Trial Outcomes & Findings for Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer (NCT NCT03523572)

Last Updated: 2025-01-27

Results Overview

A Dose-Limiting Toxicity (DLT) is defined as any Treatment Emergent Adverse Event not attributable to disease or disease-related processes that occurs during the DLT evaluation period (2 complete cycles during Part 1) and is Grade 3 or above according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Each cycle is 21 days. Low dose was set at 3.2 mg/kg and high dose was set at 5.4 mg/kg.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

86 participants

Primary outcome timeframe

Cycles 1 and 2 (each cycle is 21 days)

Results posted on

2025-01-27

Participant Flow

A total of 86 participants were enrolled and treated at 21 study sites in US and Europe. Final study results are reported for all outcome measures.

The Dose Escalation was intended to identify the maximum tolerated dose (MTD) of T-DXd in combination with a fixed dose of nivolumab.

Participant milestones

Participant milestones
Measure	Dose Escalation (3.2 mg/kg) Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 1 (5.4 mg/kg): HER2 Positive BC Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined positive HER2 expression (IHC 3+ or IHC 2+/ISH+) \[as defined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines\] and have received prior ado-trastuzumab emtansine (T-DM1) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Dose Escalation STARTED	4	3	0	0	0	0
Dose Escalation COMPLETED	0	1	0	0	0	0
Dose Escalation NOT COMPLETED	4	2	0	0	0	0
Dose Expansion STARTED	0	0	29	16	30	4
Dose Expansion COMPLETED	0	0	6	1	4	0
Dose Expansion NOT COMPLETED	0	0	23	15	26	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation (3.2 mg/kg) Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 1 (5.4 mg/kg): HER2 Positive BC Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined positive HER2 expression (IHC 3+ or IHC 2+/ISH+) \[as defined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines\] and have received prior ado-trastuzumab emtansine (T-DM1) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Dose Escalation Progressive disease	1	0	0	0	0	0
Dose Escalation Clinical Progression	0	1	0	0	0	0
Dose Escalation Adverse Event	2	0	0	0	0	0
Dose Escalation Physician Decision	1	1	0	0	0	0
Dose Expansion Progressive Disease	0	0	9	11	15	2
Dose Expansion Clinical Progression	0	0	2	2	2	0
Dose Expansion Adverse Event	0	0	10	1	5	2
Dose Expansion Withdrawal by Subject	0	0	1	1	0	0
Dose Expansion Physician Decision	0	0	1	0	1	0
Dose Expansion Miscellaneous	0	0	0	0	3	0

Baseline Characteristics

Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation (3.2 mg/kg) n=4 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=3 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Expansion Cohort 1 (5.4 mg/kg): HER2 Positive BC n=29 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined positive HER2 expression (IHC 3+ or IHC 2+/ISH+) \[as defined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines\] and have received prior ado-trastuzumab emtansine (T-DM1) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC n=16 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC n=30 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=4 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Total n=86 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
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	24 Participants n=5 Participants	16 Participants n=4 Participants	8 Participants n=21 Participants	2 Participants n=8 Participants	53 Participants n=8 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	22 Participants n=21 Participants	2 Participants n=8 Participants	33 Participants n=8 Participants
Age, Continuous	60.73 years STANDARD_DEVIATION 10.978 • n=5 Participants	63.99 years STANDARD_DEVIATION 16.995 • n=7 Participants	56.37 years STANDARD_DEVIATION 9.799 • n=5 Participants	48.11 years STANDARD_DEVIATION 8.781 • n=4 Participants	69.29 years STANDARD_DEVIATION 10.352 • n=21 Participants	59.71 years STANDARD_DEVIATION 13.308 • n=8 Participants	59.48 years STANDARD_DEVIATION 12.672 • n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	29 Participants n=5 Participants	16 Participants n=4 Participants	27 Participants n=21 Participants	3 Participants n=8 Participants	82 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 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
Race (NIH/OMB) Asian	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	2 Participants n=8 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	23 Participants n=5 Participants	14 Participants n=4 Participants	28 Participants n=21 Participants	4 Participants n=8 Participants	75 Participants n=8 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	2 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 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	1 Participants n=8 Participants
Region of Enrollment Belgium	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants	2 participants n=8 Participants	7 participants n=8 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	17 participants n=5 Participants	7 participants n=4 Participants	7 participants n=21 Participants	0 participants n=8 Participants	38 participants n=8 Participants
Region of Enrollment Italy	0 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	7 participants n=21 Participants	1 participants n=8 Participants	12 participants n=8 Participants
Region of Enrollment United Kingdom	0 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants	0 participants n=8 Participants	5 participants n=8 Participants
Region of Enrollment France	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants	0 participants n=8 Participants	2 participants n=8 Participants
Region of Enrollment Germany	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	4 participants n=21 Participants	1 participants n=8 Participants	5 participants n=8 Participants
Region of Enrollment Spain	0 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants	7 participants n=4 Participants	6 participants n=21 Participants	0 participants n=8 Participants	17 participants n=8 Participants

PRIMARY outcome

Timeframe: Cycles 1 and 2 (each cycle is 21 days)

Population: DLT was assessed in the DLT evaluable set.

Outcome measures

Outcome measures
Measure	Dose Escalation (3.2 mg/kg) n=4 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=3 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). .	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Number of Participants With Dose-Limiting Toxicities at 3.2 mg/kg and 5.4 mg/kg Dose Level in Participants With HER2-expressing Advanced Breast Cancer in Dose Escalation	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Every 6 weeks in the first year after Day 1 of Cycle 1 and thereafter every 12 weeks until disease progression or initiation of additional anticancer therapy and survival, up to 2 years 11.5 months (each cycle is 21 days)

Population: Objective response rate was assessed in the Full Analysis Set. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported. As prespecified in the protocol, participants enrolled in Part 1 were pooled according to their trastuzumab deruxtecan dose and HER2 expressing levels (HER2 positive or HER2 low) for efficacy analyses. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Outcome measures

Outcome measures
Measure	Dose Escalation (3.2 mg/kg) n=4 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=32 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC n=16 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC n=30 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=4 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). .	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer	25.0 Percentage of Participants The curve that represents the upper CI for the response rate lies above 0.75, therefore the upper CI for first quartile could not be estimated. Similarly, the curve that represents the lower CI for the response rate lies above 0.75 and the lower CI for the quartile could not be estimated.	65.6 Percentage of Participants Interval 46.8 to 81.4	50.0 Percentage of Participants Interval 24.7 to 75.3	36.7 Percentage of Participants Interval 19.9 to 56.1	50.0 Percentage of Participants The curve that represents the upper CI for the response rate lies above 0.75, therefore the upper CI for first quartile could not be estimated. Similarly, the curve that represents the lower CI for the response rate lies above 0.75 and the lower CI for the quartile could not be estimated.	—

SECONDARY outcome

Population: Duration of Response (DoR) was assessed in the Full Analysis Set of participants with available data with confirmed CR/PR. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. DoR in participants with confirmed CR/PR based on independent central review and investigator assessment is reported. As prespecified in the protocol, participants enrolled in Part 1 were pooled according to their trastuzumab deruxtecan dose and HER2 expressing levels (HER2 positive or HER2 low) for efficacy analyses. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Outcome measures

Outcome measures
Measure	Dose Escalation (3.2 mg/kg) Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=44 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC n=15 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC n=23 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=3 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). .	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Duration of Response (DoR) in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer Independent Central Review	—	NA months Interval 7.9 to Median was not reached at the end of follow up and the upper 95% CI was not estimable	5.5 months Interval 2.8 to 8.0	13.1 months Interval 4.1 to Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it could not be calculated.	NA months Median was not reached at the end of follow up and 95% CIs could not be calculated	—
Duration of Response (DoR) in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer Investigator Assessment	—	20.2 months Interval 10.4 to Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it could not be calculated.	5.8 months Interval 5.2 to 10.4	8.7 months Interval 2.8 to Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it could not be calculated.	NA months Median was not reached at the end of follow up and 95% CIs could not be calculated	—

SECONDARY outcome

Population: Disease control rate was assessed in the Full Analysis Set. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Disease Control Rate (DCR) was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) during study treatment. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and SD as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Confirmation of CR/PR was required. DCR based on independent central review and investigator assessment is reported. As prespecified in the protocol, participants enrolled in Part 1 were pooled according to their trastuzumab deruxtecan dose and HER2 expressing levels (HER2 positive or HER2 low) for efficacy analyses. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Outcome measures

Outcome measures
Measure	Dose Escalation (3.2 mg/kg) n=4 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=32 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC n=16 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC n=30 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=4 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). .	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Percentage of Participants With Disease Control Rate (DCR) in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer Independent Central Review	50 Percentage of Participants There were not enough events to estimate a standard error for the DCR and the 95% CI could not be calculated	93.8 Percentage of Participants Interval 79.2 to 99.2	75.0 Percentage of Participants Interval 47.6 to 92.7	76.7 Percentage of Participants Interval 57.7 to 90.1	75.0 Percentage of Participants There were not enough events to estimate a standard error for the DCR and the 95% CI could not be calculated	—
Percentage of Participants With Disease Control Rate (DCR) in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer Investigator Assessment	50 Percentage of Participants There were not enough events to estimate a standard error for the DCR and the 95% CI could not be calculated	93.8 Percentage of Participants Interval 79.2 to 99.2	87.5 Percentage of Participants Interval 61.7 to 98.4	73.3 Percentage of Participants Interval 54.1 to 87.7	50 Percentage of Participants There were not enough events to estimate a standard error for the DCR and the 95% CI could not be calculated	—

SECONDARY outcome

Population: Progression-free survival (PFS) was assessed in the Full Analysis Set. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. PFS based on independent central review and investigator assessment is reported. As prespecified in the protocol, participants enrolled in Part 1 were pooled according to their trastuzumab deruxtecan dose and HER2 expressing levels (HER2 positive or HER2 low) for efficacy analyses. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Outcome measures

Outcome measures
Measure	Dose Escalation (3.2 mg/kg) Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=32 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC n=16 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC n=30 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=4 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). .	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Progression-Free Survival (PFS) in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer Independent Central Review	—	11.6 months Interval 6.9 to Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it could not be calculated.	7.0 months Interval 2.3 to 10.8	6.9 months Interval 2.7 to 14.4	NA months Median was not reached at the end of follow up and 95% CIs could not be calculated.	—
Progression-Free Survival (PFS) in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer Investigator Assessment	—	18.0 months Interval 11.0 to Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it could not be calculated.	7.8 months Interval 2.4 to 9.8	5.5 months Interval 2.7 to 8.5	NA months Median was not reached at the end of follow up and 95% CIs could not be calculated.	—

SECONDARY outcome

Population: Time to response was assessed in the Full Analysis Set. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Time to response (TTR) is defined as the time from the date of first dose of study treatment to the date of the first documented objective response (CR or PR). CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmation of CR/PR was required. TTR based on independent central review and investigator assessment is reported. As prespecified in the protocol, participants enrolled in Part 1 were pooled according to their trastuzumab deruxtecan dose and HER2 expressing levels (HER2 positive or HER2 low) for efficacy analyses. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Outcome measures

Outcome measures
Measure	Dose Escalation (3.2 mg/kg) n=1 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=32 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC n=16 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC n=30 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=4 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). .	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Time to Response (TTR) Based on Independent Central Review in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer	1.41 months Interval 1.41 to 1.41	1.61 months Interval 1.2 to 5.5	3.73 months Interval 2.6 to 9.8	1.87 months Interval 1.2 to 6.9	3.25 months Interval 1.2 to 5.3	—

SECONDARY outcome

Timeframe: Date of first dose of study drug to the date of death due to any cause, up to 5 years

Population: Overall survival (OS) was assessed in the Full Analysis Set. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause. As prespecified in the protocol, participants enrolled in Part 1 were pooled according to their trastuzumab deruxtecan dose and HER2 expressing levels (HER2 positive or HER2 low) for efficacy analyses. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Outcome measures

Outcome measures
Measure	Dose Escalation (3.2 mg/kg) n=4 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=32 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC n=16 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC n=30 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=4 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). .	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Overall Survival (OS) in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer	NA months Median was not reached at the end of follow up and 95% CIs could not be calculated	NA months Interval 20.8 to Median was not reached at the end of follow up and the upper 95% CI was not estimable	19.5 months Interval 2.7 to Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it could not be calculated.	11.0 months Interval 7.2 to Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it could not be calculated.	NA months Median was not reached at the end of follow up and 95% CIs could not be calculated	—

SECONDARY outcome

The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment (IA) based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on IA is reported. As prespecified in the protocol, participants enrolled in Part 1 were pooled according to their trastuzumab deruxtecan dose and HER2 expressing levels (HER2 positive or HER2 low) for efficacy analyses. Participants who were dosed at 5.4 mg/kg of trastuzumab deruxtecan and have HER2-positive expression Breast Cancer (IHC score 3+ or IHC score 2+/ISH+) in Part 1 were pooled with the same participants from Part 2 (in this case, participants enrolled in Cohort 1).

Outcome measures

Outcome measures
Measure	Dose Escalation (3.2 mg/kg) n=4 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=32 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC n=16 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC n=30 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=4 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). .	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment in Participants With HER2-expressing Advanced Breast Cancer or Urothelial Cancer	25 Percentage of Participants There were not enough events to estimate a standard error for the ORR and the 95% CI could not be calculated	71.9 Percentage of Participants Interval 53.3 to 86.3	43.8 Percentage of Participants Interval 19.8 to 70.1	40.0 Percentage of Participants Interval 22.7 to 59.4	25.0 Percentage of Participants There were not enough events to estimate a standard error for the ORR and the 95% CI could not be calculated	—

SECONDARY outcome

Timeframe: Date of signing the informed consent form up to 100 days after last dose of study drug or start of a new anticancer drug (whichever occurs first), up to 5 years

Population: TEAEs were assessed in the Safety Analysis Set.

A treatment-emergent adverse event (TEAE) was defined as an AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiating the study drug until 47 days after last dose of study drug.

Outcome measures

Outcome measures
Measure	Dose Escalation (3.2 mg/kg) n=4 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=3 Participants Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 2 (5.4 mg/kg): HER2 Low BC n=29 Participants Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3 (5.4 mg/kg): HER2 High Expressing (IHC 2+/3+) UC n=16 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=30 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). .	Dose Expansion Cohort 4 (5.4 mg/kg): HER2 Low Expressing (IHC 1+) UC n=4 Participants Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	4 Participants	3 Participants	29 Participants	16 Participants	30 Participants	4 Participants

Adverse Events

Dose Escalation (3.4 mg/kg)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Dose Escalation (5.4 mg/kg)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Dose Expansion Cohort 1: HER2 Positive BC

Serious events: 12 serious events

Other events: 29 other events

Deaths: 7 deaths

Dose Expansion Cohort 2: HER2 Low BC

Serious events: 4 serious events

Other events: 16 other events

Deaths: 8 deaths

Dose Expansion Cohort 3: HER2 High Expressing (IHC 2+/3+) UC

Serious events: 17 serious events

Other events: 30 other events

Deaths: 17 deaths

Dose Expansion Cohort 4: HER2 Low Expressing (IHC 1+) UC

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation (3.4 mg/kg) n=4 participants at risk Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=3 participants at risk Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 1: HER2 Positive BC n=29 participants at risk Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined positive HER2 expression (IHC 3+ or IHC 2+/ISH+) \[as defined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines\] and have received prior ado-trastuzumab emtansine (T-DM1) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 2: HER2 Low BC n=16 participants at risk Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3: HER2 High Expressing (IHC 2+/3+) UC n=30 participants at risk Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4: HER2 Low Expressing (IHC 1+) UC n=4 participants at risk Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Nervous system disorders Spinal Cord Compression	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Subileus	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Disease Progression	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Urinary tract infection	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.3% 4/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders General physical health deterioration	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Pneumonia	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Peritonitis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Pneumothorax	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Postprocedural haematoma	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Pyelonephritis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Hepatobiliary disorders Bile duct obstruction	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Pancreatitis	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Cardiac disorders Pericardial effusion	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Haemorrhage intracranial	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Blood and lymphatic system disorders Anaemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Ascites	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Bronchitis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Cachexia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Covid-19	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Epilepsy	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Gastric Haemorrhage	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Blood and lymphatic system disorders Haemolytic Anaemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Large Intestine Perforation	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Pelvic Abscess	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Procedural Pneumothorax	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Pyrexia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Seizure	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Troponin T Increased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Associated Fever	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Ureteric Obstruction	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Urosepsis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Urostomy Complication	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.

Other adverse events

Other adverse events
Measure	Dose Escalation (3.4 mg/kg) n=4 participants at risk Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 3.2 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Escalation (5.4 mg/kg) n=3 participants at risk Participants with HER2-expressing breast cancer who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W). Escalating/de-escalating doses of trastuzumab deruxtecan in combination with a flat dose of nivolumab was administered on Day 1 of each 21-day cycle.	Dose Expansion Cohort 1: HER2 Positive BC n=29 participants at risk Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined positive HER2 expression (IHC 3+ or IHC 2+/ISH+) \[as defined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines\] and have received prior ado-trastuzumab emtansine (T-DM1) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 2: HER2 Low BC n=16 participants at risk Participants with pathologically documented advanced/metastatic breast cancer (BC) that has centrally-determined low HER2 expression (IHC 1+ or IHC 2+/ISH-) who have exhausted treatments that can confer any clinically meaningful benefit (e.g. other therapies such as hormonal therapy for patients who are hormone receptor positive) who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 3: HER2 High Expressing (IHC 2+/3+) UC n=30 participants at risk Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 2+ or 3+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).	Dose Expansion Cohort 4: HER2 Low Expressing (IHC 1+) UC n=4 participants at risk Participants with pathologically documented advanced/metastatic urothelial carcinoma (UC) that has centrally-determined HER2 expression of IHC 1+, who received prior platinum-based therapy with documented progression who received starting intravenous dose of trastuzumab deruxtecan at 5.4 mg/kg and a fixed intravenous dose of 360mg of nivolumab every 3 weeks (Q3W).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Nausea	50.0% 2/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	55.2% 16/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	62.5% 10/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	73.3% 22/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	75.0% 3/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Fatigue	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	100.0% 3/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	48.3% 14/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	37.5% 6/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	53.3% 16/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	50.0% 2/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	31.0% 9/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	50.0% 8/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	46.7% 14/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	66.7% 2/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	37.9% 11/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	37.5% 6/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	43.3% 13/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Constipation	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	48.3% 14/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	43.8% 7/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	26.7% 8/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Decreased Appetite	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	37.9% 11/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	37.5% 6/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	40.0% 12/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	37.9% 11/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	50.0% 8/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	26.7% 8/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	50.0% 2/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	66.7% 2/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	44.8% 13/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	37.5% 6/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	20.7% 6/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	37.5% 6/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	20.0% 6/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Urinary Tract Infection	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	17.2% 5/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	36.7% 11/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Aspartate Aminotransferase Increased	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	24.1% 7/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 4/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.3% 4/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Oedema Peripheral	75.0% 3/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	66.7% 2/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	20.7% 6/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	16.7% 5/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	17.2% 5/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	18.8% 3/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.3% 4/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	17.2% 5/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 4/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Headache	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	18.8% 3/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	16.7% 5/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Endocrine disorders Hypothyroidism	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	16.7% 5/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Eye disorders Vision Blurred	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	27.6% 8/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.3% 4/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Asthenia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	20.0% 6/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	17.2% 5/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	18.8% 3/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.0% 3/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 4/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	20.0% 6/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.3% 4/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	50.0% 2/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Pyrexia	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	17.2% 5/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	16.7% 5/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Alanine Aminotransferase Increased	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	18.8% 3/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	16.7% 5/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hypokalaemia	50.0% 2/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	20.7% 6/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.0% 3/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	17.2% 5/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Abdominal Pain	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.3% 4/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Blood Alkaline Phosphatase Increased	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.0% 3/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Dysgeusia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	20.0% 6/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	50.0% 2/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Neutrophil Count Decreased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	50.0% 2/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Stomatitis	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	18.8% 3/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Amylase Increased	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.3% 4/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Blood Creatinine Increased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	20.0% 6/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	18.8% 3/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Haematuria	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.3% 4/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.0% 3/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	50.0% 2/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Dizziness	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.0% 3/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Eye disorders Dry Eye	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders General Physical Health Deterioration	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.0% 3/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Lipase Increased	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.3% 4/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Lymphocyte Count Decreased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Weight Decreased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations White Blood Cell Count Decreased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Blood Bilirubin Increased	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Disease Progression	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Dry Mouth	75.0% 3/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Dysuria	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Psychiatric disorders Insomnia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	13.8% 4/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.0% 3/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Malaise	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Mucosal Inflammation	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Pneumonia	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Chills	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Eye disorders Conjunctivitis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Gamma-Glutamyltransferase Increased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Eye disorders Keratitis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 4/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Neuropathy Peripheral	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Platelet Count Decreased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.3% 3/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Abdominal Distension	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	10.0% 3/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Reproductive system and breast disorders Breast Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Psychiatric disorders Depression	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Flatulence	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Vascular disorders Hypotension	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Influenza Like Illness	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Iron Deficiency	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Nail Disorder	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Oral Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Rectal Haemorrhage	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Aphthous Ulcer	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Ascites	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Blood Lactate Dehydrogenase Increased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Blood Thyroid Stimulating Hormone Increased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Covid-19	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Reproductive system and breast disorders Dyspareunia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Gait Disturbance	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	12.5% 2/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Psychiatric disorders Irritability	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Lethargy	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Odynophagia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Ear and labyrinth disorders Otitis Media	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Pain of Skin	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Pyelonephritis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Renal and urinary disorders Renal Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Sinusitis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Cardiac disorders Tachycardia	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Toothache	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.7% 2/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Tremor	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.9% 2/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Endocrine disorders Addison's Disease	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Endocrine disorders Adrenal Insufficiency	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Amnesia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Anal Haemorrhage	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Bilirubin Conjugated Increased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Blood Bilirubin Unconjugated Increased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Chest Discomfort	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Colitis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Ear and labyrinth disorders Ear Pain	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Eye disorders Eyelid Skin Dryness	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Folate Deficiency	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Gastroenteritis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Haemoglobin Decreased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Hernia Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Vascular disorders Hot Flush	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hyperamylasaemia	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.4% 1/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Metabolism and nutrition disorders Hypophosphataemia	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Progression	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Memory Impairment	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	3.3% 1/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Nail Infection	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Peritonitis	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Rash Macular	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Eye disorders Retinal Tear	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Nervous system disorders Sciatica	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Skin Disorder	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Skin Infection	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Musculoskeletal and connective tissue disorders Spinal Pain	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Investigations Transaminases Increased	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Viral Infection	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	6.2% 1/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	33.3% 1/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Hepatobiliary disorders Bile Duct Obstruction	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Infections and infestations Lower Respiratory Tract Infection	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Psychiatric disorders Mood Altered	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
General disorders Oedema	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Gastrointestinal disorders Pancreatitis	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Cardiac disorders Pericardial Effusion	25.0% 1/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/29 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/30 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.	0.00% 0/4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 100 days after last dose of the study drug, up 5 years. A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place