Trial Outcomes & Findings for Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb (NCT NCT04614246)

Last Updated: 2023-08-01

Results Overview

The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 \[+3\]). The time frame of 28 days captures a menstrual cycle on average.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

215 participants

Primary outcome timeframe

change from baseline to week 12

Results posted on

2023-08-01

Participant Flow

This multinational study was conducted between 29 JAN 2021 First Patient First Visit (FPFV) and 03 MAY 2022 Last Patient Last Visit (LPLV) in 20 countries/regions: Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Estonia, Finland , Germany, Greece, Hungary, Italy, Japan, Lithuania, Latvia, Norway, Poland, Slovakia, Spain, United States

A total of 215 participants were randomized to 5 treatment arms (44 to eliapixant, 44 to eliapixant, 43 to eliapixant, 43 to placebo, and 41 to Elagolix).

Participant milestones

Participant milestones
Measure	Eliapixant (BAY1817080) 25 mg 25mg eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 75 mg 75mg eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 150 mg 150mg eliapixant twice daily for 12 weeks	Placebo Placebo for eliapixant twice daily for 12 weeks	Elagolix 150mg 150mg Elagolix once daily for 12 weeks
Overall Study STARTED	44	44	43	43	41
Overall Study Valid for Safety Analysis Set (SAF)	39	38	38	37	38
Overall Study COMPLETED	28	22	22	24	24
Overall Study NOT COMPLETED	16	22	21	19	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Eliapixant (BAY1817080) 25 mg 25mg eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 75 mg 75mg eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 150 mg 150mg eliapixant twice daily for 12 weeks	Placebo Placebo for eliapixant twice daily for 12 weeks	Elagolix 150mg 150mg Elagolix once daily for 12 weeks
Overall Study Adverse Event	0	1	1	2	1
Overall Study Lost to Follow-up	0	1	0	1	3
Overall Study Other reason	0	1	2	0	0
Overall Study Withdrawal by Subject	4	2	4	3	4
Overall Study Physician Decision	0	2	1	0	0
Overall Study Study terminated by sponsor	10	15	12	13	9
Overall Study Pregnancy	2	0	1	0	0

Baseline Characteristics

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eliapixant (BAY1817080) 25 mg n=44 Participants 25mg eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 75 mg n=44 Participants 75mg eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 150 mg n=43 Participants 150mg eliapixant twice daily for 12 weeks	Placebo n=43 Participants Placebo for eliapixant twice daily for 12 weeks	Elagolix 150mg n=41 Participants 150mg Elagolix once daily for 12 weeks	Total n=215 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=10 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	44 Participants n=7 Participants	43 Participants n=5 Participants	43 Participants n=4 Participants	41 Participants n=21 Participants	215 Participants n=10 Participants
Age, Categorical >=65 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=10 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	44 Participants n=7 Participants	43 Participants n=5 Participants	43 Participants n=4 Participants	41 Participants n=21 Participants	215 Participants n=10 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	0 Participants n=21 Participants	0 Participants n=10 Participants
Race/Ethnicity, Customized White	31 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	29 Participants n=4 Participants	39 Participants n=21 Participants	160 Participants n=10 Participants
Race/Ethnicity, Customized Black or african american	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=10 Participants
Race/Ethnicity, Customized Asian	13 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	0 Participants n=21 Participants	48 Participants n=10 Participants
Race/Ethnicity, Customized Not reported	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	2 Participants n=10 Participants

PRIMARY outcome

Timeframe: change from baseline to week 12

Population: The Elagolix arm was not included in the primary per protocol set (pPPS) simply because it's not part of the primary objective which was "to assess the dose-response relationship and demonstrate efficacy of BAY 1817080 compared to placebo in women with symptomatic endometriosis".

Outcome measures

Outcome measures
Measure	Eliapixant (BAY1817080) 25 mg n=31 Participants Eliapixant 25 mg BID	Eliapixant (BAY1817080) 75 mg n=31 Participants Eliapixant 75 mg BID	Eliapixant (BAY1817080) 150 mg n=31 Participants 50 mg Eliapixant BID	Placebo n=30 Participants Placebo for Eliapixant BID	Elagolix 150 mg Elagolix 150 mg OD
Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) Baseline	6.40 units on a scale Standard Deviation 1.66	6.13 units on a scale Standard Deviation 1.77	6.95 units on a scale Standard Deviation 1.38	6.14 units on a scale Standard Deviation 1.96	—
Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) Week 12	4.57 units on a scale Standard Deviation 2.10	4.15 units on a scale Standard Deviation 2.49	5.15 units on a scale Standard Deviation 2.42	4.29 units on a scale Standard Deviation 1.71	—
Absolute Change in Mean Worst Endometriosis Associated Pelvic Pain (EAPP), Primary Per Protocol Set (pPPS) Week 12: Change from Baseline	-1.56 units on a scale Standard Deviation 1.35	-2.12 units on a scale Standard Deviation 2.66	-1.88 units on a scale Standard Deviation 2.03	-1.89 units on a scale Standard Deviation 1.91	—

SECONDARY outcome

Timeframe: change from baseline to week 12

Population: Per protocol set (PPS): includes 183 participants, which is 85.1% of the FAS population.

Outcome measures

Outcome measures
Measure	Eliapixant (BAY1817080) 25 mg n=37 Participants Eliapixant 25 mg BID	Eliapixant (BAY1817080) 75 mg n=37 Participants Eliapixant 75 mg BID	Eliapixant (BAY1817080) 150 mg n=36 Participants 50 mg Eliapixant BID	Placebo n=36 Participants Placebo for Eliapixant BID	Elagolix 150 mg n=37 Participants Elagolix 150 mg OD
Least Squares Mean (SE) Changes in Worst EAPP From Baseline to Week 12, Per Protocol Set	-1.60 units on a scale Standard Error 0.40	-2.07 units on a scale Standard Error 0.42	-1.97 units on a scale Standard Error 0.42	-1.89 units on a scale Standard Error 0.40	-2.69 units on a scale Standard Error 0.41

SECONDARY outcome

Timeframe: up to 14 days after the last study medication intake

Population: Safety analysis set (SAF) includes 190 participants (88.4%) since 25 participants (11.6%) did not receive any study intervention and was excluded from SAF.

A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.

Outcome measures

Outcome measures
Measure	Eliapixant (BAY1817080) 25 mg n=39 Participants Eliapixant 25 mg BID	Eliapixant (BAY1817080) 75 mg n=38 Participants Eliapixant 75 mg BID	Eliapixant (BAY1817080) 150 mg n=38 Participants 50 mg Eliapixant BID	Placebo n=37 Participants Placebo for Eliapixant BID	Elagolix 150 mg n=38 Participants Elagolix 150 mg OD
Number of Participants With Treatment-emergent Adverse Events (TEAE) Any serious TEAE	0 Participants	2 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Any drug related serious TEAE	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Any TEAE with outcome death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Any TEAE resulting in permanent discontinuation of studly drug	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Any TEAE	23 Participants	21 Participants	29 Participants	27 Participants	28 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Any drug related TEAE	4 Participants	6 Participants	10 Participants	10 Participants	13 Participants

Adverse Events

Eliapixant (BAY1817080) 25 mg

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Eliapixant (BAY1817080) 75 mg

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Eliapixant (BAY1817080) 150 mg

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

150 mg Elagolix

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Eliapixant (BAY1817080) 25 mg n=39 participants at risk 25 mg Eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 75 mg n=38 participants at risk 75 mg Eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 150 mg n=38 participants at risk 75 mg Eliapixant twice daily for 12 weeks	Placebo n=37 participants at risk Placebo for 12 weeks	150 mg Elagolix n=38 participants at risk 150 mg Elagolix once daily for 12 weeks
Gastrointestinal disorders Abdominal pain lower	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Carbuncle	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Liver function test increased	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Surgical and medical procedures Endometriosis ablation	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Vascular disorders Hypertensive crisis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.

Other adverse events

Other adverse events
Measure	Eliapixant (BAY1817080) 25 mg n=39 participants at risk 25 mg Eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 75 mg n=38 participants at risk 75 mg Eliapixant twice daily for 12 weeks	Eliapixant (BAY1817080) 150 mg n=38 participants at risk 75 mg Eliapixant twice daily for 12 weeks	Placebo n=37 participants at risk Placebo for 12 weeks	150 mg Elagolix n=38 participants at risk 150 mg Elagolix once daily for 12 weeks
Investigations Neutrophil count increased	2.6% 1/39 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Blood and lymphatic system disorders Anaemia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Blood and lymphatic system disorders Leukopenia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Blood and lymphatic system disorders Neutropenia	5.1% 2/39 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Blood and lymphatic system disorders Bone marrow oedema	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Ear and labyrinth disorders Ear pain	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Ear and labyrinth disorders Ear swelling	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Ear and labyrinth disorders Eustachian tube dysfunction	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Abdominal distension	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Abdominal pain	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Angular cheilitis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Constipation	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	7.9% 3/38 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Dental caries	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Diarrhoea	5.1% 2/39 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Dyspepsia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Food poisoning	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Gastritis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Nausea	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	13.2% 5/38 • Number of events 6 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Toothache	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Gastrointestinal disorders Vomiting	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	7.9% 3/38 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Asthenia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Chest pain	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Discomfort	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Fatigue	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Influenza like illness	2.6% 1/39 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Injection site pain	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Injection site reaction	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Malaise	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Oedema	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Pain	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Pyrexia	7.7% 3/39 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	8.1% 3/37 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Peripheral swelling	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.4% 2/37 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Vaccination site pain	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	10.5% 4/38 • Number of events 6 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	10.8% 4/37 • Number of events 7 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
General disorders Vaccination site swelling	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Immune system disorders Immunisation reaction	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Bacterial vaginosis	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Bronchitis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Carbuncle	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Cystitis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Ear infection	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Gastroenteritis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Genital herpes	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Hordeolum	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Influenza	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Laryngitis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Lice infestation	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Nasopharyngitis	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	10.5% 4/38 • Number of events 4 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.4% 2/37 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Pneumonia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Pulpitis dental	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Tonsillitis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Upper respiratory tract infection	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	7.9% 3/38 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.4% 2/37 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Urinary tract infection	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations Vaginal infection	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Infections and infestations COVID-19	7.7% 3/39 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Activated partial thromboplastin time abnormal	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Activated partial thromboplastin time prolonged	7.7% 3/39 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	10.8% 4/37 • Number of events 4 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	13.2% 5/38 • Number of events 6 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Alanine aminotransferase increased	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Amylase increased	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Aspartate aminotransferase increased	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Blood fibrinogen decreased	7.7% 3/39 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	7.9% 3/38 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Blood fibrinogen increased	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	7.9% 3/38 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Blood glucose abnormal	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Full blood count abnormal	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Gamma-glutamyltransferase increased	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Haemoglobin decreased	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Lipase increased	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Lymphocyte count decreased	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Prothrombin time abnormal	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Prothrombin time prolonged	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations White blood cell count increased	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Platelet count increased	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Coagulation test abnormal	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Coronavirus test positive	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations Liver function test increased	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Investigations SARS-CoV-2 test positive	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.4% 2/37 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Metabolism and nutrition disorders Dehydration	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Metabolism and nutrition disorders Gout	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Metabolism and nutrition disorders Metabolic syndrome	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Musculoskeletal and connective tissue disorders Myalgia	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.4% 2/37 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Anosmia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Dizziness	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Dysgeusia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Headache	17.9% 7/39 • Number of events 15 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	18.4% 7/38 • Number of events 11 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	15.8% 6/38 • Number of events 9 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	24.3% 9/37 • Number of events 17 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	21.1% 8/38 • Number of events 15 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Hypogeusia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	7.9% 3/38 • Number of events 3 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Migraine	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 4 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Paraesthesia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Somnolence	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Psychogenic seizure	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Nervous system disorders Taste disorder	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Psychiatric disorders Anxiety	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Psychiatric disorders Depressed mood	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Psychiatric disorders Irritability	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Psychiatric disorders Mood altered	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Psychiatric disorders Nightmare	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Psychiatric disorders Panic attack	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Psychiatric disorders Sleep disorder	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Renal and urinary disorders Bladder pain	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Cervix disorder	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Fibrocystic breast disease	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Intermenstrual bleeding	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Oligomenorrhoea	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Pelvic pain	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.3% 2/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Adnexa uteri cyst	2.6% 1/39 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Genital haemorrhage	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Skin and subcutaneous tissue disorders Rash	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.7% 1/37 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Vascular disorders Hypertension	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Vascular disorders Hypertensive crisis	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Vascular disorders Varicose vein	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/37 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	2.6% 1/38 • Number of events 1 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.
Vascular disorders Hot flush	0.00% 0/39 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	0.00% 0/38 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	5.4% 2/37 • Number of events 2 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.	18.4% 7/38 • Number of events 7 • From start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks. While for the all-cause mortality that occurred at any time during the study before the last contact, up to 285 days. A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake.

Additional Information

Therapeutic Area Head

Bayer AG

Phone: 1-888-8422937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60