Trial Outcomes & Findings for Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS Cancers (NCT NCT03173950)

Last Updated: 2026-08-18

Results Overview

Disease control rate (DCR) measured in a variety of recurrent refractory primary central nervous system tumors. DCR is defined as a confirmed CR/PR or durable stable disease (SD) for 6 months assessed by the Immunotherapy Response Assessment Neuro-Oncology (iRANO) criteria. Complete Response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial Response is ≥ 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Durable stable disease does not qualify for CR, PR or progression (\>25% increase in the sum of the products of perpendicular diameters of enhancing lesions (over best response \[smallest tumor size\] or baseline if no decrease) on stable or increasing doses of corticosteroids. A single value was calculated (e.g. summed or averaged) by

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

136 participants

Primary outcome timeframe

From cycle one Day 1 of the treatment through the end of treatment, up to 64 weeks

Results posted on

2026-08-18

Participant Flow

All participants enrolled who have data collected are reported.

Participant milestones

Participant milestones
Measure	Cohort 1- Heavily Pre-Treated Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Overall Study STARTED	76	30	30
Overall Study Lost to further follow-up	2	3	0
Overall Study Refused further follow-up	1	2	0
Overall Study Completed treatment phase but refused the protocol specified follow-up	1	0	0
Overall Study Death during follow-up period	39	9	0
Overall Study COMPLETED	42	14	0
Overall Study NOT COMPLETED	34	16	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1- Heavily Pre-Treated Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Overall Study Ineligible	0	0	19
Overall Study Pursuing other treatment	0	0	1
Overall Study Participant declined to participate (before treatment started).	0	1	9
Overall Study Refused further treatment	1	1	0
Overall Study Physician Decision	12	7	0
Overall Study National Cancer Institute and principal investigator discretion	0	1	0
Overall Study Study closure/termination	15	5	0
Overall Study Death on Study	3	1	0
Overall Study Withdrew informed consent form and decided not to participate	0	0	1
Overall Study Did not complete a minimum of one cycle of treatment	3	0	0

Baseline Characteristics

Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1- Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=30 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles n=30 Participants Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=298 Participants	0 Participants n=102 Participants	0 Participants n=400 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=298 Participants	23 Participants n=102 Participants	24 Participants n=400 Participants	112 Participants n=30 Participants
Age, Categorical >=65 years	11 Participants n=298 Participants	7 Participants n=102 Participants	6 Participants n=400 Participants	24 Participants n=30 Participants
Age, Continuous	47.42 years STANDARD_DEVIATION 15.93 • n=298 Participants	53.07 years STANDARD_DEVIATION 17.01 • n=102 Participants	49.77 years STANDARD_DEVIATION 16.15 • n=400 Participants	49.18 years STANDARD_DEVIATION 16.26 • n=30 Participants
Sex: Female, Male Female	37 Participants n=298 Participants	9 Participants n=102 Participants	14 Participants n=400 Participants	60 Participants n=30 Participants
Sex: Female, Male Male	39 Participants n=298 Participants	21 Participants n=102 Participants	16 Participants n=400 Participants	76 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=298 Participants	4 Participants n=102 Participants	2 Participants n=400 Participants	22 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=298 Participants	25 Participants n=102 Participants	28 Participants n=400 Participants	112 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=298 Participants	1 Participants n=102 Participants	0 Participants n=400 Participants	2 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=298 Participants	1 Participants n=102 Participants	0 Participants n=400 Participants	2 Participants n=30 Participants
Race (NIH/OMB) Asian	5 Participants n=298 Participants	1 Participants n=102 Participants	2 Participants n=400 Participants	8 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=298 Participants	1 Participants n=102 Participants	0 Participants n=400 Participants	1 Participants n=30 Participants
Race (NIH/OMB) Black or African American	5 Participants n=298 Participants	1 Participants n=102 Participants	3 Participants n=400 Participants	9 Participants n=30 Participants
Race (NIH/OMB) White	60 Participants n=298 Participants	23 Participants n=102 Participants	24 Participants n=400 Participants	107 Participants n=30 Participants
Race (NIH/OMB) More than one race	1 Participants n=298 Participants	0 Participants n=102 Participants	1 Participants n=400 Participants	2 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=298 Participants	3 Participants n=102 Participants	0 Participants n=400 Participants	7 Participants n=30 Participants
Region of Enrollment United States	76 participants n=298 Participants	30 participants n=102 Participants	30 participants n=400 Participants	136 participants n=30 Participants

PRIMARY outcome

Timeframe: From cycle one Day 1 of the treatment through the end of treatment, up to 64 weeks

Population: 102/136 participants were analyzed because 19 participants were ineligible, 1 pursued other treatment, 1 withdrew consent and decided not to participate, 9 declined to participate before treatment started (after consent) ,1 withdrew consent and decided not to participate in cohort 2 and 3 did not complete a minimum of one cycle in cohort 1.

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=73 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=29 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Disease Control Rate (Complete Response (CR) + Partial Response (PR) or Durable Stable Disease (SD) for 6 Months Measured in a Variety of Recurrent Refractory Primary Central Nervous System Tumors Reported With Standard Deviation	0.219 Proportion of participants Standard Deviation 0.048	0.379 Proportion of participants Standard Deviation 0.09	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From cycle one Day 1 of the treatment through the end of the treatment, up to 64 weeks

Disease control rate (DCR) measured in a variety of recurrent refractory primary central nervous system tumors. DCR is defined as a confirmed CR/PR or durable stable disease (SD) for 6 months assessed by the Immunotherapy Response Assessment Neuro-Oncology (iRANO) criteria. Complete Response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial Response is ≥ 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Durable stable disease does not qualify for CR, PR or progression (i.e., \>25% increase in the sum of the products of perpendicular diameters of enhancing lesions (over best response \[smallest tumor size\] or baseline if no decrease) on stable or increasing doses of corticosteroids. A single value was calculated (e.g. summed or averaged) by

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=73 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=29 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Disease Control Rate (Complete Response (CR) + Partial Response (PR) or Durable Stable Disease (SD) for 6 Months Measured in a Variety of Recurrent Refractory Primary Central Nervous System Tumors Reported With a 95% Confidence Interval	21.9 percentage of participants Interval 13.1 to 33.1	37.9 percentage of participants Interval 20.7 to 57.7	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From cycle one Day 1 of the treatment through the end of the treatment, up to 64 weeks

Population: 105/136 participants were analyzed because 19 participants were ineligible, 1 pursued other treatment, 2 withdrew consent and decided not to participate, and 9 declined to participate before treatment started (after consent).

PFS is defined as the date of on-study to the date of disease progression or death, estimated with the Kaplan-Meier method and reported with a 95% confidence interval. Response was assessed by the Immunotherapy Response Assessment Neuro-Oncology (iRANO) criteria and estimated using the Kaplan-Meier method. Progressive Disease is \>25% increase in sum of the products of perpendicular diameters of enhancing lesions (over best response \[smallest tumor size\] or baseline if no decrease) on stable or increasing doses of corticosteroids.

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=29 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Progression Free Survival (PFS)	56.5 Days Interval 55.0 to 111.0	133 Days Interval 110.0 to 223.0	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 months after the initiation of treatment, up to 24 weeks

PFS-6 is the rate of durable Stable Disease lasting at least 6 months defined from the day of study entry until imaging is confirmed to show disease progression reported with a 95% confidence interval based on the Brookmeyer-Crowley method. Response was assessed by the Immunotherapy Response Assessment Neuro-Oncology (iRANO) criteria and estimated using the Kaplan-Meier method. Progressive Disease is \>25% increase in sum of the products of perpendicular diameters of enhancing lesions (over best response \[smallest tumor size\] or baseline if no decrease) on stable or increasing doses of corticosteroids.

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=73 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=29 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Progression Free Survival at 6 Months With 95% Confidence Interval	21.9 Percentage of participants Interval 13.1 to 33.1	37.9 Percentage of participants Interval 20.7 to 57.7	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Time from the study entry and after initiation of nivolumab to participants death, up to 5 years

OS is defined as the date of on-study to the date of death from any cause or last follow up, estimated with the Kaplan-Meier method and reported with a 95% confidence interval based on the Brookmeyer-Crowley method.

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=29 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Overall Survival (OS)	1.62 years Interval 1.05 to 3.42	3.47 years Interval 2.15 to The upper bound of 95% confidence interval is not estimable due to heavy censoring at the end of study.	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Up to 14 days prior to treatment), and at time of imaging - cycle 2, 4, 6, 8, 10, and 12 (one cycle = 4 weeks)

Population: The Number Analyzed for symptom severity and interference reflects the number of participants who reached that timepoint and had a completed MDASI-BT/MDASI-SP for that timepoint. Overall Number of Participants Analyzed reflects the total number of participants in Cohort 1 and Cohort 2, respectively. 0/30 participants analyzed in last Group:19 ineligible,1 pursued other treatment,1 withdrew consent/did not participate, and 9 declined to participate before treatment started (after consent).

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles n=30 Participants Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference n=30 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With a 95% Confidence Interval, at Each Time Point Baseline (Up to 14 days prior to treatment)	1.94 score on a scale Interval 1.53 to 2.34	2.92 score on a scale Interval 2.31 to 3.54	2.06 score on a scale Interval 1.145 to 2.68	3.63 score on a scale Interval 2.51 to 4.75	—	—	—	—	—	—	—
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With a 95% Confidence Interval, at Each Time Point Cycle 2	2.16 score on a scale Interval 1.66 to 2.65	2.89 score on a scale Interval 2.12 to 3.66	1.50 score on a scale Interval 1.1 to 1.9	2.38 score on a scale Interval 1.28 to 3.47	—	—	—	—	—	—	—
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With a 95% Confidence Interval, at Each Time Point Cycle 4	2.04 score on a scale Interval 1.52 to 2.56	3.25 score on a scale Interval 2.3 to 4.2	1.50 score on a scale Interval 0.86 to 2.13	2.87 score on a scale Interval 1.36 to 4.39	—	—	—	—	—	—	—
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With a 95% Confidence Interval, at Each Time Point Cycle 6	1.36 score on a scale Interval 0.96 to 1.77	1.52 score on a scale Interval 0.82 to 2.22	0.88 score on a scale Interval 0.3 to 1.46	1.17 score on a scale Interval 0.11 to 2.23	—	—	—	—	—	—	—
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With a 95% Confidence Interval, at Each Time Point Cycle 8	1.36 score on a scale Interval 0.86 to 1.86	1.3 score on a scale Interval 0.57 to 2.04	1.14 score on a scale Interval 0.38 to 1.91	1.78 score on a scale Interval 0.4 to 3.16	—	—	—	—	—	—	—
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With a 95% Confidence Interval, at Each Time Point Cycle 10	1.39 score on a scale Interval 0.46 to 2.33	2.19 score on a scale Interval 0.68 to 3.71	0.96 score on a scale Interval -0.04 to 1.97	1.03 score on a scale Interval 0.17 to 1.9	—	—	—	—	—	—	—
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With a 95% Confidence Interval, at Each Time Point Cycle 12	0.88 score on a scale Interval 0.15 to 1.61	1.47 score on a scale Interval 0.4 to 2.53	0.72 score on a scale Interval 0.18 to 1.25	1.3 score on a scale Interval -0.09 to 2.69	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (up to 14 days prior to treatment), and at time of imaging - cycle 2, 4, 6, 8, 10, or 12 (one cycle = 4 weeks)

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles n=30 Participants Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference n=30 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Mean Symptom Burden Severity & Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) & MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With Standard Deviation(SD) at Each Time Point Baseline (up to 14 days prior to treatment)	1.94 score on a scale Standard Deviation 1.80	2.92 score on a scale Standard Deviation 2.72	2.06 score on a scale Standard Deviation 1.59	3.63 score on a scale Standard Deviation 2.91	—	—	—	—	—	—	—
Mean Symptom Burden Severity & Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) & MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With Standard Deviation(SD) at Each Time Point Cycle 2	2.16 score on a scale Standard Deviation 1.79	2.89 score on a scale Standard Deviation 2.81	1.50 score on a scale Standard Deviation 1.00	2.38 score on a scale Standard Deviation 2.73	—	—	—	—	—	—	—
Mean Symptom Burden Severity & Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) & MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With Standard Deviation(SD) at Each Time Point Cycle 4	2.04 score on a scale Standard Deviation 1.39	3.25 score on a scale Standard Deviation 2.52	1.50 score on a scale Standard Deviation 1.30	2.87 score on a scale Standard Deviation 3.09	—	—	—	—	—	—	—
Mean Symptom Burden Severity & Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) & MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With Standard Deviation(SD) at Each Time Point Cycle 6	1.36 score on a scale Standard Deviation 0.72	1.52 score on a scale Standard Deviation 1.23	0.88 score on a scale Standard Deviation 0.98	1.17 score on a scale Standard Deviation 1.79	—	—	—	—	—	—	—
Mean Symptom Burden Severity & Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) & MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With Standard Deviation(SD) at Each Time Point Cycle 8	1.36 score on a scale Standard Deviation 0.76	1.3 score on a scale Standard Deviation 1.13	1.14 score on a scale Standard Deviation 1.17	1.78 score on a scale Standard Deviation 2.11	—	—	—	—	—	—	—
Mean Symptom Burden Severity & Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) & MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With Standard Deviation(SD) at Each Time Point Cycle 10	1.39 score on a scale Standard Deviation 1.06	2.19 score on a scale Standard Deviation 1.73	0.96 score on a scale Standard Deviation 1.14	1.03 score on a scale Standard Deviation 0.99	—	—	—	—	—	—	—
Mean Symptom Burden Severity & Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) & MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Reported With Standard Deviation(SD) at Each Time Point Cycle 12	0.88 score on a scale Standard Deviation 0.74	1.47 score on a scale Standard Deviation 1.09	0.72 score on a scale Standard Deviation 0.61	1.3 score on a scale Standard Deviation 1.58	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Two possible timepoints dependent on response status. Non-responders: determined by whether disease progression occurred prior to or at cycle 6 or not. Responders: cycle 6. One cycle= 4 weeks/participants who did not have disease progression by cycle 6.

Symptom burden is composed of severity and interference as measured by the MD Anderson Symptom Inventory-Brain tumor (MDASI-BT) or MD Anderson Symptom Inventory-Spine Tumor. The MDASI-BT questionnaire contains 23 symptoms and 6 interference items. The MDASI-SP questionnaire contains 19 symptoms and 6 interference items. Symptom severity is the Mean of the 23 or 19 symptoms and ranges from 0 to 10. Higher scores indicate. Symptom interference is the Mean of the 6 interference items and ranges from 0 to 10. Higher scores indicate worse symptoms or worse interference. Response status was determined by whether disease progression occurred prior to or at cycle 6 or not. Participants who had disease progression prior to or at cycle 6 were non-responders and participants who did not have disease progression by cycle 6 were responders. Relevant MDASI-BT \& MDASI-SP data are those that correspond to the cycle where response status was determined. It is a unique cycle for each participant.

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=13 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=63 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles n=9 Participants Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference n=17 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Between Responders and Non-responders Reported With 95% Confidence Interval Symptom severity	1.61 score on a scale Interval 0.86 to 2.36	2.19 score on a scale Interval 1.74 to 2.64	1.08 score on a scale Interval 0.45 to 1.7	1.91 score on a scale Interval 1.22 to 2.61	—	—	—	—	—	—	—
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Between Responders and Non-responders Reported With 95% Confidence Interval Symptom interference	2.12 score on a scale Interval 1.04 to 3.2	3.19 score on a scale Interval 2.49 to 3.9	1.68 score on a scale Interval 0.32 to 3.03	3.39 score on a scale Interval 1.96 to 4.82	—	—	—	—	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=13 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=63 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles n=9 Participants Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference n=17 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Between Responders and Non-responders Reported With Standard Deviation Symptom severity	1.61 score on a scale Standard Deviation 1.10	2.19 score on a scale Standard Deviation 1.74	1.08 score on a scale Standard Deviation 0.96	1.91 score on a scale Standard Deviation 1.33	—	—	—	—	—	—	—
Mean Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Between Responders and Non-responders Reported With Standard Deviation Symptom interference	2.12 score on a scale Standard Deviation 1.86	3.19 score on a scale Standard Deviation 2.54	1.68 score on a scale Standard Deviation 1.77	3.39 score on a scale Standard Deviation 2.78	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Between Baseline (up to 14 days prior to treatment) and at time of imaging - cycle 2, 4, 6, 8, 10, and 12 (one cycle = 4 weeks)

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=51 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=51 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles n=24 Participants Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference n=24 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Mean Change Scores in Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Between Baseline and Even-numbered Cycle Baseline to Cycle 2	0.22 score on a scale Interval -0.11 to 0.55	0.07 score on a scale Interval -0.51 to 0.64	-0.37 score on a scale Interval -0.79 to 0.05	-1.14 score on a scale Interval -2.28 to -0.01	—	—	—	—	—	—	—
Mean Change Scores in Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Between Baseline and Even-numbered Cycle Baseline to Cycle 4	0.34 score on a scale Interval -0.14 to 0.83	0.76 score on a scale Interval -0.2 to 1.72	-0.06 score on a scale Interval -0.67 to 0.54	0.06 score on a scale Interval -1.5 to 1.63	—	—	—	—	—	—	—
Mean Change Scores in Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Between Baseline and Even-numbered Cycle Baseline to Cycle 6	0.08 score on a scale Interval -0.21 to 0.38	-0.52 score on a scale Interval -1.61 to 0.57	-0.41 score on a scale Interval -0.81 to -0.02	-1.56 score on a scale Interval -2.91 to -0.21	—	—	—	—	—	—	—
Mean Change Scores in Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Between Baseline and Even-numbered Cycle Baseline to Cycle 8	0.11 score on a scale Interval -0.37 to 0.59	-0.56 score on a scale Interval -1.45 to 0.32	-0.26 score on a scale Interval -0.89 to 0.36	-1.06 score on a scale Interval -2.24 to 0.13	—	—	—	—	—	—	—
Mean Change Scores in Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Between Baseline and Even-numbered Cycle Baseline to Cycle 10	-0.07 score on a scale Interval -0.64 to 0.49	-0.12 score on a scale Interval -1.25 to 1.01	-0.15 score on a scale Interval -1.25 to 0.96	-1.93 score on a scale Interval -4.24 to 0.37	—	—	—	—	—	—	—
Mean Change Scores in Symptom Burden Severity and Interference Using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and MD Anderson Symptom Inventory-Spine Tumor (MDASI-SP) Module Between Baseline and Even-numbered Cycle Baseline to Cycle 12	-0.44 score on a scale Interval -1.14 to 0.26	-0.33 score on a scale Interval -1.65 to 0.98	-0.39 score on a scale Interval -1.0 to 0.21	-1.67 score on a scale Interval -4.16 to 0.82	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Adverse Events were monitored/assessed from the first study intervention, Study Day 1 through 100 days after the study agent was last administered, up to 5 years

Population: A total of 106/136 participants were analyzed. 0/30 participants were analyzed in the "Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles" Arm/Group because 19 were ineligible,1 pursued other treatment,1 withdrew consent/did not participate, and 9 declined to participate before treatment started (after consent).

Here is the number of Grade 1, 2, 3, 4, and/or 5 serious and/or non-serious adverse events and type assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles n=76 Participants Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles n=76 Participants Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 n=30 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 n=30 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 n=30 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 n=30 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 n=30 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Cough	5 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Constipation	9 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Depression	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Diarrhea	11 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	10 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Dizziness	3 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	4 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Abdominal pain	1 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Abducens nerve disorder	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Adrenal insufficiency	6 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	5 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Agitation	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Alanine aminotransferase increased	10 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	4 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Alkaline phosphatase increased	9 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Arthralgia	6 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Confusion	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	5 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Depressed level of consciousness	1 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Dry mouth	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Wound dehiscence	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Intracranial hemorrhage	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Allergic rhinitis	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Aspartate aminotransferase increased	10 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Ataxia	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Back pain	4 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	4 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Blood bilirubin increased	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Blood lactate dehydrogenase increased	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Blurred vision	2 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Cardiac disorders - Other, specify: Chest heaviness	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Chest pain - cardiac	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Chills	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Cholesterol high	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Concentration impairment	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Conjunctivitis	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Dysphagia	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Dysphasia	2 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Dyspnea	2 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Dysuria	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Ear and labyrinth disorders - Other, specify: Hearing Issues	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Edema limbs	5 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Epistaxis	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Eye disorders - Other, specify: Left eye redness	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Eye disorders - Other, specify: Right homonymous hemianopsia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Eye disorders - Other, specify: Subconjunctival hemorrhage	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Eye disorders - Other, specify: eyes are swelling	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Facial muscle weakness	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Facial nerve disorder	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Fall	14 adverse events	5 adverse events	0 adverse events	0 adverse events	0 adverse events	8 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Fatigue	19 adverse events	10 adverse events	1 adverse events	0 adverse events	0 adverse events	13 adverse events	4 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Fever	6 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Flank pain	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Floaters	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Flushing	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Fracture	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Gait disturbance	5 adverse events	5 adverse events	3 adverse events	0 adverse events	0 adverse events	5 adverse events	4 adverse events	3 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Gastrointestinal disorders - Other, specify: Gastrointestinal virus	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Gastrointestinal pain	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - General disorders and administration site conditions - Other, specify: Joint pain	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Generalized muscle weakness	2 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Headache	17 adverse events	9 adverse events	1 adverse events	0 adverse events	0 adverse events	8 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hearing impaired	2 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hematoma	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hemoglobin increased	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hepatobiliary disorders - Other, specify: Cholelithiasis	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hiccups	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hoarseness	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hot flashes	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypercalcemia	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hyperglycemia	12 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	10 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hyperkalemia	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypernatremia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypertension	9 adverse events	6 adverse events	3 adverse events	0 adverse events	0 adverse events	11 adverse events	6 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hyperthyroidism	7 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypertriglyceridemia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypocalcemia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypoglycemia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypokalemia	4 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hyponatremia	2 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	10 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Somnolence	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Spasticity	1 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Thyroid stimulating hormone increased	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Tinnitus	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Tremor	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Urinary frequency	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Urinary incontinence	5 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Urinary retention	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Urine discoloration	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Ventricular arrhythmia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Vertigo	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Voice alteration	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Vomiting	8 adverse events	6 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Weight gain	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Weight loss	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious White blood cell decreased	23 adverse events	10 adverse events	2 adverse events	0 adverse events	0 adverse events	6 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Allergic reaction	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Aspiration	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Burn	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Buttock pain	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious CD4 lymphocytes decreased	2 adverse events	2 adverse events	5 adverse events	0 adverse events	0 adverse events	5 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Cataract	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Cognitive disturbance	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Colitis	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Dehydration	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Dry eye	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Dysarthria	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Ear and labyrinth disorders - Other, specify: Left ear drainage	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Eye disorders - Other, specify: Diplopia	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Eye pain	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Eyelid function disorder	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Flu like symptoms	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Gastroesophageal reflux disease	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Infections and infestations - Other, specify: FLU	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Infections and infestations - Other, specify: Thrush	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Infections and infestations - Other, specify: Urinary Tract Infection	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Infusion related reaction	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Infusion site extravasation	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Injury, poisoning and procedural complications - Other, specify: Incisional drainage	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Investigations - Other, specify: Low iron	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Metabolism and nutrition disorders - Other, specify: Low iron	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Musculoskeletal and connective tissue disorder - Other, specify: Left jaw pain	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	2 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nervous system disorders - Other, specify: Facial Muscle Weakness (Left)	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Vomiting	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Alopecia	2 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Anal hemorrhage	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Anemia	13 adverse events	10 adverse events	4 adverse events	0 adverse events	0 adverse events	5 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Anorexia	2 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Anxiety	1 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypophosphatemia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypotension	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Hypothyroidism	5 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	6 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Infections and infestations - Other, specify: COVID	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Infections and infestations - Other, specify:COVID-19	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Infections and infestations - Other, specify: RSV positive	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Infections and infestations - Other, specify: Right ear infection	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Infections and infestations - Other, specify: Hidradenitis suppurative in groin area	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Infections and infestations - Other, specify: positive for COVID-19	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Insomnia	8 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	7 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Investigations - Other, specify: Creatinine	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Investigations - Other, specify: Increased TSH	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Investigations - Other, specify: Thyroid stimulating hormone increased	4 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Irregular menstruation	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Irritability	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Lethargy	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Localized edema	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Lymphocyte count decreased	25 adverse events	18 adverse events	8 adverse events	0 adverse events	0 adverse events	14 adverse events	4 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Malaise	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Memory impairment	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Metabolism and nutrition disorders - Other, specify: diabetic ketoacidosis	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Mucositis oral	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Muscle cramp	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Muscle weakness left-sided	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Muscle weakness lower-limb	2 adverse events	5 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Muscle weakness right-sided	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Muscle weakness upper limb	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Musculoskeletal and connective tissue disorder - Other, specify: Muscle cramp/spasm	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Myalgia	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nausea	11 adverse events	6 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Neck pain	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Neoplasms benign, malignant&unspecified Bx Parotid lesion;confirmed basal cell carcinoma	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Neoplasms benign, malignant and unspecified(cysts&polyps) Epidermal Inclusion Cyst (EIC)	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Neoplasms benign, malignant & unspecified (incl cysts &polyps)Other, specify:Lung Nodule	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nervous system disorders - Other, specify: Mild receptive aphasia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	00 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nervous system disorders - Other, specify: R hemisensory loss	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nervous system disorders - Other, specify: Subtle frontal Release	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nervous system disorders - Other, specify: dysesthesia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Neutrophil count decreased	7 adverse events	10 adverse events	2 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Non-cardiac chest pain	2 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Pain	18 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Pain in extremity	2 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Paresthesia	8 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	5 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Peripheral motor neuropathy	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Pharyngolaryngeal pain	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Platelet count decreased	15 adverse events	0 adverse events	00 adverse events	0 adverse events	0 adverse events	7 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Pruritus	10 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	8 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Rash acneiform	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Rash maculo-papular	9 adverse events	3 adverse events	1 adverse events	0 adverse events	0 adverse events	3 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Renal and urinary disorders - Other, specify: Urine Odor	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Respiratory, thoracic and mediastinal disorders - Other, specify: Bronchiolitis	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Respiratory,thoracic&mediastinal disordersOther,specifySome dry throat for past~ 3weeks	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Seizure	3 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Sinus bradycardia	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	4 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Sinus tachycardia	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: FACE, INTERMITTENT SINCE 1994	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: Face Rash	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: Felt Clammy	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: Left scalp lesion	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: R hand rash	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: On Ankles	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: RASH ABD/CHEST/BACK	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin & subcutaneous tissue disorders/Other, specify:Rash, lower extremities, knees/below	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin induration	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin infection	2 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nervous system disorders - Other, specify: Intermittent worsening of R hemisensory loss	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nervous system disorders - Other, specify: Neuropathic back pain	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nervous system disorders - Other, specify: R SIDE LACK OF COORDINATION	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Oral pain	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Papilledema	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Peripheral sensory neuropathy	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Presyncope	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Productive cough	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Respiratory, thoracic and mediastinal disorders - Other, specify: Covid 19	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Sinusitis	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Stroke	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: Dermatitis	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: blister, right 1st toe	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Surgical and medical procedures - Other, specify: Scalp Revision Surgery	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Surgical and medical procedures - Other, specify: outpatient debridement - scalp wound	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Thromboembolic event	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Upper respiratory infection	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Urinary tract infection	0 adverse events	10 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Urinary urgency	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Dry skin	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Dysesthesia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Facial pain	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Anemia	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Vestibular disorder	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Gastrointestinal disorders - Other, specify: perforated cecum	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Creatinine increased	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	6 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Intracranial hemorrhage	0 adverse events	1 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Myocardial infarction	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign,malignant &unspecified(incl cysts&polyps)- Atypical Teratoid Rhabdoid Tumor	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign, malignant & unspecified (incl cysts & polyps)Other: Diffuse midline glioma	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Nausea	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign, malignant&unspecified (incl cysts&polyps)Other,specify:Disease progression	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Hydrocephalus	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign, malignant & unspecified (incl cysts & polyps) -Other, specify: Gliosarcoma	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Tumor hemorrhage	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign, malignant & unspecified (incl cysts &polyps) - Other, MALIGNANT MENINGIOMA	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Urinary incontinence	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign, malignant&unspecified (incl cysts&polyps) - Other, specify:MEDULLOBLASTOMA	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign, malignant & unspecified (incl cysts&polyps) -Other, specify:MIDLINE GLIOMA	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Urinary tract infection	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign,malignant&unspecified (incl cysts&polyps)Other:PAPILLARY TUMOR PINEAL GLAND	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Alanine aminotransferase increased	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Appendicitis perforated	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign, malignant&unspecified (incl cysts/polyps)Other,specify:PROGRESSIVE DISEASE	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Confusion	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Dehydration	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Dysphagia	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Edema cerebral	0 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Encephalopathy	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Eye disorders - Other, specify: vision decreased	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Eye Disorders - Other, specify: Central Retinal Vein Occlusion - Left Eye	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Hypoxia	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Facial pain	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Fall	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Fatigue	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Injury, poisoning and procedural complications - Other, specify: Bee sting	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Fracture	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious General disorders and administration site conditions - Other, specify: Aphasia	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious General disorders and administration site conditions - Other, specify: Disease Progression	0 adverse events	0 adverse events	10 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious General disorders and administration site conditions - Other, specify: Encephalopathy	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious General disorders &administration site conditions - Other, specify: Treatment effect/changes	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Hematoma	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Hydrocephalus	0 adverse events	0 adverse events	3 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Hyperglycemia	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Infections and infestations - Other, specify: GI VIRAL INFECTION	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Metabolism and nutrition disorders - Other, specify: Failure to thrive	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Muscle weakness lower limb	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign,malignant&unspecified(incl cysts & polyps)-Prominent lymphocytic infiltrate	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign,malignant&unspecified (incl cysts&polyps)-Tumor debulking (tumor resection)	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Pain	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Paresthesia	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Respiratory, thoracic and mediastinal disorders -Other, specify: Immune mediated pneumonitis	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Skin infection	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Surgical and medical procedures - Other, specify: Craniotomy	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Surgical and medical procedures - Other, specify: Incisional drainage	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Surgical and medical procedures - Other, specify: Laminectomy	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nasal congestion	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Surgical and medical procedures - Other, specify: Resection-Parotid gland tumor	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Thrush	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Edema cerebral	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Eye Disorders - Other, Specify: Hemianopsias (LEFT)	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Nervous System Disorders - Other, specify: Neuropathic abdominal pain	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Musculoskeletal and connective tissue disorder - Other, specify: muscle spasm/cramp	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Ear pain	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Skin and subcutaneous tissue disorders - Other, specify: Rash papular	1 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious - Investigations - Other, specify:Thyroid stimulating hormone increased	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Non-Serious Urinary tract obstruction	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Surgical and medical procedures - Other, specify: Tumor resection	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Surgical and medical procedures - Other, specify: surgical resection	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Thromboembolic event	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Tumor pain	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Wound dehiscence	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Infections and infestations - Other, specify: Aspiration Pneumonia	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Blurred vision	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Chest pain - cardiac	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Cognitive disturbance	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Colitis	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Flu-like symptoms	0 adverse events	1 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Generalized muscle weakness	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Headache	0 adverse events	1 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Platelet count decreased	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Sepsis	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Injury, poisoning and procedural complications - Other, specify: Posterior Fossa Hemorrhage	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Lung infection	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify: ATRT	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	—
Number of Grades 1, 2, 3, 4, and/or 5 Treatment Related Serious and/or Non-serious Adverse Events and Type Serious Seizure	1 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Adverse Events were monitored/assessed from the first study intervention, Study Day 1 through 100 days after the study agent was last administered, up to 5 years

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Cohort 1- Heavily Pre-Treated n=76 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with 3 or more prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated n=30 Participants Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Symptom Interference Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.	Cohort 2 - Non-Heavily Pre-Treated: Grade 1 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 2 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 3 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 4 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Cohort 2 - Non-Heavily Pre-Treated: Grade 5 Arm 1/Experimental Therapy - Nivolumab Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Nivolumab: Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses. Participants with up to 2 prior therapies (radiotherapy and/or standard or investigational antineoplastic drugs).	Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles Participants were enrolled but were not treated or completed treatment cycles. Participants were not assigned to Arm/Cohorts.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	76 Participants	30 Participants	—	—	—	—	—	—	—	—	—

Adverse Events

Cohort 1- Heavily Pre-Treated

Serious events: 43 serious events

Other events: 70 other events

Deaths: 42 deaths

Cohort 2 - Non-Heavily Pre-Treated

Serious events: 13 serious events

Other events: 29 other events

Deaths: 10 deaths

Participants Enrolled Who Were Not Treated OR Completed Treatment Cycles

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Jing Wu

National Cancer Institute

Phone: 240-760-6036

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place