLC
n=75 Participants
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Advanced Lung Cancer Including Metastatic Lung Cancer
n=79 Participants
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
|---|---|---|---|
|
Number of Participants With Overall Survival (OS)
50 Gray in 4 fractions for medium peripheral tumors
|
13 participants
|
4 participants
|
6 participants
|
|
Number of Participants With Overall Survival (OS)
54 Gray in 3 fractions for large peripheral tumors
|
6 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Overall Survival (OS)
40 Gray in 4 fractions for small central tumors
|
5 participants
|
12 participants
|
15 participants
|
|
Number of Participants With Overall Survival (OS)
50 Gray in 4 fractions for medium central tumors
|
5 participants
|
4 participants
|
7 participants
|
|
Number of Participants With Overall Survival (OS)
60 Gray in 8 fractions for large central tumors
|
4 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Overall Survival (OS)
25 Gray in 1 fraction for small peripheral tumors
|
28 participants
|
38 participants
|
34 participants
|
Adverse Events
Limited Primary Non-small Cell Lung Cancer (NSCLC)
Serious events: 4 serious events
Other events: 52 other events
Deaths: 34 deaths
History of NSCLC
Serious events: 3 serious events
Other events: 60 other events
Deaths: 25 deaths
Advanced Lung Cancer Including Metastatic Lung Cancer
Serious events: 1 serious events
Other events: 40 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Limited Primary Non-small Cell Lung Cancer (NSCLC)
n=84 participants at risk
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
History of NSCLC
n=87 participants at risk
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Advanced Lung Cancer Including Metastatic Lung Cancer
n=85 participants at risk
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
3/84 • Number of events 3 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/84 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection (pneumonia)
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/84 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
1.2%
1/85 • Number of events 1 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
Other adverse events
| Measure |
Limited Primary Non-small Cell Lung Cancer (NSCLC)
n=84 participants at risk
Participants with limited primary NSCLCs (graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
History of NSCLC
n=87 participants at risk
Participants with prior history of NSCLC and new limited primary NSCLC lesion(s)
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
Advanced Lung Cancer Including Metastatic Lung Cancer
n=85 participants at risk
Participants with more advanced lung cancer or lung metastases from a variety of different cancers.
iSABR, 25 Gray in 1 fraction for small peripheral tumors: Radiotherapy procedure for participants with small peripheral tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium peripheral tumors: Radiotherapy procedure for participants with medium peripheral tumors \> 10 cc and ≤ 30 cc.
iSABR, 54 Gray in 3 fractions for large peripheral tumors: Radiotherapy procedure for participants with large peripheral tumors \> 30 cc.
iSABR, 40 Gray in 4 fractions for small central tumors: Radiotherapy procedure for participants with small central tumors ≤ 10 cc.
iSABR, 50 Gray in 4 fractions for medium central tumors: Radiotherapy procedure for participants with medium central tumors \> 10 cc and ≤ 30 cc.
iSABR, 60 Gray in 8 fractions for large central tumors: Radiotherapy procedure for participants with large central tumors \> 30 cc.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
40.5%
34/84 • Number of events 41 • Up to 7 years
|
44.8%
39/87 • Number of events 49 • Up to 7 years
|
29.4%
25/85 • Number of events 29 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
33.3%
28/84 • Number of events 34 • Up to 7 years
|
34.5%
30/87 • Number of events 32 • Up to 7 years
|
18.8%
16/85 • Number of events 19 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
13.1%
11/84 • Number of events 13 • Up to 7 years
|
23.0%
20/87 • Number of events 23 • Up to 7 years
|
17.6%
15/85 • Number of events 19 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
22.6%
19/84 • Number of events 29 • Up to 7 years
|
16.1%
14/87 • Number of events 15 • Up to 7 years
|
3.5%
3/85 • Number of events 3 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
7/84 • Number of events 8 • Up to 7 years
|
5.7%
5/87 • Number of events 5 • Up to 7 years
|
4.7%
4/85 • Number of events 4 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
4/84 • Number of events 5 • Up to 7 years
|
5.7%
5/87 • Number of events 6 • Up to 7 years
|
5.9%
5/85 • Number of events 5 • Up to 7 years
|
|
General disorders
Fatigue
|
4.8%
4/84 • Number of events 4 • Up to 7 years
|
3.4%
3/87 • Number of events 3 • Up to 7 years
|
1.2%
1/85 • Number of events 1 • Up to 7 years
|
|
Gastrointestinal disorders
Esophagitis
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
3.4%
3/87 • Number of events 3 • Up to 7 years
|
3.5%
3/85 • Number of events 3 • Up to 7 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
2/84 • Number of events 2 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
2.4%
2/85 • Number of events 2 • Up to 7 years
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
2.3%
2/87 • Number of events 2 • Up to 7 years
|
1.2%
1/85 • Number of events 1 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/84 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
2.4%
2/85 • Number of events 2 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/84 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/84 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
1.2%
1/85 • Number of events 1 • Up to 7 years
|
|
Investigations
Platelet count decreased
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/84 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/84 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/84 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/84 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
1.2%
1/85 • Number of events 1 • Up to 7 years
|
|
Investigations
Weight loss
|
0.00%
0/84 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/84 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
1.2%
1/85 • Number of events 1 • Up to 7 years
|
|
Nervous system disorders
Dizziness
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
1/84 • Number of events 1 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/84 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/84 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
1.2%
1/85 • Number of events 1 • Up to 7 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/84 • Up to 7 years
|
0.00%
0/87 • Up to 7 years
|
1.2%
1/85 • Number of events 1 • Up to 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/84 • Up to 7 years
|
1.1%
1/87 • Number of events 1 • Up to 7 years
|
0.00%
0/85 • Up to 7 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place