Trial Outcomes & Findings for Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC (NCT NCT03674827)

NCT ID: NCT03674827

Last Updated: 2024-08-23

Results Overview

An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or considered to be an important medical event. AEs included both SAEs and non-serious AEs.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 36 participants
• Primary outcome timeframe: Baseline up to 6 months after End of Treatment (EOT; 22 months in maximum)
• Results posted on: 2024-08-23

Participant Flow

A total of 55 participants were screened and 36 of them were enrolled and treated in this study.

Participant milestones

Measure	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Treatment Phase STARTED	3	4	3	5	5	16
Treatment Phase COMPLETED	0	0	0	0	0	0
Treatment Phase NOT COMPLETED	3	4	3	5	5	16
Long-Term Follow-up Phase STARTED	3	4	3	5	5	16
Long-Term Follow-up Phase COMPLETED	0	0	0	0	0	0
Long-Term Follow-up Phase NOT COMPLETED	3	4	3	5	5	16

Reasons for withdrawal

Measure	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Treatment Phase Adverse Event	0	0	0	0	0	2
Treatment Phase Death	0	0	2	0	1	0
Treatment Phase Progressive Disease	3	4	0	4	4	9
Treatment Phase Study Terminated by Sponsor	0	0	0	0	0	1
Treatment Phase Withdrawal by Subject	0	0	0	0	0	1
Treatment Phase Global Deterioration of Health Status	0	0	1	0	0	2
Treatment Phase Other	0	0	0	1	0	1
Long-Term Follow-up Phase Death	2	3	2	4	2	6
Long-Term Follow-up Phase Study Terminated by Sponsor	1	1	0	0	2	8
Long-Term Follow-up Phase Withdrawal by Subject	0	0	1	1	1	2

Baseline Characteristics

Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC

Baseline characteristics by cohort

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Total n=36 Participants Total of all reporting groups
Age, Customized <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	0 Participants n=115 Participants
Age, Customized 18-44 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants
Age, Customized 45-64 years	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=10 Participants	19 Participants n=115 Participants
Age, Customized ≥65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants	13 Participants n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	11 Participants n=10 Participants	24 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=10 Participants	12 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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	0 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	16 Participants n=10 Participants	36 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	15 Participants n=10 Participants	32 Participants n=115 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized Other	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	0 Participants n=115 Participants
Race/Ethnicity, Customized Unknown	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	0 Participants n=115 Participants
Race/Ethnicity, Customized Multiracial	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	0 Participants n=115 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	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months after End of Treatment (EOT; 22 months in maximum)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or considered to be an important medical event. AEs included both SAEs and non-serious AEs.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with all-causality AEs	3 Participants	5 Participants	3 Participants	4 Participants	5 Participants	16 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with treatment-related SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with treatment-related AEs	1 Participants	5 Participants	1 Participants	4 Participants	3 Participants	14 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with all-causality SAEs	2 Participants	4 Participants	2 Participants	3 Participants	1 Participants	6 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months after EOT (22 months in maximum)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grades of AEs were defined by NCI CTCAE v5.0. Grade 1 = asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4 = events with life-threatening consequences, urgent intervention indicated; Grade 5 = death related to AE.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With AEs as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) (Grade ≥3) Grade 3 or Grade 4 (all-causality)	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With AEs as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) (Grade ≥3) Grade 3 or Grade 4 (treatment-related)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With AEs as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) (Grade ≥3) Grade 5 (all-causality)	2 Participants	4 Participants	2 Participants	1 Participants	1 Participants	6 Participants
Number of Participants With AEs as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) (Grade ≥3) Grade 5 (treatment-related)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months after EOT (22 months in maximum)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With AEs Leading to Discontinuation or Dose Reduction Number of participants with permanent discontinuations	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With AEs Leading to Discontinuation or Dose Reduction Number of participants with dose reduction or temporary discontinuations	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: The first 28 days following the first AdC68 vaccination (Cycle 1 Day 1)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

AEs in the first 28 d (days) following the first AdC68 vaccination that were considered possibly related to study treatment and not to disease/progression were DLTs: Grade≥3 neutropenia lasting>7 d, febrile neutropenia, Grade≥3 neutropenic infection, Grade≥3 thrombocytopenia with Grade≥2 clinically significant bleeding, Grade≥3 anemia lasting >7 d, Grade≥3 lymphopenia lasting>14 d; Grade≥3 lab abnormalities associated with symptoms or worsening of an existing condition or that suggested a new disease process or that required additional active management, Grade≥3 AEs considered non-hematologic, non-hepatic major organ toxicity, Grade 3 flu-like symptoms lasting>3 d, fever of >40.0 degree Celsius lasting>3 d, concurrent aspartate aminotransferase or alanine aminotransferase >3x upper limit of normal (ULN) and total bilirubin >2x ULN (potential Hy's law case). Other clinically important or persistent toxicities at discretion of investigator and Pfizer.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months after EOT (22 months in maximum)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

Laboratory abnormalities (graded per NCI CTCAE v5.0: Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) in at least 1 participant with data in the categories are presented here. Hematology parameters included hemoglobin, platelets, white blood cell (WBC) count, neutrophils, eosinophils, monocytes, basophils and lymphocytes. Coagulation should include prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (APTT).

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation (Grade 3 or 4) APTT prolonged	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation (Grade 3 or 4) Anemia	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation (Grade 3 or 4) Lymphocyte count decreased	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation (Grade 3 or 4) Neutrophil count decreased	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation (Grade 3 or 4) Platelet count decreased	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Hematology and Coagulation (Grade 3 or 4) WBC count decreased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months after EOT (22 months in maximum)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

Chemistry abnormalities (graded per NCI CTCAE v5.0: Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) in at least 1 participant with data in the categories are presented here. Chemistry parameters included aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, total chloride, total calcium, total bilirubin, blood urea nitrogen (or urea), creatinine, uric acid, glucose (nonfasted), albumin, phosphorous or phosphate, lactate dehydrogenase, lipase, amylase, bicarbonate or carbon dioxide, total protein, TSH (reflex free T4 and free T3).

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hyponatremia	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Alanine aminotransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Alkaline phosphatase increased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Aspartate aminotransferase increased	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Blood bilirubin increased	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hyperglycemia	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hyperkalemia	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Hypophosphatemia	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Lipase increased	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4) Serum amylase increased	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 months after EOT (22 months in maximum)

Population: The safety analysis set included all enrolled participants who received at least 1 dose of one of the components of the regimen.

Urinalysis abnormalities (graded per NCI CTCAE v5.0: Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated) in at least 1 participant with data in the categories are presented here. Urine parameters included urine protein and urine blood.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With Laboratory Abnormalities in Urinalysis (Grade 3 or 4)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Performed every 8 weeks from baseline up to Week 32

Population: All enrolled participants who received at least 1 dose of all regimen components administered on Cycle 1 Day 1 and must at least 1 valid and determinate assay result related to the proposed analysis. This was a primary endpoint of Part 2. Part 2 of the study was never opened as the study terminated.

Clinical Benefit Rate (CBR) is defined as the proportion of participants who achieved anti-tumor responses of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for >6 months. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). All target lesions must be assessed. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. All target lesions must be assessed. SD: Does not qualify for CR, PR or Progression. SD can follow PR only in the rare case that the sum increases by <20% from the nadir, but enough that a previously documented 30% decrease no longer holds.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: at pre-dose on Days 1, 3-6, 8, 15, 22, 29, 57, 85; Cycle 2: at pre-dose on Day 1 and Day 29; EOT; Months 2, 4, and 6 after EOT visit

Population: According to PK analysis reporting defined in protocol, the concentration-time data of sasan after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 4A and 5A. Sasan PK parameters in Cohort 6A were not calculated because by design only sparse PK samples were collected. Cohorts 1A, 2A and 3A were not included in the analysis since sasan was not administered in those cohorts.

Cmax was defined as the maximum observed serum concentration.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=4 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Maximum Observed Serum Concentration (Cmax) of Sasanlimab	10520 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 46	15640 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 82	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: at pre-dose on Days 1, 3-6, 8, 15, 22, 29, 57, 85; Cycle 2: at pre-dose on Day 1 and Day 29; EOT; Months 2, 4 and 6 after EOT visit

Population: According to PK analysis reporting defined in protocol, the concentration-time data of treme after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 3A and 6A. Treme PK parameters in Cohort 4A and 5A were not calculated because only sparse PK samples were collected. Cohorts 1A and 2A were not included in the analysis since treme was not administered in those cohorts.

Cmax was defined as the maximum observed serum concentration.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=14 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Cmax of Tremelimumab	1692 ng/mL Geometric Coefficient of Variation 47	4550 ng/mL Geometric Coefficient of Variation 62	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: at pre-dose on Days 1, 3-6, 8, 15, 22, 29, 57, 85; Cycle 2: at pre-dose on Day 1 and Day 29; EOT; Months 2, 4 and 6 after EOT visit

Population: According to PK analysis reporting defined in protocol, the concentration-time data of sasan after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 4A and 5A. Sasan PK parameters in Cohort 6A were not calculated because by design only sparse PK samples were collected. Cohorts 1A, 2A and 3A were not included in the analysis since sasan was not administered in those cohorts.

Tmax was defined as the time to reach maximum observed serum concentration.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=4 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Time to Maximum Concentration (Tmax) of Sasanlimab	165.0 Hour Interval 145.0 to 167.0	251.5 Hour Interval 69.6 to 499.0	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: at pre-dose on Days 1, 3-6, 8, 15, 22, 29, 57, 85; Cycle 2: at pre-dose on Day 1 and Day 29; EOT; Months 2, 4 and 6 after EOT visit

Population: According to PK analysis reporting defined in protocol, the concentration-time data of treme after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 3A and 6A. Treme PK parameters in Cohort 4A and 5A were not calculated because only sparse PK samples were collected. Cohorts 1A and 2A were not included in the analysis since treme was not administered in those cohorts.

Tmax was defined as the time to reach maximum observed serum concentration.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=14 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Tmax of Tremelimumab	284.0 Hour Interval 163.0 to 334.0	166.0 Hour Interval 69.5 to 683.0	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: at pre-dose on Days 1, 3-6, 8, 15, 22, 29, 57, 85; Cycle 2: at pre-dose on Day 1 and Day 29; EOT; Months 2, 4 and 6 after EOT visit

Population: According to PK analysis reporting defined in protocol, the concentration-time data of sasan after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 4A and 5A. Sasan PK parameters in Cohort 6A were not calculated because by design only sparse PK samples were collected. Cohorts 1A, 2A and 3A were not included in the analysis since sasan was not administered in those cohorts.

AUCinf was defined as area under the concentration time curve from time 0 extrapolated to infinity. AUCinf of sasanlimab was not reported due to the limited data points during elimination phase, and the lack of a well-characterized terminal phase. A well-characterized terminal phase was defined as one with at least 3 data points, r^2 ≥0.9, and percent of AUCextrap% ≤20%.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=4 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Area Under the Curve From Time 0 Extrapolated to Infinity (AUCinf) of Sasanlimab	NA ng*hr/mL Geometric Coefficient of Variation NA AUCinf of sasanlimab was not reported due to the limited data points during elimination phase, and the lack of a well-characterized terminal phase.	NA ng*hr/mL Geometric Coefficient of Variation NA AUCinf of sasanlimab was not reported due to the limited data points during elimination phase, and the lack of a well-characterized terminal phase.	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: at pre-dose on Days 1, 3-6, 8, 15, 22, 29, 57, 85; Cycle 2: at pre-dose on Day 1 and Day 29; EOT; Months 2, 4 and 6 after EOT visit

Population: According to PK analysis reporting defined in protocol, the concentration-time data of treme after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 3A and 6A. Treme PK parameters in Cohort 4A and 5A were not calculated because only sparse PK samples were collected. Cohorts 1A and 2A were not included in the analysis since treme was not administered in those cohorts.

AUCinf was defined as area under the concentration time curve from time 0 extrapolated to infinity. AUCinf of tremelimumab was not reported due to the limited data points during elimination phase, and the lack of a well-characterized terminal phase. A well-characterized terminal phase was defined as one with at least 3 data points, r^2 ≥0.9, and percent of AUCextrap% ≤20%.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=14 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
AUCinf of Tremelimumab	NA ng*hr/mL Geometric Coefficient of Variation NA AUCinf of tremelimumab was not reported due to the limited data points during elimination phase, and the lack of a well-characterized terminal phase.	NA ng*hr/mL Geometric Coefficient of Variation NA AUCinf of tremelimumab was not reported due to the limited data points during elimination phase, and the lack of a well-characterized terminal phase.	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: at pre-dose on Days 1, 3-6, 8, 15, 22, 29, 57, 85; Cycle 2: at pre-dose on Day 1 and Day 29; Months 2, 4, 6 after EOT visit

Population: According to PK analysis reporting defined in protocol, the concentration-time data of sasan after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 4A and 5A. Sasan PK parameters in Cohort 6A were not calculated because by design only sparse PK samples were collected. Cohorts 1A, 2A and 3A were not included in the analysis since sasan was not administered in those cohorts.

Ctrough was defined as the drug concentration observed at the last planned timepoint prior to dosing. Ctrough was not calculated for sasanlimab because trough concentration prior to the fifth dose (on Cycle 2 Day 1) were not collected for any participants in Cohorts 4A or 5A.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: at pre-dose on Days 1, 3-6, 8, 15, 22, 29, 57, 85; Cycle 2: at pre-dose on Day 1

Population: According to PK analysis reporting defined in protocol, the concentration-time data of treme after the 1st dose were analyzed individually by noncompartmental methods to determine PK parameters for participants in Cohorts 3A and 6A. Treme PK parameters in Cohort 4A and 5A were not calculated because only sparse PK samples were collected. Cohorts 1A and 2A were not included in the analysis since treme was not administered in those cohorts.

Ctrough was defined as the drug concentration observed at the last planned timepoint prior to dosing.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=1 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=2 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Ctrough of Tremelimumab	NA ng/mL Geometric Coefficient of Variation NA Summary statistics were not computed for PK parameters when fewer than 3 participants had non-missing data.	NA ng/mL Geometric Coefficient of Variation NA Summary statistics were not computed for PK parameters when fewer than 3 participants had non-missing data.	—	—	—	—

SECONDARY outcome

Timeframe: Performed every 8 weeks from baseline up to Week 32

Population: All enrolled participants who received at least 1 dose of all regimen components administered on Cycle 1 Day 1 and must at least 1 valid and determinate assay result related to the proposed analysis.

ORR was defined as the percentage of participants with best overall response based assessment of CR or PR according to RECIST v1.1. Per RECIST v1.1: CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All target nodes must decrease to normal size (short axis <10 mm). All target lesions must be assessed. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease and no new lesions. All target lesions must be assessed.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Objective Response Rate (ORR) Using RECIST v1.1	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 52.2	0 Percentage of participants Interval 0.0 to 70.8	0 Percentage of participants Interval 0.0 to 60.2	0 Percentage of participants Interval 0.0 to 52.2	0 Percentage of participants Interval 0.0 to 20.6

SECONDARY outcome

Timeframe: Performed every 3 weeks after treatment discontinuation until death, participant refusal, or lost to follow-up (telephone contact acceptable).

Population: All enrolled participants with NSCLC who received at least 1 dose of all regimen components administered on Cycle 1 Day 1 and must at least 1 valid and determinate assay result related to the proposed analysis.

PFS was defined as the time from start date to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after complete response or progression of pre-existing lesions.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=9 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Progression-Free Survival (PFS) Using RECIST v1.1 With NSCLC	2.0 Months Interval 0.4 to 2.0	1.8 Months Interval 1.8 to 5.3	1.8 Months Interval 1.7 to 1.9	1.8 Months Interval 0.6 to Not estimable based on the Brookmeyer and Crowley method.	—	—

SECONDARY outcome

Timeframe: Performed every 3 weeks after treatment discontinuation until death, participant refusal, or lost to follow-up (telephone contact acceptable).

Population: All enrolled participants with TNBC who received at least 1 dose of all regimen components administered on Cycle 1 Day 1 and must at least 1 valid and determinate assay result related to the proposed analysis.

PFS was defined as the time from start date to date of first documentation of progression, or death due to any cause. Progression was defined as the appearance of local, regional or distant disease of the same type after complete response or progression of pre existing lesions.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=1 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=3 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=2 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=7 Participants Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
PFS Using RECIST v1.1 With TNBC	1.2 Months Not estimable based on the Brookmeyer and Crowley method.	7.0 Months Interval 2.0 to 12.0	1.3 Months Interval 1.2 to 1.7	1.9 Months Interval 1.7 to 2.0	1.8 Months Interval 0.8 to 3.7	—

SECONDARY outcome

Timeframe: Cycle 1: on Day 1, Day 29, and Day 85; Cycle 2: on Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples to be collected on dosing days were obtained within 6 hours prior to sasanlimab dosing.

Population: All enrolled participants who received at least 1 dose of the VBIR-2 component was the participant of the immunogenicity assessment (tremelimumab or sasanlimab). For this outcome measure, participants who received sasanlimab in Cohorts 4A, 5A and 6A were included.

Participants were considered ADA-positive if (1) baseline titer was missing or negative and participant had ≥1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample (treatment-boosted).

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=4 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With Anti-Drug Antibody (ADA) Against Sasanlimab Treatment-induced	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Anti-Drug Antibody (ADA) Against Sasanlimab Treatment-boosted	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: on Day 1, Day 29, and Day 85; Cycle 2: on Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples to be collected on dosing days were obtained within 6 hours prior to sasanlimab dosing.

Population: All enrolled participants who received at least 1 dose of all assigned regimen components administered, and must have had at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, NAb against sasanlimab was examined for the 2 participants with ADA positive samples at baseline in Cohort 6A.

A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample (treatment-boosted). Participants who were either (1) an ADA-negative participant or (2) an ADA-positive participant without treatment-induced or treatment-boosted NAb response were considered as NAb negative.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=2 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With Neutralizing Antibody (NAb) Against Sasanlimab	—	—	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Cycle 1: on Day 1, Day 29, and Day 85; Cycle 2: on Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.

Population: All enrolled participants who received at least 1 dose of the VBIR-2 component was the participant of the immunogenicity assessment (tremelimumab or sasanlimab). For this outcome measure, participants who received tremelimumab in Cohorts 3A, 4A, 5A and 6A were included.

Participants were considered ADA-positive if (1) baseline titer was missing or negative and participant had ≥1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample (treatment-boosted).

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 Participants Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=4 Participants Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=5 Participants Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=16 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Number of Participants With ADA Against Tremelimumab Treatment-induced	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With ADA Against Tremelimumab Treatment-boosted	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Cycle 1: on Day 1, Day 29, and Day 85; Cycle 2: on Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples to be collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.

Population: All enrolled participants who received at least 1 dose of all assigned regimen components administered, and must have had at least 1 valid and determinate assay result related to the proposed analysis.

A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ratio of ≥4 in titer (dilution) to baseline in ≥1 post-treatment sample (treatment-boosted). Participants who were either (1) an ADA-negative participant or (2) an ADA-positive participant without treatment-induced or treatment-boosted NAb response were considered as NAb negative. NAb evaluation was not considered as meaningful taken that treatment-induced ADA was found in only 1 participant. Thus, NAb to tremelimumab was not examined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples to be collected on dosing days were obtained within 6 hours prior to sasanlimab dosing.

Population: All enrolled participants who received at least 1 dose of all assigned regimen components administered, and must have had at least 1 valid and determinate assay result related to the proposed analysis. For this outcome measure, participants who received sasanlimab in Cohorts 4A, 5A and 6A were included. No participants had treatment-induced ADA.

Titers were measured in terms of 1/dilution. Only the samples tested positive for ADA were to be further tested for Nab. Treatment-induced ADA: baseline titer is missing or negative and participant has >= 1 post-treatment positive titer. Treatment-induced NAb: baseline titer was missing or negative and participant had ≥1 post-treatment positive titer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1: at Day 1, Day 29, and Day 85; Cycle 2: at Day 29; at the EOT visit, and 2, 4 and 6 months after EOT. Samples to be collected on dosing days were obtained within 6 hours prior to tremelimumab dosing.

Population: All enrolled participants who received at least 1 dose of all assigned regimen components administered, and must have had at least 1 valid and determinate assay result related to the proposed analysis.

Titers were measured in terms of 1/dilution. Only the samples tested positive for ADA were to be further tested for Nab. Treatment-induced ADA: baseline titer is missing or negative and participant has >= 1 post-treatment positive titer. Treatment-induced NAb: baseline titer was missing or negative and participant had ≥1 post-treatment positive titer. NAb was not examined as the evaluation was not meaningful considering only 1 participant had treatment-induced ADA.

Outcome measures

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=1 Participants Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Titers of Treatment-Induced ADA and NAb Against Tremelimumab ADA Titer	—	—	—	NA 1/dilution No summary statistics were provided for N \<3 considering the insufficient number of participants with event (only 1 participant with treatment-induced ADA).	—	—

Adverse Events

Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg

Serious events: 4 serious events

Other events: 5 other events

Deaths: 4 deaths

Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 2 deaths

Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg

Serious events: 6 serious events

Other events: 16 other events

Deaths: 6 deaths

Serious adverse events

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 participants at risk Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Eye disorders Diplopia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Nausea	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Chest pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Death	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Disease progression	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Hepatobiliary disorders Jaundice	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Biliary sepsis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Peritonitis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Pneumonia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Sepsis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Hepatic enzyme increased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 2/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Cerebral haemorrhage	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Mental status changes	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Renal vein thrombosis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Vascular disorders Aortic aneurysm	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.

Other adverse events

Measure	Cohort 1A Adenovirus C68 (AdC68) 2X10^11 Viral Particles (VP) + Plasmid DNA (pDNA) 5 mg n=3 participants at risk Participants with advanced non-small cell lung cancer (NSCLC) or metastatic triple negative breast cancer (mTNBC) in Cohort 1A received 2 repeated cycles of treatment, including AdC68 2x10\^11 VP intramuscularly (IM) on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 2A AdC68 6X10^11 VP + pDNA 5 mg n=5 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 2A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, and pDNA 5 mg IM on Days 29, 57, and 85 of Cycles 1 and 2.	Cohort 3A AdC68 6X10^11 VP + pDNA 5 mg + Tremelimumab (Treme) 40 mg n=3 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 3A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2, pDNA 5 mg IM and treme 40 mg subcutaneously (SC) on Days 29, 57, and 85 of Cycles 1 and 2. Treme was administered after AdC68 or pDNA.	Cohort 4A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasanlimab (Sasan) 130 mg n=4 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 4A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 130 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after Treme.	Cohort 5A AdC68 6X10^11 VP + pDNA 5 mg + Treme 40 mg + Sasan 300 mg n=5 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 5A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 40 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.	Cohort 6A AdC68 6X10^11 VP + pDNA 5 mg + Treme 80 mg + Sasan 300 mg n=16 participants at risk Participants with advanced NSCLC or mTNBC in Cohort 6A received 2 repeated cycles of treatment, including AdC68 6x10\^11 VP IM on Day 1 of Cycles 1 and 2; pDNA 5 mg IM, treme 80 mg SC, and sasan 300 mg SC on Days 29, 57, and 85 of Cycles 1 and 2. Sasan was administered after AdC68 or pDNA and after treme.
Infections and infestations Rash pustular	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Acute left ventricular failure	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Cardiac disorders Tachycardia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Eye disorders Diplopia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Eye disorders Photopsia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Eye disorders Vision blurred	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Ascites	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Constipation	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 2/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 4/16 • Number of events 4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 2/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Lip pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	31.2% 5/16 • Number of events 5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Asthenia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Axillary pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Chest pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Chills	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	75.0% 3/4 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	18.8% 3/16 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Fatigue	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	31.2% 5/16 • Number of events 6 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Influenza like illness	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	37.5% 6/16 • Number of events 6 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site bruising	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site erythema	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	60.0% 3/5 • Number of events 4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	43.8% 7/16 • Number of events 10 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site rash	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site reaction	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Injection site swelling	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Localised oedema	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Malaise	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Non-cardiac chest pain	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Oedema	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Oedema peripheral	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Peripheral swelling	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Pyrexia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 2/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	18.8% 3/16 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
General disorders Swelling	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Hepatobiliary disorders Jaundice	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Bronchitis	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Cystitis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Nail infection	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Oesophageal infection	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Paronychia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Pneumonia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Sepsis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Sinusitis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Infections and infestations Urinary tract infection	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Seroma	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 8 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Amylase increased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	18.8% 3/16 • Number of events 8 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood bilirubin increased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Lipase increased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Lymphocyte count decreased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Investigations Troponin increased	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	18.8% 3/16 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	60.0% 3/5 • Number of events 4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 2/5 • Number of events 11 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	18.8% 3/16 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	18.8% 3/16 • Number of events 4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 2/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Aphasia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Brain oedema	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Dizziness	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 2/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Electric shock sensation	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Headache	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	50.0% 2/4 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Hydrocephalus	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Hypersomnia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Paraesthesia	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Presyncope	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Seizure	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Nervous system disorders Syncope	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Agitation	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Anxiety	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Confusional state	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Depression	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 2/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Psychiatric disorders Mental status changes	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Renal and urinary disorders Chromaturia	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Reproductive system and breast disorders Penile rash	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	75.0% 3/4 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	31.2% 5/16 • Number of events 5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	40.0% 2/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	18.8% 3/16 • Number of events 3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	20.0% 1/5 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	12.5% 2/16 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Vascular disorders Hypertension	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	25.0% 1/4 • Number of events 2 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	6.2% 1/16 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.
Vascular disorders Orthostatic hypotension	33.3% 1/3 • Number of events 1 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/3 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/4 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/5 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.	0.00% 0/16 • Baseline up to 6 months after EOT (22 months in maximum) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AE reporting, including suspected unexpected serious adverse reactions, was carried out in accordance with applicable local regulations.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER