Trial Outcomes & Findings for rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide (NCT NCT03687957)

Last Updated: 2025-11-25

Results Overview

-The maximum tolerated dose (MTD) is defined as the dose level immediately below the non-tolerated dose. A total of at least 6 patients must be treated at a dose level for it to be considered the MTD.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Within 30 days of treatment start

Results posted on

2025-11-25

Participant Flow

The Phase II Expansion Arm never opened to enrollment and no participants were enrolled in this portion of the trial.

Participant milestones

Participant milestones
Measure	Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.	Randomized Phase II: rhIL-7-hyFc Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized Enrolled to Randomized Phase II trial portion but not randomized.
Overall Study STARTED	1	1	3	6	6	2	11	11	1
Overall Study COMPLETED	1	0	2	0	2	0	4	5	0
Overall Study NOT COMPLETED	0	1	1	6	4	2	7	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.	Randomized Phase II: rhIL-7-hyFc Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized Enrolled to Randomized Phase II trial portion but not randomized.
Overall Study Withdrawal by Subject	0	0	2	0	0	3	1	1
Overall Study Disease progression	1	1	2	2	0	2	1	0
Overall Study Physician Decision	0	0	2	1	0	1	0	0
Overall Study New malignancy	0	0	0	1	0	0	0	0
Overall Study Adverse Event	0	0	0	0	2	0	3	0
Overall Study Patient went on hospice	0	0	0	0	0	1	0	0
Overall Study Death	0	0	0	0	0	0	1	0

Baseline Characteristics

rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) n=2 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) n=1 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) n=1 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) n=3 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) n=6 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) n=6 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo n=11 Participants -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.	Randomized Phase II: rhIL-7-hyFc n=11 Participants Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized n=1 Participants Enrolled to Randomized Phase II trial portion but not randomized.	Total n=42 Participants Total of all reporting groups
Age, Continuous	34 years n=10 Participants	57 years n=45 Participants	32 years n=12929 Participants	46 years n=6349 Participants	63 years n=4548 Participants	57.5 years n=28448 Participants	58 years n=1353 Participants	61 years n=9 Participants	42 years n=6 Participants	57.5 years n=45 Participants
Sex: Female, Male Female	1 Participants n=10 Participants	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	1 Participants n=4548 Participants	3 Participants n=28448 Participants	5 Participants n=1353 Participants	4 Participants n=9 Participants	1 Participants n=6 Participants	15 Participants n=45 Participants
Sex: Female, Male Male	1 Participants n=10 Participants	1 Participants n=45 Participants	1 Participants n=12929 Participants	3 Participants n=6349 Participants	5 Participants n=4548 Participants	3 Participants n=28448 Participants	6 Participants n=1353 Participants	7 Participants n=9 Participants	0 Participants n=6 Participants	27 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants	0 Participants n=1353 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=10 Participants	1 Participants n=45 Participants	1 Participants n=12929 Participants	3 Participants n=6349 Participants	6 Participants n=4548 Participants	5 Participants n=28448 Participants	11 Participants n=1353 Participants	11 Participants n=9 Participants	1 Participants n=6 Participants	41 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	1 Participants n=28448 Participants	0 Participants n=1353 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants	0 Participants n=1353 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants	1 Participants n=1353 Participants	1 Participants n=9 Participants	0 Participants n=6 Participants	2 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants	0 Participants n=1353 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	0 Participants n=10 Participants	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants	0 Participants n=1353 Participants	1 Participants n=9 Participants	0 Participants n=6 Participants	1 Participants n=45 Participants
Race (NIH/OMB) White	2 Participants n=10 Participants	1 Participants n=45 Participants	1 Participants n=12929 Participants	3 Participants n=6349 Participants	6 Participants n=4548 Participants	6 Participants n=28448 Participants	10 Participants n=1353 Participants	9 Participants n=9 Participants	1 Participants n=6 Participants	39 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants	0 Participants n=1353 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants	0 Participants n=4548 Participants	0 Participants n=28448 Participants	0 Participants n=1353 Participants	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=45 Participants
Region of Enrollment United States	2 participants n=10 Participants	1 participants n=45 Participants	1 participants n=12929 Participants	3 participants n=6349 Participants	6 participants n=4548 Participants	6 participants n=28448 Participants	11 participants n=1353 Participants	11 participants n=9 Participants	1 participants n=6 Participants	42 participants n=45 Participants

PRIMARY outcome

Timeframe: Within 30 days of treatment start

Population: All Phase I participants are evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Randomized Phase II: rhIL-7-hyFc Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized Enrolled to Randomized Phase II trial portion but not randomized.	Phase II Expansion Arm: rhIL-7-hyFc n=19 Participants Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.
Phase I Only: Safety and Tolerability of rhIL-7-hyFc as Measured by the Maximum Tolerated Dose (MTD) of rhIL-7-hyFc	—	—	720 mcg/kg	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Within 30 days of treatment start

Population: This outcome measure is for Phase I participants only.

-DLTs are defined in the protocol.

Outcome measures

Outcome measures
Measure	Randomized Phase II: rhIL-7-hyFc Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized Enrolled to Randomized Phase II trial portion but not randomized.	Phase II Expansion Arm: rhIL-7-hyFc n=1 Participants Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) n=1 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) n=3 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) n=6 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) n=6 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) n=2 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.
Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs)	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—

PRIMARY outcome

Timeframe: Baseline to Prior to adjuvant TMZ (approximately week 4)

Population: Only participants in the Randomized Phase II Placebo and Randomized Phase II rhIL-7-hyFc are evaluable for this outcome measure.

Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.

Outcome measures

Outcome measures
Measure	Randomized Phase II: rhIL-7-hyFc n=11 Participants Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized Enrolled to Randomized Phase II trial portion but not randomized.	Phase II Expansion Arm: rhIL-7-hyFc Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo n=11 Participants -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.
Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC)	147.8261 percent change Standard Deviation 285.9597	—	—	—	—	—	—	—	16.66667 percent change Standard Deviation 28.36597

PRIMARY outcome

Timeframe: Through completion of follow-up (estimated to be 5 years and 6 months)

Population: The Phase II Expansion Arm of the trial never opened to enrollment and no participants were enrolled.

-Defined from date of surgery to date of progression or death due to disease or date of last clinical follow up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1, Week 13, Week 25, and Week 45

Population: Samples were not collected at all time points if a participant was removed from treatment or removed from the study prior to that timepoint. Week 25 was removed with amendment #4 and only one participant had a sample collected at this time point.

* The formation of anti-drug antibodies (ADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure. The data will be presented if anti-drug antibodies are detected or not detected in the samples. * Week 1 will be prior to injection of 1st dose of rhIL-7-hyFc, week 13 will be prior to the 2nd dose of rhIL-7-hyFc, and week 45 will be 8 weeks after the last dose of rhIL-7-hyFc.

Outcome measures

Outcome measures
Measure	Randomized Phase II: rhIL-7-hyFc n=11 Participants Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized Enrolled to Randomized Phase II trial portion but not randomized.	Phase II Expansion Arm: rhIL-7-hyFc n=1 Participants Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) n=1 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) n=3 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) n=6 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) n=6 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) n=2 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo n=11 Participants -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) Week 1 · Detected	1 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) Week 1 · Not Detected	10 Participants	—	1 Participants	1 Participants	3 Participants	6 Participants	5 Participants	2 Participants	9 Participants
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) Week 13 · Detected	7 Participants	—	1 Participants	1 Participants	2 Participants	2 Participants	5 Participants	0 Participants	1 Participants
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) Week 13 · Not Detected	0 Participants	—	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	6 Participants
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) Week 25 · Detected	0 Participants	—	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) Week 25 · Not Detected	0 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) Week 45 · Detected	5 Participants	—	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) Week 45 · Not Detected	0 Participants	—	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline to Prior to adjuvant TMZ (approximately week 4)

Population: Only Phase I participants are evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Randomized Phase II: rhIL-7-hyFc Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized Enrolled to Randomized Phase II trial portion but not randomized.	Phase II Expansion Arm: rhIL-7-hyFc n=1 Participants Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) n=1 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) n=3 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) n=3 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) n=6 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) n=2 Participants * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.
Phase I: Percent Change in Absolute Lymphocyte Count (ALC)	—	—	37.5 percent change Standard Deviation NA SD was not able to be calculated because data is for 1 participant	-22.222 percent change Standard Deviation NA SD was not able to be calculated because data is for 1 participant	25 percent change Standard Deviation 161.231	129.545 percent change Standard Deviation 81.696	52.083 percent change Standard Deviation 87.525	-5.639 percent change Standard Deviation 88.787	—

Adverse Events

Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 5 deaths

Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Randomized Phase II: Placebo

Serious events: 3 serious events

Other events: 9 other events

Deaths: 9 deaths

Randomized Phase II: rhIL-7-hyFc

Serious events: 4 serious events

Other events: 11 other events

Deaths: 10 deaths

Randomized Phase II: Not Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) n=1 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) n=1 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) n=3 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) n=6 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) n=6 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) n=2 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo n=11 participants at risk -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.	Randomized Phase II: rhIL-7-hyFc n=11 participants at risk Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized n=1 participants at risk Enrolled to Randomized Phase II trial portion but not randomized.
Cardiac disorders Heart failure	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Gastrointestinal disorders Diarrhea	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Fever	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Suspected neoplasm progression	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Infections and infestations COVID-19 infection	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Infections and infestations Lung infection	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Infections and infestations Urinary tract infection	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Injury, poisoning and procedural complications Car accident injuries	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Investigations Alanine aminotransferase increased	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	50.0% 1/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Headache	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Muscle weakness right-sided	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Seizure	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Stroke	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Psychiatric disorders Confusion	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.

Other adverse events

Other adverse events
Measure	Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg) n=1 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg) n=1 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg) n=3 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg) n=6 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg) n=6 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg) n=2 participants at risk * Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned * The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels	Randomized Phase II: Placebo n=11 participants at risk -Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of placebo injections are planned.	Randomized Phase II: rhIL-7-hyFc n=11 participants at risk Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.	Randomized Phase II: Not Randomized n=1 participants at risk Enrolled to Randomized Phase II trial portion but not randomized.
Ear and labyrinth disorders Hearing impaired	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Eye disorders Blurred vision	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Eye disorders Diplopia	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Gastrointestinal disorders Colitis	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Gastrointestinal disorders Constipation	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Gastrointestinal disorders Diarrhea	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Gastrointestinal disorders Fecal incontinence	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Gastrointestinal disorders Nausea	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Gastrointestinal disorders Vomiting	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	50.0% 1/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Blood and lymphatic system disorders Anemia	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Chills	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	50.0% 1/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Disease progression	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Fatigue	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	27.3% 3/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Fever	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Gait disturbance	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Injection site reaction	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	50.0% 1/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	27.3% 3/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Infections and infestations Eye infection	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Infections and infestations Sinus infection	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Infections and infestations Tooth infection	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Infections and infestations Urinary tract infection	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Injury, poisoning and procedural complications Bruising	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	33.3% 1/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Investigations Alanine aminotransferase increased	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	33.3% 2/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Investigations CD4 lymphocytes decreased	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	100.0% 3/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	33.3% 2/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Investigations Platelet count decreased	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Investigations White blood cell decreased	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Metabolism and nutrition disorders Anorexia	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	33.3% 1/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	50.0% 1/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	33.3% 2/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	50.0% 1/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Dysarthria	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Headache	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	50.0% 1/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Paresthesia	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Tremors	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Psychiatric disorders Anxiety	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Renal and urinary disorders Renal calculi	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Renal and urinary disorders Urinary incontinence	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Surgical and medical procedures Biopsy and Interstitial Laser Thermal Therapy	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	33.3% 1/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Vascular disorders Hypertension	100.0% 1/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	16.7% 1/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	50.0% 3/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	27.3% 3/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Vascular disorders Thromboembolic event	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Pain - starts in right foot and migrates to head	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Pain - right side	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Edema limbs	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Flu like symptoms	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
General disorders Pain	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Immune system disorders Allergic reaction	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Investigations Neutrophil count decreased	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Investigations Weight gain	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Investigations Weight loss	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	27.3% 3/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Muscle weakness - right-sided	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Nervous system disorders Seizure	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Psychiatric disorders Altered mental status	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Psychiatric disorders Confusion	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Psychiatric disorders Depression	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Psychiatric disorders Insomnia	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Psychiatric disorders Irritability	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Renal and urinary disorders Proteinuria	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	9.1% 1/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/3 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/6 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/2 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	18.2% 2/11 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.	0.00% 0/1 • - Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.

Additional Information

Dr. Milan Chheda

Washington University School of Medicine

Phone: 314-747-2712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place