Trial Outcomes & Findings for Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations (NCT NCT03842228)

Last Updated: 2025-10-14

Results Overview

A DLT was evaluated according to the NCI CTCAE 5.0. An AE was defined as DLT if it met any of the following events: any grade 5 toxicity; any grade 2 toxicity that require permanent discontinuation of durvalumab or combination therapies within the first 4 weeks; grade 4 neutropenia; febrile neutropenia; neutropenic infection; grade ≥ 3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; Grade 4 anemia; non-hematological grade ≥ 4 toxicities; confirmation of QTc prolongation; grade ≥3 AE hyperglycemia or hypertension lasting \< 7 days; grade 3 skin rash despite optimal medical intervention; grade 3 diarrhea despite optimal medical intervention; any toxicity greater than baseline \& clinically significant or unacceptable \& disrupts dosing for more than 14 days; any event, including significant dose reductions or omissions as judged by safety review committee; \& any toxicity in any course of treatment that in the opinion of the investigators and medical monitors is dose-limiting.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

39 participants

Primary outcome timeframe

The DLT monitoring time frame was Cycle 1 through Cycle 2 Day 1 for the doublet combination (SIL1, SIL2, SIL3, and SIL3A) , and Cycle 1 through Cycle 3 Day 1 for the triplet combination (S2L1)

Results posted on

2025-10-14

Participant Flow

Phase Ib multicenter study led by MD Anderson Cancer Center. Participants were eligible if they had (1) advanced solid tumors for which curative measures did not exist or were no longer effective and (2) an actionable mutation in DNA Damage Response (DDR) genes (BARD1, BRCA1,BRCA2, BRIP1, FANCA, NBN, PALB2, RAD51, RAD51B, RAD51C, RAD51D), PTEN, or PIK3CA hotspots (E542, E545, or H1047).

Patients were enrolled into the following cohorts: Step 1 (Copanlisib and Olaparib dose escalation), Step 2 (Copanlisib, Olaparib, and Durvalumab dose escalation), or Step 3 (Copanlisib and Olaparib dose expansion). Patients enrolled in Step 3 were enrolled in the following dose expansion sub-cohorts: (1) those with germline or somatic DDR mutations (the DDR arm) or (2) those with PIK3CA or PTEN mutations (PIK3CA/PTEN arm). Thirty-nine patients were treated in Steps 1 - 3.

Participant milestones

Participant milestones
Measure	Step 1 Dose Level 1 Step 1 DL1: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 200 mg PO BID; 28-day cycle	Step 1 Dose Level 2 Step 1 DL2: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3 Step 1 DL3: Copanlisib 60 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3A Step 1 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 2 Dose Level 1 Step 2 DL1: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID + Durvalumab 1500 mg IV on day 1 starting at C2D1 ; 28-day cycle"	Step 3 DDR Arm Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 3 PIK3CA/PTEN Arm Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle
Overall Study STARTED	9	3	10	6	4	2	5
Overall Study COMPLETED	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	9	3	10	6	4	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Step 1 Dose Level 1 Step 1 DL1: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 200 mg PO BID; 28-day cycle	Step 1 Dose Level 2 Step 1 DL2: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3 Step 1 DL3: Copanlisib 60 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3A Step 1 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 2 Dose Level 1 Step 2 DL1: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID + Durvalumab 1500 mg IV on day 1 starting at C2D1 ; 28-day cycle"	Step 3 DDR Arm Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 3 PIK3CA/PTEN Arm Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle
Overall Study Adverse Event	1	1	1	0	0	0	0
Overall Study Death	0	1	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	2	1	0	0	2
Overall Study Progression	8	1	7	5	4	2	3

Baseline Characteristics

Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Step 1 Dose Level 1 n=9 Participants Step 1 DL1: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 200 mg PO BID; 28-day cycle	Step 1 Dose Level 2 n=3 Participants Step 1 DL2: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3 n=10 Participants Step 1 DL3: Copanlisib 60 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3A n=6 Participants Step 1 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 2 Dose Level 1 n=4 Participants Step 2 DL1: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID + Durvalumab 1500 mg IV on day 1 starting at C2D1 ; 28-day cycle"	Step 3 DDR Arm n=2 Participants Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 3 PIK3CA/PTEN Arm n=5 Participants Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	27 Participants n=24 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	12 Participants n=24 Participants
Age, Continuous	63 years n=5 Participants	67 years n=7 Participants	59 years n=5 Participants	63.5 years n=4 Participants	51 years n=21 Participants	44.5 years n=8 Participants	64 years n=8 Participants	60 years n=24 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	27 Participants n=24 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants	12 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	35 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 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	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants	34 Participants n=24 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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Region of Enrollment United States	9 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants	6 participants n=4 Participants	4 participants n=21 Participants	2 participants n=8 Participants	5 participants n=8 Participants	39 participants n=24 Participants

PRIMARY outcome

Timeframe: The DLT monitoring time frame was Cycle 1 through Cycle 2 Day 1 for the doublet combination (SIL1, SIL2, SIL3, and SIL3A) , and Cycle 1 through Cycle 3 Day 1 for the triplet combination (S2L1)

Population: To be evaluable for DLT, patients must receive at least 75% of Olaparib doses and have no missed Copanlisib doses. In Step 1 dose level 3, Step 1 dose level 3A, Step 2 dose level 1, and Step 3 PIK3CA/PTEN arm, 8 patients were not evaluable for DLT because they did not receive sufficient drug in Cycle 1.

Outcome measures

Outcome measures
Measure	Step 1 Dose Level 1 n=9 Participants Step 1 DL1: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 200 mg PO BID; 28-day cycle	Step 1 Dose Level 2 n=3 Participants Step 1 DL2: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3 n=10 Participants Step 1 DL3: Copanlisib 60 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3A n=6 Participants Step 1 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 2 Dose Level 1 n=4 Participants Step 2 DL1: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID + Durvalumab 1500 mg IV on day 1 starting at C2D1 ; 28-day cycle"	Step 3 DDR Arm n=2 Participants Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 3 PIK3CA/PTEN Arm n=5 Participants Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle
Number of Patients With Dose Limiting Toxicities (DLT) as a Measure of Safety Profile to Determine Recommended Phase 2 Dose (RP2D) DLT	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Dose Limiting Toxicities (DLT) as a Measure of Safety Profile to Determine Recommended Phase 2 Dose (RP2D) No DLT	8 Participants	3 Participants	4 Participants	5 Participants	3 Participants	2 Participants	3 Participants
Number of Patients With Dose Limiting Toxicities (DLT) as a Measure of Safety Profile to Determine Recommended Phase 2 Dose (RP2D) Not evaluable for DLT	0 Participants	0 Participants	4 Participants	1 Participants	1 Participants	0 Participants	2 Participants

Adverse Events

Step 1 Dose Level 1

Serious events: 5 serious events

Other events: 9 other events

Deaths: 9 deaths

Step 1 Dose Level 2

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Step 1 Dose Level 3

Serious events: 5 serious events

Other events: 10 other events

Deaths: 8 deaths

Step 1 Dose Level 3A

Serious events: 5 serious events

Other events: 6 other events

Deaths: 2 deaths

Step 2 Dose Level 1

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Step 3 DDR Arm

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Step 3 PIK3CA/PTEN Arm

Serious events: 5 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Step 1 Dose Level 1 n=9 participants at risk Step 1 DL1: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 200 mg PO BID; 28-day cycle	Step 1 Dose Level 2 n=3 participants at risk Step 1 DL2: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3 n=10 participants at risk Step 1 DL3: Copanlisib 60 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3A n=6 participants at risk Step 1 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 2 Dose Level 1 n=4 participants at risk Step 2 DL1: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID + Durvalumab 1500 mg IV on day 1 starting at C2D1 ; 28-day cycle"	Step 3 DDR Arm n=2 participants at risk Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 3 PIK3CA/PTEN Arm n=5 participants at risk Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle
Gastrointestinal disorders Abdominal pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations ALT increased	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations AST increased	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Chills	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Dehydration	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Disease progression	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Nervous system disorders Dizziness	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Dysphagia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Esophageal obstruction	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Fall	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Fatigue	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Fever	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Vascular disorders Hypertension	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hypoatremia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Lung infection	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Mucositis oral	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Multi-organ failure	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Nausea	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Neutrophil count decreased	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Pain	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders Rash maculo-papular	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Sepsis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Skin infection	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Vascular disorders Thromboembolic event	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Upper respiratory infection	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Urinary tract infection	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 2/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations White blood cell decreased	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.

Other adverse events

Other adverse events
Measure	Step 1 Dose Level 1 n=9 participants at risk Step 1 DL1: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 200 mg PO BID; 28-day cycle	Step 1 Dose Level 2 n=3 participants at risk Step 1 DL2: Copanlisib 45 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3 n=10 participants at risk Step 1 DL3: Copanlisib 60 mg IV (days 1, 8, 15) + Olaparib 300 mg PO BID; 28-day cycle	Step 1 Dose Level 3A n=6 participants at risk Step 1 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 2 Dose Level 1 n=4 participants at risk Step 2 DL1: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID + Durvalumab 1500 mg IV on day 1 starting at C2D1 ; 28-day cycle"	Step 3 DDR Arm n=2 participants at risk Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle	Step 3 PIK3CA/PTEN Arm n=5 participants at risk Step 3 DL3A: Copanlisib 60 mg IV (days 1 and15) + Olaparib 300 mg PO BID; 28-day cycle
Blood and lymphatic system disorders Anemia	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	100.0% 3/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	30.0% 3/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 2/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	60.0% 3/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Abdominal Distension	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Abdominal Pain	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 2/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Renal and urinary disorders Acute kidney injury	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Alkaline phosphatase increased	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Allergic reaction	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations ALT increased	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	30.0% 3/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Anorexia	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 4/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	75.0% 3/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Anxiety	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Ascites	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations AST increased	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	30.0% 3/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Cardiac disorders Atrial fibrillation	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 3/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Bacteremia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Bloating	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Blood bukurubin increased	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	30.0% 3/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Blood and lymphatic system disorders Neutrophil count decreased	33.3% 3/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 5/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Blood and lymphatic system disorders Blood/lymph - Other - Mild Leukocytosis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Blurred vision	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Cardiac troponin I increased	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Chills	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Colitis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Confusion	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Constipation	33.3% 3/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 4/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	75.0% 3/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Corneal ulcer	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 2/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	75.0% 3/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Creatinine increased	33.3% 3/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	30.0% 3/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Dehydration	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 3/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Diarrhea	44.4% 4/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 5/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	83.3% 5/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	100.0% 2/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Nervous system disorders Dizziness	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 2/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Dry Eye	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Dry Mouth	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Nervous system disorders Dysesthesia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Nervous system disorders Dysgeusia	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Dysphagia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	83.3% 5/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Renal and urinary disorders Dysuria	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Ear and labyrinth - other - Phonophobia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Ear pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Edema limbs	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Elevated LDH	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 2/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Esophageal stenosis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Eye disorders - Other, specify - ocular erythema	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Eye disorders - Other, specify - stye	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Eye disorders - Other, specify - Subjunctival Hemorrhage	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Eye disorders - Other, specify - Swollen	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Eye pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Eyelid function disorder	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Facial pain	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Fall	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Fatigue	33.3% 3/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 4/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	100.0% 2/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	80.0% 4/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Fever	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 4/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Flatulence	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Flu like symptoms	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Fracture	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Gait disturbance	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Gastroesophageal reflux disease	44.4% 4/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Gastrointestinal fistula	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Generalized edema	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders GI disorders - Other, specify - Ileus	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders GI disorders - Other, specify - Stomach Bug	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders GI disorders - Other, specify - Swollen Tongue	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Nervous system disorders Headache	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Hemmorrhoids	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Vascular disorders Hot flashes	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hyperglycemia	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 4/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 3/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	60.0% 3/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Vascular disorders Hypertension	33.3% 3/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	83.3% 5/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hypokalemia	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	75.0% 3/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hypoatremia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	60.0% 3/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	60.0% 3/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Vascular disorders Hypotension	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Hypothyroidism	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Ilean ulcer	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Infections & infestations - Other - Kidney Infection	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Infections & infestations - Other - Picc Line Infection	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Infections & infestations - Other - Sars-Cov-2 Virus	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Infections & infestations - Other - Sepsis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Infections & infestations - Other - Tumor Necrosis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Insomnia	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Lipase increased	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Lung infection	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Lymphocyte count decreased	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Malaise	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Metabolism and nutrition disorders Metabolism and nutrition - Other - Iron Deficiency	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Mucositis oral	44.4% 4/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 4/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 2/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Musculoskeletal and connective tissue disorders Muscle cramp	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Nausea	44.4% 4/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 5/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	83.3% 5/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	100.0% 4/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 2/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Night blindness	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Pain	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 3/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Weight Loss	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 3/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders pain of skin	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Cardiac disorders Palpitations	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Nervous system disorders Paresthesia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Pelvic pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Nervous system disorders Phantom pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Vascular disorders Phlebitis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Photophobia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Platelet count decreased	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 2/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders portal vein thrombosis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Postnasal drip	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders Pruitis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders Rash maculo-papular	66.7% 6/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 4/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 3/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 2/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	60.0% 3/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Rectal fistula	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Rectal pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Renal and urinary disorders Renal & urinary disorders - Other - Incomplete Voiding	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Reproductive and breast - Other - Uterine Fibroid	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Resp, thoracic & mediast - Other - Dry Mucous Membrane To Nose And Mouth	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations Serum amylase increased	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Cardiac disorders Sinus bradycardia	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Sinus pain	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Cardiac disorders Sinus tachycardia	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 4/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 2/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Sinusitis	22.2% 2/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders Skin & subcutaneous tissue -Other - Buttock Skin Irritation	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders Skin & subcutaneous tissue -Other - Hand Blisters	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders Skin & subcutaneous tissue -Other - Skin Changes, Pathches	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Skin and subcutaneous tissue disorders Skin & subcutaneous tissue -Other - Tick Bite	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Skin infection	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Skin ulceration	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders sore throat	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Stomach pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Vascular disorders Superficial thrombophlebitis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Blepharoplasty	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Bronchoscopy	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Gastrointestinal Endoscopy	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Insertion Of 4 Fr Double (Lumen Left Brachial Picc)	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical&medical-Other-Insertion Of Tunneled Centrally Inserted Central Venous Catheter w/SQ port	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Ir Transjugular Liver Biopsy	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Lumbar Puncture	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Nephrostomy Exchange	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Nephrostomy Tube Placement	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Nephrostomy Unilateral Placement (Hepatic Arterial Embolization)	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Paracentesis	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Picc Insertion	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Port-A-Cath Placement	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Punch Biopsy Of Left Hand	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Stent	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Suture Removal Of Left Hand	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Surgical and medical - Other - Tooth Extraction	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Nervous system disorders Syncope	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Vascular disorders Thromboembolic event	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	40.0% 2/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Infections and infestations Upper respiratory infection	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Renal and urinary disorders Urinary frequency	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Renal and urinary disorders Urinary urgency	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	20.0% 1/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Vaginal discharge	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Vaginal pain	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Gastrointestinal disorders Vomiting	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 4/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	50.0% 1/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Respiratory, thoracic and mediastinal disorders Wheezing	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
Investigations White blood cell decreasing	11.1% 1/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	66.7% 2/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	16.7% 1/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	25.0% 1/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.
General disorders Watering eyes	0.00% 0/9 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	33.3% 1/3 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	10.0% 1/10 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/6 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/4 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/2 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.	0.00% 0/5 • Approximately four years and eight months, from the time the first patient signed the informed consent, throughout the treatment period, and up to 90 days after the administration of the last dose of study drug. Incidence and causality of all adverse events (AE) of all grades and attribution for all patients treated on-study, and were graded based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5. All advserse events were captured from the time of signing consent through 90 days after the administration of the last dose of study drug. Only the highest graded AE per patient was evaluated per AE event term listed below.

Additional Information

Dr. Timothy Yap

The University of Texas MD Anderson Cancer Center

Phone: (713) 839-5458

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60