Trial Outcomes & Findings for Image-Guided Radiosurgery or Stereotactic Body Radiation Therapy in Treating Patients With Localized Spine Metastasis (NCT NCT00922974)
NCT ID: NCT00922974
Last Updated: 2025-04-29
Results Overview
Treatment delivery was centrally reviewed by the study chair and medical physics co-chair. Success was defined as having a review of "per protocol" or "minor variation". A 70% success rate was required for continuation to the phase III component. * Target volume compliance in is defined as the following levels of target coverage in reference to dose volume: * Per protocol: ≥ 90% * Minor variation: 80%-90% * Major deviation: \<80% of of dose volume. * Image-Guided Radiotherapy (IGRT) compliance is defined as the following differences in IGRT images between simulation/planning and treatment, as well as at the end of treatment: * Per protocol: \<2 mm * Minor variation: 2mm - 3mm * Major deviation: \> 3mm
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
399 participants
Primary outcome timeframe
The day of protocol treatment
Results posted on
2025-04-29
Participant Flow
Participant milestones
| Measure |
Radiosurgery/SBRT
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy. The phase III component allows 16 or 18 Gy as preferred by the treating physician.
|
External Beam Radiation Therapy
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Phase II Component
STARTED
|
46
|
0
|
|
Phase II Component
Eligible
|
44
|
0
|
|
Phase II Component
Eligible and Started Treatment
|
39
|
0
|
|
Phase II Component
Eligible, Treated, Adverse Event Data
|
34
|
0
|
|
Phase II Component
COMPLETED
|
39
|
0
|
|
Phase II Component
NOT COMPLETED
|
7
|
0
|
|
Phase III Component
STARTED
|
217
|
136
|
|
Phase III Component
Eligible
|
209
|
130
|
|
Phase III Component
Eligible With 3 mo. NRPS Data
|
139
|
76
|
|
Phase III Component
Eligible With 3 mo. FACT-G Data
|
87
|
58
|
|
Phase III Component
Eligible With Adverse Event Data
|
202
|
117
|
|
Phase III Component
Eligible, Treated, Adverse Event Data
|
148
|
83
|
|
Phase III Component
Eligible and Consented to Quality of Life Participate in Quality of Life (QOL) Study Component
|
152
|
100
|
|
Phase III Component
COMPLETED
|
209
|
130
|
|
Phase III Component
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Radiosurgery/SBRT
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy. The phase III component allows 16 or 18 Gy as preferred by the treating physician.
|
External Beam Radiation Therapy
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Phase II Component
Protocol Violation
|
2
|
0
|
|
Phase II Component
Not evaluable for treatment review
|
5
|
0
|
|
Phase III Component
Protocol Violation
|
8
|
6
|
Baseline Characteristics
Subjects who had a second metastasis
Baseline characteristics by cohort
| Measure |
Radiosurgery/SBRT (Phase II)
n=44 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
Radiosurgery/SBRT (Phase III)
n=209 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase III component allows 16 or 18 Gy as preferred by the treating physician.
|
External Beam Radiation Therapy
n=130 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
n=44 Participants
|
63 years
n=209 Participants
|
63 years
n=130 Participants
|
63 years
n=383 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=44 Participants
|
95 Participants
n=209 Participants
|
60 Participants
n=130 Participants
|
173 Participants
n=383 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=44 Participants
|
114 Participants
n=209 Participants
|
70 Participants
n=130 Participants
|
210 Participants
n=383 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=44 Participants
|
10 Participants
n=209 Participants
|
7 Participants
n=130 Participants
|
20 Participants
n=383 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=44 Participants
|
194 Participants
n=209 Participants
|
118 Participants
n=130 Participants
|
352 Participants
n=383 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=44 Participants
|
5 Participants
n=209 Participants
|
5 Participants
n=130 Participants
|
11 Participants
n=383 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=44 Participants
|
1 Participants
n=209 Participants
|
0 Participants
n=130 Participants
|
2 Participants
n=383 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=44 Participants
|
12 Participants
n=209 Participants
|
3 Participants
n=130 Participants
|
15 Participants
n=383 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=209 Participants
|
1 Participants
n=130 Participants
|
1 Participants
n=383 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=44 Participants
|
20 Participants
n=209 Participants
|
20 Participants
n=130 Participants
|
45 Participants
n=383 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=44 Participants
|
169 Participants
n=209 Participants
|
101 Participants
n=130 Participants
|
308 Participants
n=383 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
1 Participants
n=209 Participants
|
1 Participants
n=130 Participants
|
2 Participants
n=383 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
6 Participants
n=209 Participants
|
4 Participants
n=130 Participants
|
10 Participants
n=383 Participants
|
|
Zubrod performance status
0
|
13 Participants
n=44 Participants
|
51 Participants
n=209 Participants
|
34 Participants
n=130 Participants
|
98 Participants
n=383 Participants
|
|
Zubrod performance status
1
|
25 Participants
n=44 Participants
|
112 Participants
n=209 Participants
|
83 Participants
n=130 Participants
|
220 Participants
n=383 Participants
|
|
Zubrod performance status
2
|
6 Participants
n=44 Participants
|
46 Participants
n=209 Participants
|
13 Participants
n=130 Participants
|
65 Participants
n=383 Participants
|
|
Baseline Numerical Rating Pain Scale (NRPS)
|
7 units on a scale
n=44 Participants
|
7 units on a scale
n=209 Participants
|
7 units on a scale
n=130 Participants
|
7 units on a scale
n=383 Participants
|
|
Number of Spine Metastases
1
|
36 Participants
n=44 Participants
|
160 Participants
n=209 Participants
|
100 Participants
n=130 Participants
|
296 Participants
n=383 Participants
|
|
Number of Spine Metastases
2-3
|
8 Participants
n=44 Participants
|
49 Participants
n=209 Participants
|
30 Participants
n=130 Participants
|
87 Participants
n=383 Participants
|
|
Location of Index Spine Metastasis
C-1 to C-7
|
4 Participants
n=44 Participants
|
9 Participants
n=209 Participants
|
11 Participants
n=130 Participants
|
24 Participants
n=383 Participants
|
|
Location of Index Spine Metastasis
T-1 to T-6
|
6 Participants
n=44 Participants
|
36 Participants
n=209 Participants
|
19 Participants
n=130 Participants
|
61 Participants
n=383 Participants
|
|
Location of Index Spine Metastasis
T-7 to T-12
|
15 Participants
n=44 Participants
|
65 Participants
n=209 Participants
|
50 Participants
n=130 Participants
|
130 Participants
n=383 Participants
|
|
Location of Index Spine Metastasis
L-1 to L-5
|
19 Participants
n=44 Participants
|
99 Participants
n=209 Participants
|
50 Participants
n=130 Participants
|
168 Participants
n=383 Participants
|
|
Location of Spine Metastasis #2
C-1 to C-7
|
1 Participants
n=8 Participants • Subjects who had a second metastasis
|
0 Participants
n=49 Participants • Subjects who had a second metastasis
|
3 Participants
n=30 Participants • Subjects who had a second metastasis
|
4 Participants
n=87 Participants • Subjects who had a second metastasis
|
|
Location of Spine Metastasis #2
T-1 to T-6
|
2 Participants
n=8 Participants • Subjects who had a second metastasis
|
5 Participants
n=49 Participants • Subjects who had a second metastasis
|
5 Participants
n=30 Participants • Subjects who had a second metastasis
|
12 Participants
n=87 Participants • Subjects who had a second metastasis
|
|
Location of Spine Metastasis #2
T-7 to T-12
|
1 Participants
n=8 Participants • Subjects who had a second metastasis
|
14 Participants
n=49 Participants • Subjects who had a second metastasis
|
9 Participants
n=30 Participants • Subjects who had a second metastasis
|
24 Participants
n=87 Participants • Subjects who had a second metastasis
|
|
Location of Spine Metastasis #2
L-1 to L-5
|
4 Participants
n=8 Participants • Subjects who had a second metastasis
|
30 Participants
n=49 Participants • Subjects who had a second metastasis
|
13 Participants
n=30 Participants • Subjects who had a second metastasis
|
47 Participants
n=87 Participants • Subjects who had a second metastasis
|
|
Location of Spine Metastasis #3
T-1 to T-6
|
0 Participants
n=1 Participants • Subjects who had a third metastasis
|
1 Participants
n=6 Participants • Subjects who had a third metastasis
|
2 Participants
n=10 Participants • Subjects who had a third metastasis
|
3 Participants
n=17 Participants • Subjects who had a third metastasis
|
|
Location of Spine Metastasis #3
T-7 to T-12
|
0 Participants
n=1 Participants • Subjects who had a third metastasis
|
3 Participants
n=6 Participants • Subjects who had a third metastasis
|
5 Participants
n=10 Participants • Subjects who had a third metastasis
|
8 Participants
n=17 Participants • Subjects who had a third metastasis
|
|
Location of Spine Metastasis #3
L-1 to L-5
|
1 Participants
n=1 Participants • Subjects who had a third metastasis
|
2 Participants
n=6 Participants • Subjects who had a third metastasis
|
3 Participants
n=10 Participants • Subjects who had a third metastasis
|
6 Participants
n=17 Participants • Subjects who had a third metastasis
|
|
Taking Pain Medication
No
|
2 Participants
n=44 Participants
|
28 Participants
n=209 Participants
|
15 Participants
n=130 Participants
|
45 Participants
n=383 Participants
|
|
Taking Pain Medication
Yes
|
42 Participants
n=44 Participants
|
181 Participants
n=209 Participants
|
115 Participants
n=130 Participants
|
338 Participants
n=383 Participants
|
|
Type of Tumor
Radioresistant
|
—
|
29 Participants
n=209 Participants • This characteristic was not determined in the Phase II component.
|
15 Participants
n=130 Participants • This characteristic was not determined in the Phase II component.
|
44 Participants
n=339 Participants • This characteristic was not determined in the Phase II component.
|
|
Type of Tumor
Other
|
—
|
180 Participants
n=209 Participants • This characteristic was not determined in the Phase II component.
|
115 Participants
n=130 Participants • This characteristic was not determined in the Phase II component.
|
295 Participants
n=339 Participants • This characteristic was not determined in the Phase II component.
|
|
Intended Radiosurgery/SBRT Dose
16 Gy
|
44 Participants
n=44 Participants
|
115 Participants
n=209 Participants
|
76 Participants
n=130 Participants
|
235 Participants
n=383 Participants
|
|
Intended Radiosurgery/SBRT Dose
18 Gy
|
0 Participants
n=44 Participants
|
94 Participants
n=209 Participants
|
54 Participants
n=130 Participants
|
148 Participants
n=383 Participants
|
PRIMARY outcome
Timeframe: The day of protocol treatmentPopulation: Patients enrolled in the phase II component who were eligible and had treatment review information.
Treatment delivery was centrally reviewed by the study chair and medical physics co-chair. Success was defined as having a review of "per protocol" or "minor variation". A 70% success rate was required for continuation to the phase III component. * Target volume compliance in is defined as the following levels of target coverage in reference to dose volume: * Per protocol: ≥ 90% * Minor variation: 80%-90% * Major deviation: \<80% of of dose volume. * Image-Guided Radiotherapy (IGRT) compliance is defined as the following differences in IGRT images between simulation/planning and treatment, as well as at the end of treatment: * Per protocol: \<2 mm * Minor variation: 2mm - 3mm * Major deviation: \> 3mm
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=39 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Percentage of Patients Receiving Radiosurgery/SBRT Per Protocol or With Minor Variation (Phase II)
Target volume
|
39 Participants
|
—
|
|
Percentage of Patients Receiving Radiosurgery/SBRT Per Protocol or With Minor Variation (Phase II)
IGRT
|
37 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Eligible participants randomized in the phase III component with both baseline and 3 month NRPS scores
Pain is measured by the Numerical Rating Pain Scale (NRPS) a numerical 11-point scale (0-10) with 0 = no pain, 1-4 = mild, 5-6 = moderate, and 7-10 = severe with 10 the worst pain imaginable. Pain response is calculated as 3 month score - baseline score with a positive value indicating increased pain and a negative value indicating decreased pain. Patients with complete or partial pain response as defined below are considered responders. The index site is the lesion with the highest baseline (day of radiosurgery) pain score. If multiple sites have the same baseline pain score, the index site is the most cephalad lesion. * Complete response: post-treatment pain score of 0 at the index site, no increase in narcotic pain medication, and no increase in pain score at the secondary treated site(s). * Partial response: post-treatment improvement of at least 3 points at the index site, no increase in narcotic pain medication, and no increase in pain score at the secondary treated site(s).
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=139 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=76 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Percentage of Patients With Complete or Partial Pain Response at 3 Months (Phase III)
|
40.3 percentage of participants
Interval 32.0 to 49.0
|
57.9 percentage of participants
Interval 46.0 to 69.0
|
SECONDARY outcome
Timeframe: Baseline to two years. NRPS measured at baseline, 1, 2, and 3 weeks, 3, 6, 12, and 24 months.Population: Eligible participants randomized in the phase III component with pain response data
Pain is measured by the NRPS, a numerical 11-point scale from 0=no pain to 10=worst pain imaginable. Magnitude of pain response = post-baseline score - baseline score with a positive value indicating increased pain and a negative value indicating decreased pain. Pain response begins when a patient improves at least 3 points at the index site. (Although pain medication and pain response were part of the protocol definition of pain response, they were unable to be assessed accurately during weeks 1-3 and therefore were not included in the final definition used here.) Pain response time is defined as time from randomization to the date of pain response, last known follow-up (censored), or death (censored). Rates of participants with pain response are estimated using the Kaplan-Meier method. The distributions of pain response times are compared between the arms. Two-year rates are provided.
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=209 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=130 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Percentage of Participants With Pain Response Through Two Years (Phase III)
|
19.2 percentage of participants
Interval 11.6 to 26.8
|
19.2 percentage of participants
Interval 9.6 to 28.7
|
SECONDARY outcome
Timeframe: Randomization to two years. NRPS measured at baseline, 1, 2, and 3 weeks, 3, 6, 12, and 24 months.Population: Eligible participants randomized in the phase III component who experienced partial or complete pain response
Pain is measured by the NRPS, a numerical 11-point scale from 0=no pain to 10=worst pain imaginable. Amount of pain response = post-baseline score - baseline score with a positive value indicating increased pain and a negative value indicating decreased pain. Pain response begins when a patient improves at least 3 points at the index site. Pain response ends when when the pain score increases by 3 points (relapse). (Although pain medication and pain response were part of the protocol definition of pain response, they were unable to be assessed accurately during weeks 1-3 and therefore were not included in the final definition used here.) Pain relapse time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death (censored). Rates of participants with pain relapse are estimated using the Kaplan-Meier method. The distributions of pain relapse times are compared between the arms. Two-year rates are provided.
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=140 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=80 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Percentage of Participants With Pain Relapse Through Two Years (Phase III)
|
91.7 percentage of participants
Interval 84.9 to 98.6
|
96.9 percentage of participants
Interval 92.6 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPopulation: Eligible participants randomized in the phase III component with adverse event information
Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event (AE) 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 |
Radiosurgery/SBRT (Phase II)
n=202 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=117 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Percentage of Patients With Adverse Events at 3 Months (Phase III)
Treatment-related AE
|
7.4 percentage of participants
Interval 3.8 to 11.0
|
7.7 percentage of participants
Interval 2.8 to 12.5
|
|
Percentage of Patients With Adverse Events at 3 Months (Phase III)
Any AE
|
43.6 percentage of participants
Interval 36.7 to 50.0
|
36.7 percentage of participants
Interval 28.0 to 45.5
|
SECONDARY outcome
Timeframe: From randomization to two years.Population: Eligible participants randomized in the phase III component
Failure is defined as a vertebral compression fracture. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without compression fracture (competing risk). Failure rates are estimated using the cumulative incidence method. The distributions of failure times are compared between the arms. Two-year rates are provided.
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=209 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=130 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Percentage of Participants With a Vertebral Compression Fracture Through Two Years (Phase III)
|
19.5 percentage of participants
Interval 14.3 to 25.3
|
21.6 percentage of participants
Interval 14.6 to 29.6
|
SECONDARY outcome
Timeframe: From randomization to two yearsPopulation: Eligible participants randomized in the phase III component
Failure is defined as spinal cord damage. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without compression fracture (competing risk). Failure rates are estimated using the cumulative incidence method. The distributions of failure times are compared between the arms. Two-year rates are provided.
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=209 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=130 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Percentage of Participants With Spinal Cord Damage Through Two Years
|
3.6 percentage of participants
Interval 1.6 to 6.9
|
1.7 percentage of participants
Interval 0.3 to 5.4
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Eligible patients randomized in the phase III component who consented to QOL having both baseline and 3 month FACT-G total score.
The FACT-G is a validated 27-item measure in which a higher score represents higher quality of life (QOL). Physical, functional, social and emotional well-being subscale scores are added together to form the FACT-G total score. Responses range from 0=Not a lot to 4=Very much. Certain items must be reversed before being added, by subtracting the response from 4. Subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Total score ranges from 0-108; physical, social and functional subscales from 0-28; emotional subscale from 0-24. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing the subscale scores can be prorated. Change at 3 months is calculated as 3 month score - baseline score with a positive change indicating improvement in QOL.
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=87 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=58 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at 3 Months (Phase III)
|
2.4 score on a scale
Standard Deviation 16.0
|
5.2 score on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12, and 24 monthsPopulation: Questionnaires were not completed by all eligible participants randomized in the phase III component who consented to QOL. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.
The Brief Pain Inventory Worst Pain score measures self-reported worst pain in the last week. Possible scores range from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating a worse outcome. Change is calculated as baseline score subtracted from post-baseline score with a positive change indicating more pain.
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=152 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=100 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Change in Brief Pain Inventory (BPI) Worst Pain Score Through Two Years (Phase III)
3 months
|
-1.9 score on a scale
Standard Deviation 2.9
|
-2.0 score on a scale
Standard Deviation 3.3
|
|
Change in Brief Pain Inventory (BPI) Worst Pain Score Through Two Years (Phase III)
6 months
|
-2.3 score on a scale
Standard Deviation 2.9
|
-2.8 score on a scale
Standard Deviation 2.9
|
|
Change in Brief Pain Inventory (BPI) Worst Pain Score Through Two Years (Phase III)
12 months
|
-2.2 score on a scale
Standard Deviation 3.7
|
-2.3 score on a scale
Standard Deviation 2.9
|
|
Change in Brief Pain Inventory (BPI) Worst Pain Score Through Two Years (Phase III)
24 months
|
-1.4 score on a scale
Standard Deviation 3.3
|
-2.1 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12, and 24 monthsPopulation: Questionnaires were not completed by all eligible participants randomized in the phase III component who consented to QOL.. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.
The EQ-5D index score measures health status. Possible scores range from 0 (worst health state) to 1 (best health state), with higher scores indicating better health. Change is calculated as baseline score subtracted from post-baseline score with a positive change indicating improved health status.
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=152 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=100 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Change in EuroQol 5 Dimension (EQ-5D) Index Score Through Two Years (Phase III)
3 months
|
0.09 score on a scale
Standard Deviation 0.19
|
0.09 score on a scale
Standard Deviation 0.23
|
|
Change in EuroQol 5 Dimension (EQ-5D) Index Score Through Two Years (Phase III)
6 months
|
0.08 score on a scale
Standard Deviation 0.23
|
0.12 score on a scale
Standard Deviation 0.25
|
|
Change in EuroQol 5 Dimension (EQ-5D) Index Score Through Two Years (Phase III)
12 months
|
0.09 score on a scale
Standard Deviation 0.21
|
0.03 score on a scale
Standard Deviation 0.25
|
|
Change in EuroQol 5 Dimension (EQ-5D) Index Score Through Two Years (Phase III)
24 months
|
-0.02 score on a scale
Standard Deviation 0.26
|
-0.02 score on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12, and 24 monthsPopulation: Questionnaires were not completed by all eligible participants randomized in the phase III component who consented to QOL.. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.
The FACT-G total score gives a combined score of the four domains of health-related quality of life (HRQOL) in cancer patients: Physical, social, emotional, and functional well-being. Possible total scores range from 0 to 108 with higher scores indicating a better HRQOL. Change is calculated as baseline score subtracted from post-baseline score with a positive change indicating improvement in HRQOL.
Outcome measures
| Measure |
Radiosurgery/SBRT (Phase II)
n=152 Participants
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
External Beam Radiation Therapy
n=100 Participants
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Total Score Through Two Years (Phase III)
3 months
|
2.4 score on a scale
Standard Deviation 16.0
|
5.2 score on a scale
Standard Deviation 14.1
|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Total Score Through Two Years (Phase III)
6 months
|
5.7 score on a scale
Standard Deviation 16.6
|
5.0 score on a scale
Standard Deviation 15.8
|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Total Score Through Two Years (Phase III)
12 months
|
0.9 score on a scale
Standard Deviation 16.6
|
2.9 score on a scale
Standard Deviation 20.0
|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G) Total Score Through Two Years (Phase III)
24 months
|
-3.8 score on a scale
Standard Deviation 16.7
|
-2.1 score on a scale
Standard Deviation 14.1
|
Adverse Events
Radiosurgery/SBRT (Phase II)
Serious events: 5 serious events
Other events: 30 other events
Deaths: 1 deaths
Radiosurgery/SBRT (Phase III)
Serious events: 19 serious events
Other events: 141 other events
Deaths: 144 deaths
External Beam Radiation Therapy
Serious events: 10 serious events
Other events: 76 other events
Deaths: 80 deaths
Serious adverse events
| Measure |
Radiosurgery/SBRT (Phase II)
n=34 participants at risk
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
Radiosurgery/SBRT (Phase III)
n=196 participants at risk
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase III component allows 16 or 18 Gy as preferred by the treating physician.
|
External Beam Radiation Therapy
n=117 participants at risk
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|---|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
1.7%
2/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Chills
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Disease progression
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Fatigue
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Fever
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
General symptom
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Infections and infestations
Catheter related infection [with unknown ANC]
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Infections and infestations
Pneumonia [with unknown ANC]
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Infections and infestations
Soft tissue infection [with unknown ANC]
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Infections and infestations
Stoma site infection [with normal or Grade 1-2 ANC]
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Hyperbilirubinemia
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
INR increased
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Lymphopenia
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Platelet count decreased
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
1.0%
2/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
2.6%
5/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
1.7%
2/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Nervous system disorders
Cognitive disturbance
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
2.6%
3/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Vascular disorders
Hypotension
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
Other adverse events
| Measure |
Radiosurgery/SBRT (Phase II)
n=34 participants at risk
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase II component uses 16 Gy.
|
Radiosurgery/SBRT (Phase III)
n=196 participants at risk
Single fraction dose image-guided radiosurgery / stereotactic body radiotherapy (SBRT). The phase III component allows 16 or 18 Gy as preferred by the treating physician.
|
External Beam Radiation Therapy
n=117 participants at risk
Single fraction dose of 8 Gy external beam radiation therapy
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.6%
13/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.4%
4/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
8.8%
3/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
19.9%
39/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
13.7%
16/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
13.8%
27/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
6/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Constipation
|
11.8%
4/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
16.3%
32/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
11.1%
13/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
11.2%
22/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
12.0%
14/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
4/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
4.1%
8/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Nausea
|
14.7%
5/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
21.4%
42/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
18.8%
22/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
11.2%
22/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.8%
8/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Chest pain
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.1%
12/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
2.6%
3/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Edema limbs
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
11.2%
22/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.0%
7/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Fatigue
|
8.8%
3/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
32.1%
63/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
26.5%
31/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Fever
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
7.1%
14/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
6/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
General symptom
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.1%
6/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.4%
4/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Pain [NOS]
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.6%
11/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
6/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
General disorders
Pain [other]
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
7.7%
15/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
10.3%
12/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
10/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.4%
4/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.7%
17/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
7.7%
9/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Alkaline phosphatase increased
|
8.8%
3/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
12.2%
24/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
7.7%
9/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
9.7%
19/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.5%
10/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Creatinine increased
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
10/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
4.3%
5/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Hyperbilirubinemia
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
10/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
4.3%
5/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Leukopenia
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
11.7%
23/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.8%
8/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Lymphopenia
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
10.2%
20/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
7.7%
9/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Platelet count decreased
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
12.2%
24/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
7.7%
9/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Investigations
Weight loss
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.6%
13/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.5%
10/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
14.3%
28/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.5%
10/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.6%
11/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
1.7%
2/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
16.3%
32/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
10.3%
12/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
15.3%
30/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.8%
8/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
14.8%
29/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.5%
10/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.7%
17/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
7.7%
9/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.7%
17/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.8%
8/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
41.2%
14/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
30.6%
60/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
25.6%
30/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.7%
5/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.6%
7/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.0%
7/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.2%
16/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
2.6%
3/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
11.7%
23/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.0%
7/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.1%
12/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
2.6%
3/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.6%
11/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.4%
4/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.8%
3/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.6%
13/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
1.7%
2/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
3/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
12.2%
24/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
10.3%
12/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.1%
12/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
4.3%
5/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
2.0%
4/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
2.6%
3/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.6%
6/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.7%
17/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.8%
8/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.6%
11/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
2.6%
3/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
10/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.8%
8/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Renal and urinary disorders
Urinary retention
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.4%
4/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Renal and urinary disorders
Urogenital disorder
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.6%
11/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
1.7%
2/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
8.7%
17/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
10.3%
12/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
16.3%
32/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
10.3%
12/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
10/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.4%
4/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
10/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
5.1%
6/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.00%
0/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.8%
3/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.51%
1/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.1%
6/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
2.6%
3/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Vascular disorders
Hypotension
|
5.9%
2/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.6%
13/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
0.85%
1/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
|
Vascular disorders
Thrombosis
|
2.9%
1/34 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
6.6%
13/196 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
3.4%
4/117 • Collected at 1, 3, 6, 12, and 24 months from randomization.
All-cause mortality reported for all enrolled patients. Adverse events reported for eligible patients who started protocol treatment and have adverse event data. This data was updated when 24 month secondary outcome measures were entered.
|
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