Trial Outcomes & Findings for SAbR For Oligometastatic Renal Cell Carcinoma (NCT NCT02956798)

Last Updated: 2026-08-31

Results Overview

The percentage of participants with more than 1 year time to systemic therapy (TTST) will be reported for this outcome. Initiation of systemic therapy \>1 year (delay in time) is a surrogate of progression free survival (PFS) and is defined as the time from the first day of SAbR to start of systemic therapy.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

1 Year

Results posted on

2026-08-31

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Ablative Body Radiation (SABR) Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SAbR For Oligometastatic Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Age, Continuous	71 years n=14 Participants
Sex: Female, Male Female	4 Participants n=14 Participants
Sex: Female, Male Male	19 Participants n=14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=14 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants

PRIMARY outcome

Timeframe: 1 Year

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Percentage of Participants With Delay in Time to Start of Systemic Therapy (TTST)	91 % of patients Interval 69.0 to 98.0

SECONDARY outcome

Timeframe: 5.7 years

Modified progression-free survival (mPFS) for patients with oligometastatic renal cell carcinoma who are treated with SAbR. Modified progression-free survival (mPFS) is defined as the survival interval without development of \>3 sites of new metastasis, new sites of metastases that are not amenable to SAbR treatment, a total of \>6 sites of metastasis that required SAbR, local failure at SAbR-treated site, or development of brain metastasis, with the definition of new metastasis and local failure (progression) as defined by RECIST. "Metastasis" in this entire protocol refers to extra-cranial metastasis unless otherwise specified.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Modified Progression-free Survival (mPFS) for Patients Who Are Treated With SAbR	40 months Interval 23.0 to 57.0

SECONDARY outcome

Timeframe: 5.7 years

Population: Out of 23 participants, only 9 patients went on to systemic therapy for which data was collected, analyzed and is reported in the data table below.

To evaluate progression on next line of systemic therapy as defined by RECIST 1.1 starting from mPFS (modified progression free survival). Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) Committee \[Eur J Cancer. 2009;45(2):228-247\]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=9 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Progression-free Survival on Systemic Therapy (PFS-ST)	5.7 months Interval 3.5 to 8.9

SECONDARY outcome

Timeframe: 5.7 years

Overall survival (OS), which is defined as the time between date of registration and the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Overall Survival (OS)	69 % 3 year OS Interval 45.0 to 84.0

SECONDARY outcome

Timeframe: 5.7 years

Cancer specific survival is defined as the time between date of registration and the date of death due to renal cell carcinoma.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Cancer Specific Survival (CSS)	87 % 3-year CSS rate Interval 65.0 to 96.0

SECONDARY outcome

Timeframe: 5.7 years

Radiographic progression with \>30% increase in the longest diameter of the treated lesions.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=69 lesions Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Local Control	100 % of SAbR treated lesions

SECONDARY outcome

Timeframe: 1.8 years

Population: Out of 23 only 10 participants were analyzed as they were the ones who had complete/ partial response.

Median response duration is defined as the time between the date a response (CR or PR) was first seen until date of progression. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) Committee \[Eur J Cancer. 2009;45(2):228-247\]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=10 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Median Response Duration	4.1 months Interval 3.0 to 5.4

SECONDARY outcome

Timeframe: 5.7 years

Interval time to development of new lesions that can be treated with additional local therapy- title would be this or a shortened version of it. Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Time to Development of New Lesions	36 months Interval 11.0 to Upper limit has not been reached due to insufficient event number

SECONDARY outcome

Timeframe: 5.7 years

To measure the time interval from registration to time to disease progression that cannot be treated with further local therapy and need to initiate or switch systemic therapy. Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Time to Disease Progression That Cannot be Treated	40 months Interval 16.0 to Upper limit has not been reached due to insufficient event number

SECONDARY outcome

Timeframe: 5.7years

Population: Grade 1,2,3,4,5 toxicities if they are unlikely, possibly, probably, and definitely related to treatment, have been counted.

Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Events have been counted if they are considered related to the investigational intervention included "possible," "probable," and "definite." To ensure transparency, all AEs with "unlikely" or greater attribution are included.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Toxicity Measurement	81 events

SECONDARY outcome

Timeframe: [Baseline-3mon (months)];(Baseline-9mon.);(Baseline-15mon.); (Baseline-21mon.);(Baseline-27mon.);(Baseline-33mon.)

Population: Patients who filled out questionnaires at the given time point were included for analysis

HRQOL will be measured using FACT-G questionnaire responses from baseline to certain time points (3, 9, 15,21,27,33 months) until the completion of follow ups. FACT-G is a measure that sums the functional wellbeing (FWB), physical wellbeing (PWB), the social/family well-being (S/FWB), and emotional wellbeing (EMB).FACT-G total score range (0-108); Higher values indicate a better HRQOL.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Change in Health-related Quality of Life (HRQOL) FACT-G Baseline versus 33 months	-0.5 change in response scores Interval -3.5 to 2.5
Change in Health-related Quality of Life (HRQOL) FACT-G Baseline versus 3 months	-1.1 change in response scores Interval -2.8 to 0.7
Change in Health-related Quality of Life (HRQOL) FACT-G Baseline versus 9 months	0.5 change in response scores Interval -1.9 to 2.9
Change in Health-related Quality of Life (HRQOL) FACT-G Baseline versus 15 months	0.0 change in response scores Interval -2.3 to 2.3
Change in Health-related Quality of Life (HRQOL) FACT-G Baseline versus 21 months	-0.1 change in response scores Interval -4.3 to 4.1
Change in Health-related Quality of Life (HRQOL) FACT-G Baseline versus 27 months	-0.2 change in response scores Interval -2.0 to 1.6

SECONDARY outcome

Timeframe: [Baseline-3mon (months)];(Baseline-9mon.);(Baseline-15mon.); (Baseline-21mon.);(Baseline-27mon.);(Baseline-33mon.)

Population: Patients who filled out questionnaires at the given time point were included for analysis

HRQOL will be measured using EQ-VAS (EuroQol- Visual analog scale) questionnaire at baseline and at specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. The EQ-VAS is a global measure of patient perception of their health ranging from 0-100, with 0 being the worst health they can imagine, and 100 being the best health they can imagine.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Change in Health-related Quality of Life (HRQOL) EQ-VAS Baseline versus 3 months	4 change in response scores Interval -6.5 to 14.4
Change in Health-related Quality of Life (HRQOL) EQ-VAS Baseline versus 9 months	8.8 change in response scores Interval -2.0 to 19.5
Change in Health-related Quality of Life (HRQOL) EQ-VAS Baseline versus 15 months	5.3 change in response scores Interval -4.0 to 14.7
Change in Health-related Quality of Life (HRQOL) EQ-VAS Baseline versus 21 months	5 change in response scores Interval -5.7 to 15.7
Change in Health-related Quality of Life (HRQOL) EQ-VAS Baseline versus 27 months	2 change in response scores Interval -5.1 to 9.1
Change in Health-related Quality of Life (HRQOL) EQ-VAS Baseline versus 33 months	-6.5 change in response scores Interval -25.7 to 12.7

SECONDARY outcome

Timeframe: Baseline, 3months

Population: Out of 23 subjects only 19 completed the questionnaire for which data has been reported in the data table below

HRQOL will be measured using EQ-5D (EuroQol- 5 Dimension) questionnaire at baseline and at certain specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including the domains - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=19 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Change in Health-related Quality of Life (HRQOL) EQ-5D at 3 Months At least 1 worsened domain	7 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 3 Months Atleast 1 improved domain	6 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 3 Months All domains unchanged	1 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 3 Months At least 1 improved and 1 worsened domain	5 Participants

SECONDARY outcome

Timeframe: Baseline, 9 months

Population: Out of 23 subjects only 13 completed the questionnaire for which data has been reported in the data table below

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=13 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Change in Health-related Quality of Life (HRQOL) EQ-5D at 9 Months Atleast 1 improved domain	5 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 9 Months All domains unchanged	4 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 9 Months At least 1 improved and 1 worsened domain	3 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 9 Months At least 1 worsened domain	1 Participants

SECONDARY outcome

Timeframe: Baseline, 15 months

Population: Out of 23 subjects only 12 completed the questionnaire for which data has been reported in the data table below

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=12 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Change in Health-related Quality of Life (HRQOL) EQ-5D at 15 Months Atleast 1 improved domain	4 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 15 Months All domains unchanged	3 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 15 Months At least 1 improved and 1 worsened domain	3 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 15 Months At least 1 worsened domain	2 Participants

SECONDARY outcome

Timeframe: Baseline, 21 months

Population: Out of 23 subjects only 8 completed the questionnaire for which data has been reported in the data table below

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=8 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Change in Health-related Quality of Life (HRQOL) EQ-5D at 21 Months Atleast 1 improved domain	2 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 21 Months All domains unchanged	2 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 21 Months At least 1 improved and 1 worsened domain	1 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 21 Months At least 1 worsened domain	3 Participants

SECONDARY outcome

Timeframe: Baseline, 27 months

Population: Out of 23 subjects only 5 completed the questionnaire for which data has been reported in the data table below

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=5 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Change in Health-related Quality of Life (HRQOL) EQ-5D at 27 Months Atleast 1 improved domain	1 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 27 Months All domains unchanged	1 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 27 Months At least 1 improved and 1 worsened domain	1 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 27 Months At least 1 worsened domain	2 Participants

SECONDARY outcome

Timeframe: Baseline, 33 months

Population: Out of 23 subjects only 4 completed the questionnaire for which data has been reported in the data table below

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=4 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Change in Health-related Quality of Life (HRQOL) EQ-5D at 33 Months Atleast 1 improved domain	1 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 33 Months All domains unchanged	2 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 33 Months At least 1 improved and 1 worsened domain	0 Participants
Change in Health-related Quality of Life (HRQOL) EQ-5D at 33 Months At least 1 worsened domain	1 Participants

SECONDARY outcome

Timeframe: [Baseline-3mon (months)];(Baseline-9mon.);(Baseline-15mon.); (Baseline-21mon.);(Baseline-27mon.);(Baseline-33mon.)

Population: Patients who filled out questionnaires at the given time point were included for analysis.

HRQOL will be measured using FKSI questionnaire at baseline and at certain specific timepoints (3,9,15,21,27,33 months) until the completion of follow ups. FKSI adds to the FACT-G (27 items) by including 15 items specific to kidney cancer patients. FKSI is a questionnaire for FACT-Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Change in Health-related Quality of Life (HRQOL) FKSI Baseline versus 3 Months	-3.6 change in response scores Interval -7.3 to 0.1
Change in Health-related Quality of Life (HRQOL) FKSI Baseline versus 9 Months	0.0 change in response scores Interval -3.7 to 3.7
Change in Health-related Quality of Life (HRQOL) FKSI Baseline versus 15 Months	-1.5 change in response scores Interval -4.4 to 1.3
Change in Health-related Quality of Life (HRQOL) FKSI Baseline versus 21 Months	-0.3 change in response scores Interval -8.2 to 7.7
Change in Health-related Quality of Life (HRQOL) FKSI Baseline versus 27 Months	-2.9 change in response scores Interval -7.9 to 2.1
Change in Health-related Quality of Life (HRQOL) FKSI Baseline versus 33 Months	-1.8 change in response scores Interval -6.5 to 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline [After Protocol Modification], at 3M (months) [Prior to Protocol Modification]

Population: Out of 23, only 20 subjects data (3M data for 6 subjects \& Baseline data for 14 subjects) were collected \& reported since 2 subjects didn't fill out any of cost sections, \& 3rd subject didn't have this QOL recorded at any time point. The limitation of lacking the paired aspect required for this analysis is explained in the Limitations and Caveats module.

Health care utilization data needed to assess costs will be obtained from the cost \& convenience questionnaire, which includes costs of hospitalization, treatment, ER visits, physician and clinic visits and medications. Markov modeling with probabilistic sensitivity analysis will be used to correlate quality-adjusted survival and cost. Cost-effective analysis (cost \& convenience questionnaire) will be given prior to treatment and at the time of progression.

Outcome measures

Outcome measures
Measure	Stereotactic Ablative Body Radiation (SABR) n=20 Participants Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Health-related Quality of Life (HRQOL) Cost-effectiveness Subjects for whom 3 months data collected [Prior to 2019 Protocol Modification]	204.00 dollars Interval 105.0 to 1299.0
Health-related Quality of Life (HRQOL) Cost-effectiveness Subjects for whom Baseline data collected [After Protocol modification in 2019]	351.40 dollars Interval 176.0 to 1739.0

Adverse Events

Stereotactic Ablative Body Radiation (SABR)

Serious events: 11 serious events

Other events: 23 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 participants at risk Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Respiratory, thoracic and mediastinal disorders Pneumonia	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Esophogeal Perforation	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Presyncope	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Atrial Fibrillation	8.7% 2/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.3% 1/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Pericardial effusion	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Nervous system disorders Stroke	4.3% 1/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Hypotension	4.3% 1/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders colonic perforation	4.3% 1/23 • Number of events 4 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Infections and infestations sepsis	4.3% 1/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Blood and lymphatic system disorders Anemia	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Blood and lymphatic system disorders Thromboembolic event	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders dyspnea	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Spinal fracture	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Atrial flutter	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders respiratory failure	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Obstruction gastric	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Cardiac disorders - Other, Congestive Heart Failure	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Nervous system disorders Nervous system disorders - Other, transient alteration of awareness	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)

Other adverse events

Other adverse events
Measure	Stereotactic Ablative Body Radiation (SABR) n=23 participants at risk Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR. Stereotactic ablative body radiation (SABR): SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
Gastrointestinal disorders abdominal distension	8.7% 2/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders abdominal pain	47.8% 11/23 • Number of events 12 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Renal and urinary disorders Acute kidney injury	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Hepatobiliary disorders Alanine Aminotransferase Increased	8.7% 2/23 • Number of events 4 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Hepatobiliary disorders Alkaline phosphatase increased	30.4% 7/23 • Number of events 7 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Immune system disorders Allergic Rhinitis	17.4% 4/23 • Number of events 4 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Skin and subcutaneous tissue disorders Alopecia	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Blood and lymphatic system disorders Anemia	52.2% 12/23 • Number of events 16 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Anorexia	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Psychiatric disorders Anxiety	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Gastrointestinal disorders-other-appetite change	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Arthritis	30.4% 7/23 • Number of events 7 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Arthalgia	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Hepatobiliary disorders Aspartate aminotransferase increased	8.7% 2/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Atrial Fibrillation	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Atrial Flutter	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Atrioventricular block first degree	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Back pain	43.5% 10/23 • Number of events 12 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Belching	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Blood bicarbonate decreased	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Blood bilirubin increased	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Blood lactate dehydrogenase increased	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Eye disorders Blurred vision	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Bone Pain	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Blood and lymphatic system disorders Bruising	21.7% 5/23 • Number of events 5 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Chest Pain	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Chills	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Constipation	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Cough	21.7% 5/23 • Number of events 7 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders creatinine increased	34.8% 8/23 • Number of events 11 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Psychiatric disorders Depression	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Skin and subcutaneous tissue disorders Dermatitis radiation	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Diarrhea	21.7% 5/23 • Number of events 5 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Nervous system disorders Dizziness	13.0% 3/23 • Number of events 6 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Dry eye	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders dry mouth	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Skin and subcutaneous tissue disorders Dry Skin	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Nervous system disorders Dysesthesia	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Dyspepsia	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Dysphagia	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Dyspnea	43.5% 10/23 • Number of events 11 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Renal and urinary disorders dysuria	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Ear and labyrinth disorders Ear and labyrinth disorders-Right middle ear effusion with retraction	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Ear and labyrinth disorders Ear pain	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Edema Limbs	26.1% 6/23 • Number of events 7 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Edema Trunk	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Blood and lymphatic system disorders Epistaxis	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Eye disorders Esophagitis	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Exostosis	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Nervous system disorders Extrapyramidal disorder (RESTLESS LEGS SYNDROME)	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Eye disorders Eye disorders - Other, specify: Double vision	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Eye disorders Eye pain	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Fall	26.1% 6/23 • Number of events 6 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Fatigue	65.2% 15/23 • Number of events 17 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders fever	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Flank Pain	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Flu-like symptoms	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Gastroesophageal Reflux Disease	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Gastrointestinal disorders - Other, Diverticulitis	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Gastrointestinal disorders - Other, Increase in bowel frequency	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: Dark stools	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Gastrointestinal disorders - other: hypertrophy of tongue papillae or black hairy tongue	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Gastrointestinal disorders - other; Gastro-pleural fistula	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders General disorders - other specify - low phosphorus level	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders General disorders and administration site conditions - Other, Night sweats	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Generalized muscle weakness	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders GI disorders - other; Gastric Ulcer	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Headache	17.4% 4/23 • Number of events 9 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Ear and labyrinth disorders Hearing loss	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Renal and urinary disorders Hematuria	21.7% 5/23 • Number of events 5 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Hepatobiliary disorders Hepatobiliary disorders other - hepatic portal congestion	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Serum amylase increased	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Hot Flashes	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Hyperchloremia	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Hyperglycemia	13.0% 3/23 • Number of events 4 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Hyperhydrosis	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Hyperkalemia	17.4% 4/23 • Number of events 4 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Hypermagnesemia	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Endocrine disorders Hyperparathyroidism	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Hypertension	17.4% 4/23 • Number of events 6 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Hypocalcemia	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders hypochloremia	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Hypokalemia	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Hypomagnesemia	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Hyponatremia	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Cardiac disorders Hypotension	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Infections and infestations Infections and infestations - Other, specify: COVID-19	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Infections and infestations Infections and infestations-Purulent drainage infection	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Injury, poisoning and procedural complications Injury, poisoning and proccedural complications - scalp laceration	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, Hand injury (s/p fall)	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations INR increased	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Insomnia	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations - Other, decreased absolute lymphocytes	26.1% 6/23 • Number of events 6 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations - Other, decreased eGFR	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations - Other, decreased protein	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations - Other, increased BUN	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations - other; Platelet count increased	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations- Other, increased protein	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations- Other, leukocyte esterase in urine	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations, Other- increased absolute neutrophil count	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations-Other, increased absolute immature granulocytes	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations-Other, increased absolute monocytes	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Investigations-Other, decreased absolute neutrophil count	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Joint effusion	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Joint range of motion decreased: Hip	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Left chest wall pain	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Renal and urinary disorders Left pleural effusion	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Lung infection	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Malaise	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other: cold intolerance	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Muscle Cramp	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Musculoskeletal & connective tissue disorder, other, (Groin pain)	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders nasal congestion	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Nausea	34.8% 8/23 • Number of events 15 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, mycosis fungoides	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: Cutaneous Lymp	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Nervous system disorders Nervous system disorders ; other - Speech change	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Pain	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Musculoskeletal and connective tissue disorders Pain in extremity	43.5% 10/23 • Number of events 11 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Nervous system disorders Paresthesia	17.4% 4/23 • Number of events 8 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations Platelet count decreased	21.7% 5/23 • Number of events 5 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Pleural effusion	17.4% 4/23 • Number of events 4 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Productive cough	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Renal and urinary disorders Proteinuria	17.4% 4/23 • Number of events 4 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Pruritus	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Injury, poisoning and procedural complications Radiation proctitis	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Renal and urinary disorders Renal and urinary disorders - Other, specify: nocturia	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Renal and urinary disorders Renal and urinary disorders - Other, Ureteral stricture	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Renal and urinary disorders Renal and urinary disorders - Other: Hydronephrosis	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - other; Empyema	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - other; Orthopnea	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Reproductive system and breast disorders Scrotal pain	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Shortness of breath	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other: Rash	4.3% 1/23 • Number of events 1 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Gastrointestinal disorders Vomiting	21.7% 5/23 • Number of events 5 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Weight gain	26.1% 6/23 • Number of events 6 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
General disorders Weight loss	13.0% 3/23 • Number of events 3 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Respiratory, thoracic and mediastinal disorders Wheezing	17.4% 4/23 • Number of events 9 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)
Investigations White blood cell decreased	8.7% 2/23 • Number of events 2 • Adverse events collected occurring through the time period from the signing of the informed consent, through 3 years post treatment for progression or death (whichever comes first)

Additional Information

Raquibul Hannan

University Of Texas Southwestern Medical Center (Dallas, TX)

Phone: 214/645-7696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place