Trial Outcomes & Findings for Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma (NCT NCT04225039)

Last Updated: 2025-08-15

Results Overview

Per modified response assessment in neuro-oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in the sum of the products of the perpendicular diameters of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

26 months

Results posted on

2025-08-15

Participant Flow

A total of 39 participants signed consent. A total of 5 participants either failed to meet eligibility requirements or withdrew consent. A total of 18 participants were assigned to Cohort A. Because of a protocol deviation, the data of 2 participants was not used for efficacy analysis, but it was used for safety. A total of 8 participants were assigned to Cohort B Sub-arm #1. A total of 8 participants were assigned to Cohort B Sub-arm #2.

Participant milestones

Participant milestones
Measure	Cohort A Subjects in this arm (N=18) receive a single priming dose of both INCMGA00012 (500mg) and INCAGN01876 (300mg) prior to stereotactic radiosurgery (SRS), then undergo SRS (8 Gy x 3 fractions). Following SRS, INCMGA00012 (500mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) are resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. Because of a protocol deviation, two subjects' data is not analyzed for efficacy. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment SRS: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy).	Cohort B Sub-arm #1 Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 (500mg) + INCAGN01876 (300mg) + SRS. Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (500 mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment SRS: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy). Brain surgery: maximal safe surgical resection of the tumor.	Cohort B Sub-arm #2 Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 + INCAGN01876 (without SRS). Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (IV every 4 weeks) and INCAGN01876 (IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment Brain surgery: maximal safe surgical resection of the tumor.	Ineligible or Withdrew Consent Subjects in this arm (N=5) signed the consent form but were either ineligible for the study or withdrew consent and were never treated
Overall Study STARTED	18	8	8	5
Overall Study COMPLETED	15	7	8	0
Overall Study NOT COMPLETED	3	1	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Subjects in this arm (N=18) receive a single priming dose of both INCMGA00012 (500mg) and INCAGN01876 (300mg) prior to stereotactic radiosurgery (SRS), then undergo SRS (8 Gy x 3 fractions). Following SRS, INCMGA00012 (500mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) are resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. Because of a protocol deviation, two subjects' data is not analyzed for efficacy. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment SRS: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy).	Cohort B Sub-arm #1 Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 (500mg) + INCAGN01876 (300mg) + SRS. Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (500 mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment SRS: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy). Brain surgery: maximal safe surgical resection of the tumor.	Ineligible or Withdrew Consent Subjects in this arm (N=5) signed the consent form but were either ineligible for the study or withdrew consent and were never treated
Overall Study Withdrawal by Subject	1	0	1
Overall Study Currently active on study treatment	0	1	0
Overall Study Protocol deviation; data not analyzed for efficacy	2	0	0
Overall Study Ineligible for treatment	0	0	4

Baseline Characteristics

Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GITR + PD1, SRS (Cohort A) n=18 Participants Subjects in this arm (N=18) receive a single priming dose of both INCMGA00012 (500mg) and INCAGN01876 (300mg) prior to stereotactic radiosurgery (SRS), then undergo SRS (8 Gy x 3 fractions). Following SRS, INCMGA00012 (500mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) are resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. Because of a protocol deviation, two subjects' data is not analyzed for efficacy. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment SRS: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy).	GITR + PD1, SRS, Surgery (Cohort B Sub-arm #1) n=8 Participants Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 (500mg) + INCAGN01876 (300mg) + SRS. Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (500 mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment SRS: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy). Brain surgery: maximal safe surgical resection of the tumor.	GITR + PD1, Surgery (Cohort B Sub-arm #2) n=8 Participants Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 + INCAGN01876 (without SRS). Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (IV every 4 weeks) and INCAGN01876 (IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment Brain surgery: maximal safe surgical resection of the tumor.	Ineligible or Withdrew Consent n=5 Participants Subjects in this arm (N=5) signed the consent form but were either ineligible for the study or withdrew consent and were never treated.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	21 Participants n=21 Participants
Age, Continuous	61 years n=5 Participants	64 years n=7 Participants	63 years n=5 Participants	67 years n=4 Participants	64 years n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	20 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	37 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	18 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	5 participants n=4 Participants	39 participants n=21 Participants

PRIMARY outcome

Timeframe: 26 months

Population: Per protocol, it was pre-specified to only include subjects in Cohort A and the subject must have received at least one dose of BOTH study drugs AND has received at least one fraction of SRS. Because of a protocol deviation, the data of 2 subjects is not included for efficacy analysis.

Outcome measures

Outcome measures
Measure	GITR + PD1, SRS (Cohort A) n=16 Participants Subjects in this arm (N=18) receive a single priming dose of both INCMGA00012 (500mg) and INCAGN01876 (300mg) prior to stereotactic radiosurgery (SRS), then undergo SRS (8 Gy x 3 fractions). Following SRS, INCMGA00012 (500mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) are resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. Because of a protocol deviation, two subjects' data is not analyzed for efficacy. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment SRS: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy).
Objective Radiographic Response (ORR)	0 % of participants with response Interval 0.0 to 19.0

SECONDARY outcome

Timeframe: 25 months

Adverse events will be evaluated by monitoring frequency, duration, and severity of adverse events (AEs) per NCI CTCAE v 5.0

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 84 months

OS, defined as the time from date of enrollment until death from any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 84 months

PFS, defined as the time from date of enrollment until the earliest date of disease progression (as determined by modified RANO criteria) or death due to any cause

Outcome measures

Outcome data not reported

Adverse Events

Cohort A

Serious events: 8 serious events

Other events: 18 other events

Deaths: 12 deaths

Cohort B Sub-arm #1

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort B Sub-arm #2

Serious events: 5 serious events

Other events: 8 other events

Deaths: 6 deaths

Ineligible or Withdrew Consent

Serious events: 1 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Regulatory Lead

University of Pennsylvania

Phone: 215-662-4484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Cohort A n=18 participants at risk Subjects in this arm (N=18) signed the consent form and received a single priming dose of both INCMGA00012 (500mg) and INCAGN01876 (300mg) prior to stereotactic radiosurgery (SRS), then undergo SRS (8 Gy x 3 fractions). Following SRS, INCMGA00012 (500mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) are resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment SRS: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy).	Cohort B Sub-arm #1 n=8 participants at risk Subjects in this arm (N=8) signed the consent form and received neoadjuvant immunotherapy INCMGA00012 (500mg) + INCAGN01876 (300mg) + SRS. Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (500 mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment SRS: administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy). Brain surgery: maximal safe surgical resection of the tumor.	Cohort B Sub-arm #2 n=8 participants at risk Subjects in this arm (N=8) signed the consent form and received neoadjuvant immunotherapy INCMGA00012 + INCAGN01876 (without SRS). Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (IV every 4 weeks) and INCAGN01876 (IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. INCMGA00012: 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment INCAGN01876: 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment Brain surgery: maximal safe surgical resection of the tumor.	Ineligible or Withdrew Consent n=5 participants at risk Subjects in this arm (N=5) signed the consent form but were either ineligible for the study or withdrew consent and were never treated.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 2/18 • Number of events 2 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Respiratory, thoracic and mediastinal disorders Other: Chest tightness	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Respiratory, thoracic and mediastinal disorders Sore throat	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Alopecia	11.1% 2/18 • Number of events 2 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Body odor	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	25.0% 2/8 • Number of events 2 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Other: Bug bites on extremities	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Other: Circular red spots	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Other: Erythematous ecchymotic rash	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Other: Milaria rubra rash	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Other: Nodule L hand	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Skin and subcutaneous tissue disorders Other: Petechiae	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Injury, poisoning and procedural complications Other: Pain, left hip, intermittent	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Blood and lymphatic system disorders Anemia	11.1% 2/18 • Number of events 3 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 2 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Blood and lymphatic system disorders Other: Enlarged lymph node	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Cardiac disorders Other: Ectopic beat	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Cardiac disorders Palpitations	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Cardiac disorders Sinus tachycardia	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Ear and labyrinth disorders Ear pain	11.1% 2/18 • Number of events 3 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Ear and labyrinth disorders Hearing impaired	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Ear and labyrinth disorders Other: Ear fullness	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Ear and labyrinth disorders Other: Whooshing sound in ears	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 2 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Ear and labyrinth disorders Tinnitus	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Ear and labyrinth disorders Vertigo	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 2 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Endocrine disorders Cushingoid	11.1% 2/18 • Number of events 2 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Eye disorders Blurred vision	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Eye disorders Extraocular muscle paresis	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Eye disorders Eye pain	11.1% 2/18 • Number of events 2 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Eye disorders Floaters	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Eye disorders Other: Allergies	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Eye disorders Other: Change in vision, non-specific, not blurring not diplopia	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Eye disorders Other: Decreased ROM	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Eye disorders Other: Double vision	5.6% 1/18 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.
Eye disorders Periorbital edema	0.00% 0/18 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	12.5% 1/8 • Number of events 1 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/8 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.	0.00% 0/5 • 26 months All subjects who sign informed consent will be included in safety analyses and in calculation of the rate of AEs, regardless of whether and how much study drug was received. Subjects who were determined to be ineligible for treatment or who withdrew consent and did not receive treatment are included in the safety analyses, in the "Ineligible or Withdrew Consent" cohort.